India is well known for its largest supplier of medical drugs globally and hence enjoys a key position across the globe having potential researchers and scientists. Indian pharmaceutical sector is the provider of almost 50 percent of global demand for various vaccines and anaesthetics, around 40 per cent of generic demand in the US and 25 per cent in UK. In the current scenario, Medicine usage and demand for drug supply in India is projected to grow over 9-12 per cent for the next five years, thereby leading India to become one of the top 10 countries in terms of medicine consumption. In the view of rising health concerns and diseases and chronic therapies for cardiovascular diseases, diabetic complications, cancers, etc., a better growth in domestic sales would be solely dependent on the ability of companies to align their product services. The Indian government has taken various steps for reaching health to all the needy like bringing generics drug supply into the market, reducing life savings drugs, vaccines costs and bring down the healthcare expenses to aid the needy and also health care programmes and campaigns.

In India, Pharma Knowledge Centre (PKC) is contributing to the best training and guidance, fulfilling the wide knowledge gap between Academia and Industry in making upcoming younger generation/students “Industry Ready” for Pharmaceutical Companies, Bio-pharmaceutical and Clinical Research Organizations. This platform can serve the needs of many students who wanted to land best in their career.

Why only PKC:

PKC is providing customized services to the students with regards to career growth in terms of quality consulting, Job training, Regulatory Compliance (GMP & global regulatory guidelines) and quality management/assurance for Pharmaceutical, Biopharmaceutical, Food industries, Medical device, Biotechnology and FMCG companies. PKC is unique in its training with the best provisions such as:

1. Learn and proper guidance from Industry Experienced Experts and certified trainers
2. Teaching Mode: Interactive Smart Classroom with German Technology
3. Classroom Sessions: Industry ready classrooms
4. Best Placement assistance
5. Around the corner Enquiry assistance
6. ISO Certified (ISO 9001)
7. Wide range of GMP Consultancy Customers
8. Trending and on demand training courses
9. Workshops on various fields
10. Advisory Council

India has established a strong domestic pharmaceutical industry with a network of almost 3000 drug companies and about 10,500 pharmaceutical manufacturing units, put of which 1,400 units are World Health Organization (WHO) good manufacturing practice (GMP) approved, 1,105 companies are with Europe’s certificate of suitability (CEPs), more than 950 match therapeutic goods administration (TGA) guidelines and 584 sites are approved by the regulatory agency US Food and Drug Administration (USFDA). The pharmaceutical hubs offer wide investment opportunities in the production of active pharmaceutical ingredients (API) or bulk drugs, biosimilars, vaccines, nutraceuticals and food products. Indian pharmaceutical companies produce around 80 percent of antiretroviral drugs worldwide to fight Acquired Immuno Deficiency Syndrome (AIDS).

Good Manufacturing Practices:

Good Manufacturing Practice (GMP) is a qualitative system for ensuring that products are consistently produced and controlled as per the required quality standards for health, safety and efficacy. GMP is specially brought into force and well designed to minimize the potential risks involved in any pharmaceutical production that intends to harm the patients, environment and cannot be eliminated through testing the final outcome. GMP is followed in every step from raw material to production of desired drugs. GMP in simple focuses on five key elements, which are often termed as the 5 P’s of GMP—people, premises, processes, products and procedures or paperwork. When all five elements are fulfilled, GMP is compliance is satisfactorily completed for the drug production. For Indian pharma, Schedule M describes the quality aspects like quality assurance, self-inspection, and quality control system requirements, listing the requirements for the premises, materials, plant and equipment.

GMPs are more essential into the manufacturing practices for achieving the high-quality products for satisfying the customers. There would be a varied requirement in terms of manufacturing processes for various products. Hence the good in GMPs within the context of the manufacturing multiple food and drug products need to be strictly followed. GMP provides all the exclusive and well-designed guidelines for the processes in the pharma industries.

A need for AMPs (Appropriate Manufacturing Practices), an equally more important and alternative to GMPs are required to be refined based on the clear-cut fulfilment of the desired product and its manufacturing processes. AMPs require justifying the essential process requirements as there would be multiple routes in product quality achievement. Building AMPs facilitates the opportunities for amending the sequence of process, people, facility and infrastructure practices that are used to achieve high product quality. AMPs are in compliance with that of GMP but can also initiate novel methodological approaches crucially important in solving the potential challenges into existence through advanced technologies with regard to the prospective optimization of various process, facility and infrastructure configurations.

Why do Pharma Industry need AMPs?

With the entry of AMPs would not only serve the higher product quality specifications, but also pharma industries would be in alignment with the regulatory bodies and most importantly FDA. There is a strong need for the industries to improvise their approach and methods in drug manufacturing. In view of the pharma industries and the systems followed critical quality attributes need to be driven with the more advanced and sophisticated developmental approaches for the quality performance and output.

Advanced tools and qualitative approaches like quality by design (QbD) and ICH Q8 Design Space are into force. For the higher rates of successful commercialization which in turn yields better quality products, Pharma sector needs a better emphasis on life cycle integration of information and knowledge from the medical or scientific research through commercial manufacturing for the development of AMPs.

Pharma industry must be furious to spotlight the effective modes of quality risk management and assessment and work on the development of QRM methods. Risk management is the crucial aspect in the pharma industry and currently, the approaches in ICH Q9 – QRM like failure mode and effect analysis (FMEA) and hazard analysis at critical control points (HACCP) details the methods for structuring risks, however there is no proper mechanism in assessing uncertainty of the risks, leading to the unintended use of the costly and inefficient precautionary principle (the most notable saying better safe than sorry), resulting in suboptimal risk management.

With the evolution of AMPs into Pharma, there would be a high chance for the opportunities in the modernization of manufacturing processes and facilities that are highly capacity-efficient which enables rapid access to flexible manufacturing assets and thus granting towards much faster cum more efficient product development. Advancement in strong quality management systems, establishing robust operating procedures through advanced facility designs can also expedite less regulatory approvals and supports quality continuous manufacturing.

 Major Industry’s Challenge

Pharmaceutical industry is highly facing major challenges in terms of drug development, product failures, clinical trial quality, quality issues and patent issues for long time. In view of the challenges, Indian pharma industry is losing potential ability to develop new products, but it strongly suggests that the pharma industry as a whole needs to alter the methodological approach towards developing new drugs, drug approvals, commercialization and manufacturing of new drug products. Indian pharma claims the challenges like: Pricing of patented drugs, control of drug pricing by government (To ensure that high-quality generic medicines reach needy patients at most affordable price), fake drug products, lack of skilled man force, and dependant on China for raw materials.

Pharma digitalization will bring about major difference in approach and industry will observe sustainable growth opportunities in next decade. The way forward, Pharma industry need to strive for the nation’s quality healthcare.  Also, regulatory policies need be improved, mainly in the area of patent and price control, to boost the pharma growth for the newer generation pharmaceutical market.

The FDA’s Challenge for Pharma Industry:

 FDA is one of major regulatory body inspecting pharma industries to be more focused on developing practices for its drug products and manufacturing processes complying with cGMP. The systematic approach would always force the drug industry to identify product requirement, developmental methods, and implementing practice-based control systems necessary to satisfy GMP requirements. Many of the Indian manufacturing facilities struggle to maintain proper documentation (data integrity) of testing and sample data. “The USFDA has also been increasingly issuing warning letters to the Indian companies, denying any GMP compliance. In the recent times, FDA announced carcinogenic impurities identified Ranitidine products.

Can Pharma manufacturers really afford to implement AMPs?

Many pharmaceutical manufacturers are already in line with cGMPs that implement comprehensive, modern quality systems and risk management approaches. Today’s pharma world is all moving around the fashionable motto of being patient-focused, as patient is the ultimate end user of life saving drug products. Manufacturing poor quality products does not serve the real essence of Pharma industry in saving lives and it’s just a money waste process. Poor quality drugs also disturb community health and leads to loss of credibility for everyone. Also, in the long run it would create a havoc and expensive deal in finding out the errors or root cause for eradicating recurrence. GMP is more prominently designed to ensure that no mistakes occur in drug manufacturing. Investing in GMP implementation adds value to the pharma industry and thereby produces good quality medicines. This will further aid in improving the health of the individual patient and the community, as well as commercially benefiting the pharmaceutical industry. AMPs would bring about a considerable change by reimagining the current regulatory approaches and making industry fully responsible for all the practices. Also, the industry will rise to the challenge and eliminate all the obvious and incompetent compliance errors mostly found in FDA inspections.

AMPs, just like GMPs would bring about greater and prospective resolutions to many of the complex issues faced by Pharma industries. However, AMPs implementation would pose an extra burden to the industry in its problem-solving approach. Aligning with the FDA is also a tougher job for the Pharma industries. For a shift or movement from the existing GMPs to AMPs will certainly require better approaches for interacting between the agency and industry. Also the novel transformation would require the regulatory body – FDA to collectively and aggressively join to work on par with pharma industry to learn and understand the appropriate practices defined/followed by the industry to achieve the production of high product quality with appropriate practice-based controls required. Both industry and FDA can work together using FDA’s Voluntary Consensus Standards (VCS) to analyse better approaches for efficiently managing product life cycles in high gear and rewardingly bring new therapies to serve the patient community in need.

References

1. https://www.pharmaguideline.com/2012/08/current-good-manufacturing-practice-cgmp.html
2. https://www.ibef.org/industry/pharmaceutical-india.aspx
3. https://www.ibef.org/industry/indian-pharmaceuticals-industry-analysis-presentation
4. https://www.pwc.in/press-releases/india-pharmaceutical-industry-is-on-a-good-growth-path.html
5. http://www.pharmabiz.com/
6. https://pharmawiki.in/indian-pharmaceutical-industry-overview-analysis-2018-pdf-ppt/
7. https://www.pharmatimesnow.com/2018/10/overview-of-pharmaceutical-industry23.html
8. https://www.linkedin.com/pulse/strategic-thinking-pharmaceutical-industry-today-adeel-ahmed
9. https://myassignmenthelp.co.uk/freesample/critical-thinking-for-pharmaceutical-industry
10. https://blog.experiencepoint.com/why-pharma-needs-design-thinking
11. https://link.springer.com/chapter/10.1007/978-981-13-8102-7_13
12. https://www.fda.gov/about-fda/office-global-operations/india-office
13. https://www.fda.gov/drugs/pharmaceutical-quality-resources/facts-about-current-good-manufacturing-practices-cgmps
14. https://ispe.org/initiatives/regulatory-resources/gmp/what-is-gmp
15. https://www.pharmaceuticalonline.com/doc/fda-s-top-drug-gmp-inspection-citations-in-fy-with-fda-analysis-0001
16. https://www.igmpiindia.org/IndianPharmacompaniesshouldfollowGMPregulationsstrictlyUSFDA.html
17. https://ispe.org/pharmaceutical-engineering/ispeak/facility-challenges-developing-continuous-process-based-biopharma-products
18. The future of pharmaceutical quality and the path to get there. https://europepmc.org/article/med/28619448

Pharma Knowledge Centre – “My Learning Life” (PKC) engaged Young Indian Youths to prepare this presentation/Blog and the same has been prepared by one of the associated youngsters in consultation with PKC.

All rights reserved. All copyright in this presentation and related works is solely and exclusively owned by PKC. The same may not be reproduced, wholly or in part in any material form (including photocopying or storing it in any medium by electronic means and whether or not transiently or incidentally to some other use of this presentation), modified or in any manner communicated to any third party except with the written approval of PKC.

This presentation is for information purposes only. While due care has been taken during the compilation of this presentation to ensure that the information is accurate to the best of associate and PKC’s knowledge and belief, the content is not to be construed in any manner whatsoever as a substitute for professional advice.

Associate and PKC neither recommend nor endorse any specific products or services that may have been mentioned in this presentation and nor do they assume any liability or responsibility for the outcome of decisions taken as a result of any reliance placed on this presentation.

Neither any associate nor PKC shall be liable for any direct or indirect damages that may arise due to any act or omission on the part of the user due to any reliance placed or guidance is taken from any portion of this presentation.

The post An Overview of Current Indian Pharma Industry: A Quality Approach GMP Vs AMP appeared first on Pharma Knowledge Centre.

Medical sales and marketing is one of the best ways to enter into the Pharma industry, always an exciting and career demanding path. Medical representatives, (in short usually known as MR’s or Medical Reps) act as a key contact between medical and pharmaceutical companies and healthcare professionals.

Medical sales jobs will always be in great demand. Though current industry is running towards online sales and advanced technologies, medical sales require a major extent of face-to-face market in the industry.

Is Medical Representative Profession good?

If you are eagerly looking for a job that will constantly require doing something new always and moving out with passion, then medical sales representative may be the one which ultimately suits for you. This piece of article tries to advise interested candidates to enter the industry?

A Career in Pharmaceutical Sales and Marketing!

 Pharma sales career would be quite interesting and challenging to succeed. The main job of Medical representatives is to educate health care community professionals on the drugs and medical devices they need to prescribe for the best medical care to the patients. Medical sales include a variety of Pharma products like: Pharmaceutical drugs, Medical devices (includes artificial joints, biomedical implants, heart pacer, dental implants), Medical equipment and Biotechnology products, etc.

This Job demands various skills (communication and presentation skills, online marketing skills, etc.) Medical representative field like other streams also has growth and sustainability.

How to Begin: Medical Representative Career

Here comes the ways to become a successful medical representative.  The foremost step is to attain proper degree with the specialization (Life Sciences, Health care, medical devices and equipment, pharmaceuticals and biotechnology).

Education Requirement: A graduate Degree in Life Sciences, Pharmacy, Medicine, Nursing, Dentistry or related medical field. Sales & Management (medical hospitality or hospital management, medical sales) and Master’s in Business Administration would be an added advantage. Medical representatives are usually those with B pharmacy graduation. Paramedical and any life science courses can also be sufficient to become medical sales professional.

Required skills for Medical Sales Jobs:

Subject Knowledge, Strong interpersonal and communication Skills, Excellent Presentation skills, Sales Knowledge, Business skills, Analytical Skills, Organization and Planning Skills, Marketing Skills, Patience, Self-Motivation, Confidence levels, Commercial awareness, Customer relationship and negotiating skills, etc.

Technical Requirements for Medical Representatives:

• Familiarity with computers and Microsoft Office and technical writing.
• Should be proficient in the use of modern technology, especially electronic gadgets like smart phones and computers.
• Stay updated with the emerging trends in technology central to medical sales
• Social media and online network experience is required.

Other Requirements for Medical Representatives:

• Proper dressing sense and well-mannered behavior is required.
• Driving is also must requirement with a valid driving license for this Job (This Job requires travelling for sales and promotion).

Job Training:

Job training is kind of skill enhancement program dealing with pharmaceutical science, marketing, sales etc. If you are enough interested to choose pharmaceutical sales career, i.e., to start with becoming Medical Representative, Training courses will be helpful. These courses would be offered by various institutes and Pharmaceutical training providers that include Pharma Knowledge Centre.

Enroll in a training program from reputed Organization either online or offline (i.e., in-person training). Training provides the best knowledge in various aspects and makes the individual industry ready to pick up the Job easily. The topics for training include: Pharma industry introduction, Pharmaceutical industry working nature, industry standards, industry acronyms, medical terminology, human physiology, human anatomy, human diseases-pathology, disease management, treatment methods, medication, pharmacology, drugs formulas, compositions, drug storage, transportation methods, sales, industry guidelines and standards etc. To start up good and end up with good job, training will be a best option for medical sales jobs.

Certification: Get licensed or certified from recognized organizations. Certifications aid with career advancement and improve your sales knowledge. Certification is not mandatory but can serve as an added advantage with improved industry updates and selling techniques. The National Association of Pharmaceutical Sales Reps (NAPSR) offers a certification program and awards “Certified National Pharmaceutical Representative” (CNPR).

Work/Field Experience:

Working knowledge of sales or Field experience would definitely fetch you with plenty of job opportunities. After earning degrees, certifications and training, it would be the next level to gain experience. Experience can be attained by various modes like taking up an Internship with Pharma sales companies, taking an entry-level job or approaching any startups, Job shadowing is an effective form of job training for medical sales representatives, Volunteering at a hospital or doctor’s clinic for gaining experience. Work Experience is a big plus that can add weight to the curriculum vitae which would attract hiring managers to contact you.

Job Profile of a Medical Representative:

Medical Representative Job profile is solely responsible for the product promotion and its sales through meeting highly qualified customers. Products include all Medicines, Prescription drugs, medical devices, medical equipment’s and surgical kits.

Major Responsibilities of Medical Representative include:

• Advertising and selling Pharma products to relevant medical units.
• Organizing appointments and product meetings with healthcare professionals and medical staff.
• Planning for visiting hospitals.
• Identifying new business strategies and implementing
• Servicing current clients and establishing new sales accounts, resolving issues or complaints in a timely manner.
• Negotiating contracts when needed.
• Demonstrating or presenting products to healthcare staff (doctors, nurses and pharmacists, etc.)
• Undertaking relevant research on Products and sales, keeping up-to-date on current market trends.
• Maintaining detailed records and proper documents.
• Attending and organising trade exhibitions, conferences and scientific meetings
• Managing budgets and Reviewing sales performance
• Focusing sales efforts by studying client requirements and increasing sales.
• Cold calling potential clients.

Potential Clients or Customers include: Doctors, Nurses, Physicians, General Practitioners (GPs), Medical/Health care Professionals from healthcare institutes/clinics, Medical Staff, Pharmacists, Drug Manufacturing Companies, Stockists and Retailers.

Major Employers: Many national and multinational companies (Pharma, Medical Equipment, Medical Devices, & Biotechnology companies) are employing medical sales professional in various profiles.

Pharmaceutical Companies:

Major Healthcare/medical and pharmaceutical companies employ medical sales or Pharma representatives that includes a big list of Multinational companies and Indian Pharma companies such as Johnson & Johnson, AbbVie Inc, GlaxoSmithKline (GSK), Sanofi, Bayer AG, Eli Lilly and Co, Merck & Co Inc, F Hoffmann-La Roche Ltd, Pfizer Inc, Novartis, Bristol-Myers Squibb (BMS), Merck & Co., Roche, Abbott Laboratories, Amgen, Gilead Sciences, AstraZeneca, Teva Pharmaceutical Industries, Takeda, Astellas Pharma, Aurobindo Pharma, Dr. Reddy’s Laboratories, Lupin Limited, Cipla Limited, Cadila Healthcare Limited, Intas Pharmaceuticals Limited, Piramal Enterprises Limited, Glenmark Pharma Limited, Sun Pharmaceutical Industries Limited, Biocon Limited, ManKind Pharma Limited, Boehringer Ingelheim, Wockhardt Limited, Divis Laboratories Limited, Zydus Cadila Healthcare, Torrent Pharmaceuticals Limited, Wyeth LLC, etc.

Biotechnology Companies:

AstraZeneca Pharma India, Accurex Biomedical, Advanced Enzyme Technologies, Anthem Biosciences, Ankur Seeds, Biocon, Biological E, Bharat Biotech International, Bhat Bio-Tech India, Concord Biotech, Ecron Acunova, GSK India, Jubilant Life Sciences, Mahyco, Metahelix Life Sciences, Nuziveedu Seeds, Panacea Biotec, Serum Institute of India, Syngene International, Troikaa Pharmaceuticals, Zytex, etc.

How to succeed in Pharma Sales field:

Pharmaceutical sales and marketing is large scale revenue yielding and high turnover business filed. To move on into successful career one requires lot of effort and determination. Every Medical representative need to carry special qualities like positive approach, communication skills, convincing nature, presentation skills, business and product knowledge, market value, proper research on sales. One must set to follow certain agenda in their working to be successful.

• Proper Aim.
• Approaching clients positively.
• Building trusty relationship.
• Business reviews.
• Choosing right people.
• Conducting call reviews.
• Understanding current market value of products.

Selling Style of medical Representatives to the Doctors/ Physician:

Regarding the product explanation, certain points need to be followed necessarily for successful business.

• Building trusty and amicable relationship with doctors and other health care or medical staff.
• Need to be very clear and precise about the product for sale.
• Product demonstrations need to be in pictorial (images/drawings/graphs) mostly in power point presentation for better understanding and catchy.
• Genuine product information (drug uses/advantages and disadvantages) needs to be shared properly without hiding any such information.
• Justifying the drug benefits with the supportive documents or clinical case studies.
• Proper communication and convincing skills are needed always.

Pay Scale and Compensation:

Pay scale would range according to the experience in the field. The starting salary would be minimal, however it would lucrative for those with good experience and better positions.  There is no such limit to earn with good determination and target oriented mentality. There is wide scope and opportunity for higher income and advancement in this field. Medical representatives earn additional perks and incentives on every product sale made as a commission pay.

If you are looking for a job training or placement in the pharmaceutical industry then do visit website of Pharma Knowledge Centre for more updated knowledge and information.

Benefits in Choosing Medical Sales Profile:

• Good earning capability.
• Perks and incentives based on product sales.
• Medical Benefits and other benefits (mobile phone and travel allowances).
• Good job profile for those who are interested in travelling as per the Job requirement.
• Work time flexibility.
• Contacting and interacting with new people on daily basis.
• Service to the people or society.

What are the major challenges faced by Medical Representatives:

The true challenge for a Pharma sales person would be:

• To convince a doctor or physician to switch from any drug that he or she is currently prescribing to their patients to the new drug as suggested by you.
• Selling to the right people is also an art of sales.
• To meet doctors/physician’s from his/her busy schedule of attending patients, which may take long waiting period.

Online Medical Pharmacy: Online Pharmacy will not affect Medical sales field having its own importance. Though technology is advanced, offline sales marketing has its importance.

What is online pharmacy? An online pharmacy, also known as internet pharmacy is a pharmacy that usually operates over the internet and sends the orders to customers through mail or shipping companies. E-Pharmacies include a list like 1mg, PharmEasy, Netmed, Medlife, etc. Medical representatives directly reach the customer for fast paced sales and business to occur. Most of the people do not depend on online pharmacies hence the demand for medical reps is growing.

How to Apply for Jobs:

Resume or CV: Your CV reflects everything about you, so prepare best CV including genuine and correct information. Experts can sort out the preparation of CV for you from Training institutes, etc. Nowadays, you need not wander around to search for Jobs. Just search jobs from various online resources like Naukri.com, Indeed.com, Timesjobs, Monster.com, and Glassdoor.com, etc. Also often visit the websites (career pages) of various pharmaceutical, medical and biotechnical companies for job openings.

As per the global  market research reports, Indian pharmaceuticals market is expected to be worth USD 33.18 billion and reach about 9th position in the global pharma market by the upcoming year 2023.

With the continuous growth and experience in the field of Pharma sales, one can move into the further roles like sales training, managerial levels, regional sales head, other higher positions, etc. Many pharmaceutical companies are multinational (MNCs) and hence many offers may also hit you to go abroad.

Having self-determination and motivation, one can achieve greater heights in career. There is limit for the growth in any career choice from Medical field. No one has any inborn qualities of best sales person or simply a born salesperson. One needs to gain experience from education, training and learning the required skills with keen interest and constant updation with the latest techniques and advancements.

Pharma Knowledge Centre can serve as an expert to guide your decisions in choosing bright career. The most important piece of advice or guidance this blog tries to give you is to keep learning every day from today onwards, set your goals high and aim to achieve with proper planning, education, training and experience. It all makes a better future in Pharma sales and marketing with fruitful career path laid to you – making you a great medical representative.

For more updates, information and proper career guidance, feel free to call on +91 8318127735 or email us at info@pharmaknowledgecentre.com. You can also find more info and latest updates on social media platforms. Keep following us on major networks like Linkedin, Facebook, Twitter and Instagram.

Wishing you a better career ahead, as your career guide search ends up with PKC giving you best results.

References

1. https://www.davidbagga.com/how-much-can-you-make-as-a-medical-sales-rep/
2. https://www.napsronline.org/cnpr-pharmaceutical-sales-program/break-into-a-pharmaceutical-sales-career/
3. https://bmjopen.bmj.com/content/7/9/e016408
4. https://apps.who.int/medicinedocs/pdf/s8109e/s8109e.pdf
5. https://www.abpi.org.uk/
6. https://www.allaboutcareers.com/careers/job-profile/medical-sales-representative
7. https://vibcare.co.in/role-of-medical-representative/
8. https://neuvoo.ca/neuvooPedia/en/sales-rep/
9. https://www.topmastersinhealthcare.com/job-profiles/pharmaceutical-sales-representative/
10. https://pharmaboardroom.com/articles/the-changing-role-of-the-medical-rep/
11. https://www.abpi.org.uk/medicine-discovery/academic-collaboration-education-skills/the-abpi-medical-representatives-exam/
12. https://www.ncbi.nlm.nih.gov/pubmed/29313642
13. https://www.prospects.ac.uk/job-profiles/medical-sales-representative
14. https://en.wikipedia.org/wiki/Online_pharmacy
15. https://www.bls.gov/ooh/sales/wholesale-and-manufacturing-sales-representatives.htm
16. https://www.pharmaceutical-technology.com/features/top-pharmaceutical-companies/
17. https://en.wikipedia.org/wiki/Pharmaceutical_industry_in_India
18. https://www.ibef.org/industry/pharmaceutical-india/showcase
19. https://en.wikipedia.org/wiki/Pharmaceutical_marketing
20. https://www.marketresearchreports.com/navadhi/india-pharmaceuticals-industry-analysis-and-trends-2023
21. https://apps.who.int/medicinedocs/en/d/Jh2989e/2.html
22. https://www.naukri.com/medical-representative-jobs
23. https://quacktrack.org/e-pharmacies-in-india-regulations-benefits-and-risks/

Pharma Knowledge Centre – “My Learning Life” (PKC) engaged Young Indian Youths to prepare this presentation/Blog and the same has been prepared by one of the associated youngsters in consultation with PKC.

All rights reserved. All copyright in this presentation and related works is solely and exclusively owned by PKC. The same may not be reproduced, wholly or in part in any material form (including photocopying or storing it in any medium by electronic means and whether or not transiently or incidentally to some other use of this presentation), modified or in any manner communicated to any third party except with the written approval of PKC.

This presentation is for information purposes only. While due care has been taken during the compilation of this presentation to ensure that the information is accurate to the best of associate and PKC’s knowledge and belief, the content is not to be construed in any manner whatsoever as a substitute for professional advice.

Associate and PKC neither recommend nor endorse any specific products or services that may have been mentioned in this presentation and nor do they assume any liability or responsibility for the outcome of decisions taken as a result of any reliance placed on this presentation.

Neither any associate nor PKC shall be liable for any direct or indirect damages that may arise due to any act or omission on the part of the user due to any reliance placed or guidance is taken from any portion of this presentation.

The post Job and career opportunities for Medical sales Representatives appeared first on Pharma Knowledge Centre.

Medical Billing would definitely be a best career path with abundant job opportunities especially for Life Science students and for also those from other backgrounds, who really wanted to invade billing field. Medical billing and coding are ruling the health care sector with faster growth rate at over 15-18% per year on average. This demanding growth has opened up wide variety career opportunities for students and skilled candidates. Well, if you are interested to shape your career in medical billing, go through the below basics about medical billing process, how and where to start with career? Happy Reading!

What is Medical Billing?

In Today’s World, Medical billing is said to be a complex and essential part of the health care system. Medical Billing is to prepare the bills (invoices) for the services rendered to the patients (medical procedures), and the prepared bills are submitted to patients and the insurance companies. Medical Billing procedure coordinates or plays an intermediary role between patients, providers, and the payers.

I hope by now, it is clear that the Medical Billing involves billing process in health care field. It provides bills for the reimbursement procedures for both patients and insurance companies. Healthcare providers require medical billers for all the reimbursement procedures and transmission of important data through medical coding. Health care setups and Medical practices usually rely on the medical billers for claim processes and reimbursements for the steady flow of revenue. This piece of article aims to provide guidance for medical billing, certification courses, billing work profile and career opportunities as well.

Medical insurance occupies a major role due to several health concerns hitting humans on the Earth. Medical billing creeps into the management and extraction of patient data about health-related issues and procedures to make a report for claiming insurance. Medical billing is of two different types like: professional billing and institutional billing.

Why to Choose Medical Billing?

It’s a best time to choose Medical Billing as career, as there are great job openings in medical billing as well as coding. Medical Billing is a potential field which is expected to grow exponentially in the coming years. Medical Billers are in great demand with the most rewarding and challenging career opportunities across the globe. Medical Billing filed is also a right path for those aspirants who are willing to opt for career change in future.

It’s no wonder to say that India has become a hub for medical billing outsourcing. Outsourcing medical data like billing or coding has become a common practice in the United States healthcare domain. In India, Medical Coding-Billing industry has already boomed providing healthcare claims and medical data transmission for major counties like USA, UK, Australia, Middle East countries. Several studies report that India is ranked as the number one outsourcing offshore destination for Medical billing for USA & Europe.

Medical billing is one of the stress-free jobs, good job timings, full or part time opportunities, work from home.

Education and Skills required in the Medical billing Career:          

Those looking to pursue their career in billing require relevant Bachelors or Master’s degree and certification if required. Medical Billers and coders must have an understanding of medical terminology, laws and ethics related to health insurance, medical billing and the Health Insurance Portability and Accountability Act (HIPAA). It’s is not must to have a PG degree for the medical biller Jobs, experience with additional specialized training programs (classification systems – ICD-9, CPT, DSM-IV and HCPCS) or certification may also bring good Job opportunities.

Course Duration:

• Associate’s degree programs: Two years with general education curriculum.
• Certificate and diploma programs take around a year time.
• Bachelors Program: Four years of time period.

Organizations like National Healthcareer Association (NHA), National Center for Competency Testing (NCCT), American Health Information Management Association (AHIMA), Registered Health Information Administrator (RHIA) and The American Academy of Professional Coders (AAPC), etc. offer certifications and conducts exams for crediting certifications. Few of the courses include as below:

Certified Courses:

• Certified Professional Coder (CPC)
• Certified Professional Biller (CPB)
• Certified Professional Medical Auditor (CPMA)
• Certified Documentation Expert Outpatient (CDEO)
• Certified Professional Compliance Officer (CPCO)
• Certified Physician Practice Manager (CPPM)
• Instructor Certification

Certifications would make you expert in the subject, to learn more about medical terminology, international codes, insurance types, medical billing regulations, claim procedures. It would be an additional eligibility though not mandatory.

Accreditations: Always chose medical billing training from the recognized bodies and make sure they are accredited by official or authorized bodies like American Health Information Management Association (AHIMA), Commission on Accreditation of Allied Health Education Programs (CAAHEP) and other Regional accrediting bodies. Certification from such accredited bodies will only add value to your career growth.

What Medical Billers do?

Medical billers are responsible for the timely submission of technical or professional medical claims to insurance companies from hospitals, physician offices, nursing homes or other healthcare facilities. Medical data storage includes all particulars about the patients, medical diagnosis, treatment procedures, chart details, insurance plans, claims data submission, doctor’s remarks, billing, account information and settlement records.

Medical Billers process the medical services provided to patients and then submit claims to respective insurance companies. Medical billers are responsible for the whole process till the completion of claim settlement. Medical practices and healthcare facilities and insurance companies rely on medical billers to follow billing claims and reimbursements for a steady stream of revenue.

Medical billers are also designated by roles such as hospital billers, accounts receivable billers, billing specialists, medical biller clerk, medical billing specialists, medical billing supervisor, medical records coders, medical collectors and patient account representatives, etc.

Duties of Medical Biller include:

• Patient data Registration: Complete information of Patient (Identity details, contact information, insurance details, medical history and medical reports) and need to be registered successfully, missing information can be collected from patients.
• Patients Insurance Verification: A proper review need to be done on patient’s insurance eligibility, coverage, other referrals and applicable benefits.
• Medical Coding or Transcription: Patient disease, symptoms, diagnosis, medical procedures coding can be done by Medical coders with specific alpha numeric coding (Accurate CPT, ICD, HCPCS Codes).
• Coding Compliance Checking:  Cross checking codes given to the patient data and need to ensure the data and codes entered are correct.
• Demo Entry: This step includes the entry of patient demographic information (patient’s name, gender, date of birth, place, contact number, email, address, marital status, etc.) and insurance plan into the system at the billing office.
• Charge Entry: Patient accounts need to be created and the coded documents need to be sent to charge entry department. Charges need to be entered accordingly for the medical procedures, and services provided.
• Billing Data: All the billing data need to be entered to billing software’s following specific guidelines (i.e., medical billing codes), Data is saved both in soft copies and hard copies as well.
• Claim Submission: All the created medical documents are sent to the insurance payer for payment. Claim submission has several guidelines to be followed.
• Payment Posting: This step of payment posting is one of key process involved in Medical billing which generates accounting to the handle or view patient bills. The amount billed to the patient will be adjusted accordingly by the payment status from insurance payers.
• Follow Ups: Maintain a tracking of payments, monitoring late payments, payment timelines, and initiation of notices or follow-ups to late payments.
• Reimbursements and Final Settlements: In this stage, expert medical billing team follows up with the insurers and payment agencies for the final bill settlement or the reimbursement.
• Denial Management: The submitted claims will be checked for any errors in the documents provided. Every detail will be cross checked thoroughly and final approval will be given. Any mismatch details or missing documents or codes will not be given approval at clearing house. The rejected claims will not be moved into further steps of approvals by the insurance company.
• Complaints Management: Responding timely and properly the concerns or queries from patients as well as insurance companies. Need to answer all the raised questions with a proper solution. Financial discrepancies need to be monitored well.
• Billing Records & Confidentiality: All the billing files need to be documented or recorded properly with all the updated information. Patient information need to be maintained confidentially.
• Medical billers need to clearly update and review all accounts to keep track record of payments up-to-date.
• On a final note, Medical Biller is responsible for calculating medical expenses or bills and collecting payments for those medical services provided to patients.
• Medical biller needs to have the ability to multitask when needed and manage time effectively.

Sounds pretty job description, right? Other medical biller responsibilities include, clarifying any discrepancies, scheduling and arranging payment plans for patients, obtaining prior approvals for specified procedures if required, reviewing medical bills.

Where do Medical Billers work?

Medical billers work is necessary at various sources like hospitals, physicians’ offices, clinics, health care settings, insurance companies, medical data, medical transcription, coding and billing companies, law and government bodies, educational institutions (training purpose). Expert medical billers chose to work from home.

There are different types of medical billing companies: small-scale medical billing services, professional medical billing business and physician practice management company based on the volume of the data and financial budget.

Career Outlook:

The outlook for a career in medical billing is expected to be good over the coming years. India is growing out to be a healthcare hub in terms of outsourcing. Medical Billing can be a career option for any graduates with or without higher degrees.

India is standing as a leader for being the best offshore medical billing destination and so lots of opportunities arises for the medical billers. India is chosen for its advantages in Medical billing outsourcing that include: cost effective being number one, expert and professional service, availability round the clock, quality of deliverables, no language barrier (English), and data security.

One can find suitable jobs in medical billing and also can startup to outsource medical billing service.

Setting Up Medical Billing Service:

Medical billers can also work from home option. To work comfort from home, they can opt flexible home-based career in medical billing or can also setup their own business. Medical billing service business can be also an option to earn in the field operating from a more comfort zone. All the legal notes should be considered for the works opted, to avoid being trapped. One can start own business from roots or can also buy an already existing medical billing business to easily find the grip into business.

Freelance Offers:

Also, Independent medical billing experts have the option to choose freelance projects. Working hours and work location can be as per the choice. Medical billing career offers opportunity to earn better income for those staying at home after education, busy with home affairs and family priorities. Many online Job portals post relevant posts on hiring medical billing expert to review the medical services.

Salary Expectations for Medical Billing:

A medical biller’s earning potential varies depending on where they live, work, how much they work, education, certifications, and their experience. American Academy of Professional Coders conducts an annual survey on salary trends in medical coding and billing fields. US Bureau of Labor Statistics (BLS) categorized medical billers into the role of medical records and health information technicians. Year by year, salary growth shows a higher rate of increase. There is a trending increase of average salary with experience, updated technical knowledge and required skills. The salary is also dependent on factors like location, facility size, work hours, and other factors.

Perfect Resume-Career in Medical Billing:

Building a perfect resume fetches good chances to explore opportunities. Always a resume should depict the best in you including apt career objective-briefing an overview of experience and skills, summary of qualifications, relevant work experience-highlighting medical billing experience, technical skills, other important skills, and expertise, certifications, affiliations (if any) and references. A resume should also contain three to four sentences regarding personal introduction, and potentials that the benefit the hiring company.  The resume needs to be different for different job applicants in medical billing, it differs with the freshers, experienced and looking for managerial position. It is always required to present a compelling resume that convinces employers that you have the desired qualifications, experience and skills they are looking for the current job position recruitment.

Have a glance through the below list of Medical Billing companies in major countries and India: Medusind, Elite Offshore resources, Pivotal MD, Omega, Ecare India Pvt. Ltd., Ascent Business Solutions, Allzone Management Solutions, Eminence Healthcare Services, DME/HME Medical billers, HealthQuist, HealthQuist, QWay Health, Medryte, Omni Medical Billing Service, Medphine, Curemd, Advancedmd, 4dglobal, Omegahms, Della, Access healthcare, Outsource2india, P3 Healthcare Solutions, MocDoc, Bikham Healthcare, Voxdoc, GreenPoint Healthcare, United health group, Pacific- Global BPO, Magnet Medical Coding Solutions, GroupOne, GeBBS, Vee Bill, Nissi Billing, AllZone Management Solutions, Medisweans, Penta IT Services Private Limited, etc.

Training on Medical Billing:

It’s a herculean task to choose best training center for any courses, the same applies to medical billing courses too. Always a best medical billing training requires quality school or institute with academic knowledge, practical knowledge and most importantly updated technologies. It would be beneficial for career beginners, if the training allows externship in healthcare facilities, hospitals, etc. Medical billing courses includes all the syllabus ranging from basic computer knowledge, medical terminology, physiology, anatomy, billing software’s, insurance topics. Every training program will differ with other in terms of teaching modules and syllabus.

A Perfect Career Guide – PKC:

What’s better for next step? Many questions striking, Tired of web searches, lack of requisite skills, limited knowledge, uncertain career plans and what not? Put a Full stop to all your worries and confusion in moving through the smoother career path. Here comes an ultimate solution and a perfect guide “Pharma Knowledge Centre (PKC). Right form selecting your course to making you ready for the Industry, it’s all in the hands on PKC. Services offered by PKC include exclusive training, high end consultancy, accurate recruitment-placement, enterprise review,

If you have any questions or queries about medical billing career, please feel free to contact us by email: info@pharmaknowledgecentre.com or simply call PKC on +91 8318127735. You’ll definitely find answers to all your questions. Hope you land well in the desired field and position.

Happy Billing Experience with best medical billing career ahead. Medical Billing can surely bring ultimate career settlement jobs.

References

1. https://www.aapc.com/medical-billing/medical-billing.aspx
2. https://www.medicalbillingandcoding.org/billing-process/
3. https://en.wikipedia.org/wiki/Medical_billing
4. http://www.mb-guide.org/medical-billing-process2.html
5. bls.gov
6. https://www.aapc.com/medical-coding/medical-coding.aspx
7. https://www.medicalbillingandcoding.org/qnas/how-long-does-it-take-to-complete-training-to-become-a-medical-biller-or-coder/
8. https://www.aapc.com/certification/cpb/
9. https://work.chron.com/medical-biller-do-9564.html
10. https://www.carecloud.com/continuum/why-payment-posting-is-important-in-the-medical-billing-process/
11. https://www.allalliedhealthschools.com/medical-billing-coding/medical-coding-career-reasons/
12. http://www.billingsavi.com/blog/how-to-improve-your-medical-billing-process/
13. https://www.ncbi.nlm.nih.gov/books/NBK53906/
14. https://www.aapc.com/medical-coding/medical-coding.aspx#FreeMedicalCodingTools
15. https://www.mtbc.com/learningcenter/choose-right-medical-billing-company/
16. https://www.curemd.com/medical-billing-companies-reviews/
17. https://www.consumer.ftc.gov/articles/0174-home-medical-billing-businesses
18. https://www.aapc.com/blog/40754-2017-salary-survey-right-money/
19. https://bestresumeobjectiveexamples.com/top-20-medical-billing-resume-objective-examples-you-can-use/
20. https://www.indeed.com/career-advice/resume-samples/administrative-resumes/medical-billing-specialist
21. https://www.aimseducation.edu/blog/medical-billing-coding-salaries-nj/
22. https://www.upwork.com/hire/billing-freelancers/
23. https://www.goodfirms.co/bpo/medical-billing-companies
24. https://www.business.com/categories/best-medical-billing-services/
25. https://www.businessnewsdaily.com/8693-medical-billing-services.html

Pharma Knowledge Centre – “My Learning Life” (PKC) engaged Young Indian Youths to prepare this presentation/Blog and the same has been prepared by one of the associated youngsters in consultation with PKC.

All rights reserved. All copyright in this presentation and related works is solely and exclusively owned by PKC. The same may not be reproduced, wholly or in part in any material form (including photocopying or storing it in any medium by electronic means and whether or not transiently or incidentally to some other use of this presentation), modified or in any manner communicated to any third party except with the written approval of PKC.

This presentation is for information purposes only. While due care has been taken during the compilation of this presentation to ensure that the information is accurate to the best of associate and PKC’s knowledge and belief, the content is not to be construed in any manner whatsoever as a substitute for professional advice.

Associate and PKC neither recommend nor endorse any specific products or services that may have been mentioned in this presentation and nor do they assume any liability or responsibility for the outcome of decisions taken as a result of any reliance placed on this presentation.

Neither any associate nor PKC shall be liable for any direct or indirect damages that may arise due to any act or omission on the part of the user due to any reliance placed or guidance is taken from any portion of this presentation.

The post What’s Medical Billing? Ways to Get Started in Medical Billing. appeared first on Pharma Knowledge Centre.

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Medical coding is a system containing number and letter labels that are unique for each diagnosis, symptoms, and cause of death in human beings. Medical coding aids to summarize complicated medical reports into efficient, data-friendly codes. Coding usually permits uniform documentation between medical and health care facilities.

In Present scenario, Medical coding is a fast-growing industry having great demand and offering good Job opportunities. According to the report stated by U.S. Bureau of Labor Statistics, Job positions for the certified medical coders will increase by 22 percent through the year 2022.

Who are Medical Coders?

A medical coder is a professional whose main responsibility is to translate the services provided during a patient’s visit. A medical coder reviews the report and extracts relevant information from it to assign the proper numeric or alphanumeric codes based on the documentation.

Before we enter the matter of medical coder’s role, it’s necessary to have a thorough understanding of medical coding history. Medical coding and documentation of records tracked back in crude form way back from almost 17th century. From England to all the countries it is now rapidly evolved during the past few decades. According to the New York Times – first medical coding system was introduced by French physician and statistician Jacques Bertillon in the late 1800s known as Bertillon Classification of Causes of Death which was used to classify and track mortality.

Medical coders are aware of human anatomy, physiology, medical procedures, and the payer rules and claim policies. Medical coders take the medical reports from doctors, that may include the patient’s disease condition, diagnosis, a prescription, and medical procedures suggested by the doctor or healthcare provider performed on the patient, and translate into a set of codes making up a crucial part of the medical claim. Medical coding also allows for uniform documentation between various medical facilities.

Medical coding involves codes such as CPT, ICD, HCPCS, DRG and modifiers. These codes are important for communication in describing the medical procedures and medical billing purposes. Medical Coding is also equally important in medical claims.

Why is Coding Necessary?

Why do we code medical reports? Let’s start answering the question. Medical coding is an important component and a powerful tool in the medical facilities and health care industry worldwide.

Medical coding plays a key role in modern healthcare operations for patient safety, accuracy and fast billing process, documentation purpose, maintain patient confidentiality and other required efficient operations. Medical coding collects information about disease diagnosis, treatment methods, medications and necessary equipment and then translates them into relevant alphanumeric codes. Medical coding is an important step required to submit medical claims with insurers and bills for insurers and patients.

Coding is also critical for demographic and statistical analysis of disease prevalence, diagnosis, treatment outcome.

 Types of Codes, You Must Know!

There are three sets of code which are used by medical coders on daily basis. Let us briefly look into those codes:

• ICD codes

ICD Codes are the International Classification of Diseases codes. ICD-10 is the tenth version of which is currently in use. ICD codes are usually in use by doctors, and other healthcare providers to classify and code all diagnoses, symptoms and procedures recorded in conjunction with hospital care. These ICD Codes provide detailed information of diagnostic specificity and morbidity classification.

• CPT

CPT refers to Current Procedural Terminology Code which is used to report medical, surgical, and procedural code to the entities such as health insurance companies or organizations. They are used in with relevance to ICD-10 during electrical medical process. It is divided into 3 subcategories:

• HCPCS

HCPCS is known as Healthcare Common Procedure Coding System and is the official code for certain hospital outpatient care, chemo drugs and other medical services or procedures. HCPCS Codes include reliable medical devices, prosthetics, ambulance rides, and certain medications or drugs.

The HCPCS code set is divided into two levels. Level I is identical to the CPT codes and Level II is a set of alphanumeric codes that is again divided into 17 sections, each based on an area of specificity like medical and clinical laboratory or rehabilitative services.

Just like CPT codes, each HCPCS code should correspond with a diagnostic code that equally justifies the medical procedure. It is the ultimate responsibility of coder to make sure whatever outpatient procedure is detailed in the doctor’s report makes sense with the listed diagnosis, typically described through an ICD code.

Now that you’ve got a better idea of medical coding types of codes, and what does a medical coder do? Let’s start exploring the importance of certified coding professionals.

Who hires medical coders?

Almost all the health care providers like hospitals, clinics, nursing homes, insurance agencies, and other health facility organizations use coded documentation and records by qualified medical coders. Employers usually prefer to hire CPC certified candidates. Hence medical coders need to grab the opportunity in the corporate side of healthcare earning medical coding and billing certification to cope up with the competitive edge in the current job market. Certification assures employers in choosing right candidate having professional skills and qualifications perform his or her duties well. Let’s get a great start with certified professional coding to flourish in medical coding field.

Certified Professional Coder (CPC®)

A certified professional coder, in short CPC is responsible for overseeing the medical coding process. Medical coders make sure that the coding used is in compliance with all medical coding laws and regulations and also ensure that the coding aids reimbursable expenses when required. Medical coders provide health care agencies with regular coding, surgical coding, or hospital coding or others as per the requirement. Coders may also sometimes effectively communicate with patients, doctors and other staff regarding claim procedures or rejections.

Medical coding certification can improve an applicant’s chance at landing a job and can usually enjoy better pay, job security and competency in the field. In order to become certified, medical coding professionals must demonstrate thorough knowledge on medical codes.

Medical coders need to have appropriate knowledge on coding and insurance rules and regulations, documentation skills, communication and interactive skills, computer knowledge and must maintain confidentiality. Above all, medical coders need to be certified for medical coding along with the specified degree. Experience may also be an added advantage in the field to prove you as a proficient coder.

The most common medical coding programs are Certified Professional Coder (CPC), the Certified Coding Specialist (CCS) and the Certified Medical Coder (CMC). Medical students can hurry up to earn your Certified Professional Coder credential, the most recognized and standard medical coding certification in the healthcare industry settings. Medical coding certification is available through different organizations. The right certification for any medical coder ultimately depends on a candidate’s relevant experience and intended specialization. There are institutes and certification programs in Medical Coding to pursue that match their goal of becoming certified professional medical coder.

Certified professional medical coders must demonstrate a strong understanding of following knowledge criteria:

• Appropriate knowledge on Human Anatomy and Human Physiology and disease processes through education.
• Well versed with the Medical Procedures, the rules and regulations that define how to code them in health records and insurance claims.
• Medical Terminology: including evaluation and management, surgery, anesthesia, radiology and pathology.
• Medical Coding guidelines, rules & regulations.
• Payment rules, insurance billing and claim- reimbursement policies.
• Sound knowledge on various types of medical codes: CPT, HCPCS Level II, and ICD-9-CM Volume 1-2 medical codes.
• The ability to translate health care provider notes into accurate code, assignment of accurate medical codes for medical procedures, services and diagnoses.
• Possess problem solving techniques and skills in dealing with queries to ensure medical proper coding.
• Handle complex issues related to medical necessity, claim denials, bundling issues, and charge capture.
• Interactive and good communication skills can be helpful to engage in the difficult task of explanation to patients regarding a specific claim rejection.

How to Earn CPC Certification?

Earning most recognized CPC credential increases job opportunities. This article intends to brief up the procedure to earn CPC certification in simple steps.

CPC Exam – Certified Professional Coder exam is conducted by American the American Academy of Professional Coders (AAPC). One must take CPC exam which covers syllabus of 24 different areas including medical terminology, anatomy, physiology, diseases – diagnostic codes, coding guidelines and specific medical coding. This CPC Exam consists of 150 multiple choice questions with a time limit of five hours and 40 minutes. One must answer at least 70 percent of the questions correctly to pass the CPC exam. Well prepared candidates can get through the exam for being certified.

CPC Certification:  CPC Certification is awarded by AAPC for those who have passed CPC exam and having membership.  The job is not over if certification is done, we need to maintain our certification through AAPC-approved continuing education units called CEUs. Membership must be renewed annually by the members. Also, for the renewal, members need a current membership if applying for the exam or waiting for results.

On-Job Experience: To obtain a CPC credential, one must have spent two years of working experience with CPT, ICD and HCPCS codes – or need to submit a proof of 80 hours of coding education.

Engage in ongoing Education:  Updating with the current healthcare technology and regulation changes would fetch better opportunities. You must submit 36 CEUs (36 hours of continuing education) every two years for certificate validation. CE units earning opportunities are available through AAPC.

If you do not initially meet this required qualification, you’ll receive a CPC-A® (apprentice) designation, until the required experience is achieved.

Benefits of Medical Coding Career

Take the first step toward your Medical Coder Career with the below benefits

• High demand career option.
• Work from home
• Job having flexible timings.
• Easy access of job availability.
• Best Compensation.
• Saving life.

Keep reading our latest updates on medical career, to take a closer look at this growing phase for best knowledge source. Browse Pharma Knowledge Centre to get started with finding the medical coder certified program that meets your needs, goal preferences, and career. Here at PKC, you’ll find directive information on medical coding and billing certified professional course, career paths and job options.

At PKC, Training is provided on Medical codes, Legal Amendments, Regulatory changes, Local and National Trends in Coding and Soft Skills Development. Classes are scheduled accordingly, so chances are high to start your course soon. Job placement assistance is also available for the easy landing in the field.

Boost your Medical Coding Career with Best Options

Medical coding certification is a badge of right skills and quality experience as many employers usually prefer to hire candidates with certification. Hence, earning your medical coding certification gives you a competitive edge in the current job market. Once you are set with certification, experience in the field that would be enough to boost your career.

American Academy of Professional Coder (AAPC) was created to provide professional development and standards for the medical coding industry. Through the AAPC, medical coders can receive documented certifications indicating their subject knowledge and understanding analysis of medical coding, billing, medical auditing and medical compliance.

Career paths for successful CPCs

Medical coding or management require more expertise and on job experience with high package salaries. Currently the average certified professional coder salary is rising, and this would be a great time to enter the coding field. Especially for doctors or medicos, who want to move into management other than clinical setting, there are plenty of options available.

Tired of searching the best guide, Industry experienced- certified trainer and job placement assistance for career growth in medical coding field, end your search here at Pharma Knowledge Centre. This would be a good choice to visit before you make any binding decisions about your medical career and best placements. PKC offers trustworthy and customized resources (training, consultancy support, advisory panel, recruitment, workshops) to the aspirants (Doctors, Pharma graduates, life science graduates, medical transcriptionists) towards becoming a medical coder.

References:

1. aapc.com
2. World Health Organization, History of the development of the ICD. https://www.who.int/classifications/icd/en/HistoryOfICD.pdf
3. American Association of Professional Coders (AAPC), What is Medical Coding? https://www.aapc.com/medical-coding/medical-coding.aspx\
4. Bureau of Labor Statistics, U.S. Department of Labor, Occupational Outlook Handbook. bls.gov/ooh
5. https://www.aapc.com/certification/cpc/
6. ahima.org
7. https://www.medicalbillingandcoding.org/coding-training/
8. https://www.allalliedhealthschools.com/medical-billing-coding/medical-billing-and-coding-certification/
9. http://www.a16coding.com/
10. https://www.medicaltechnologyschools.com/medical-coder/medical-coding-certification-guide
11. https://www.verywellhealth.com/the-basics-of-medical-coding-2317075
12. https://www.medicalbillingandcoding.org/learn-more-about-coding/
13. https://www.acponline.org/practice-resources/business-resources/coding
14. https://www.aapc.com/medical-coding/medical-coding.aspx
15. https://www.beckershospitalreview.com/finance/8-most-common-coding-errors.html
16. https://www.beckershospitalreview.com/finance/15-things-to-know-about-medical-coding.html
17. https://www.allalliedhealthschools.com/medical-billing-coding/medical-coding-career-reasons/
18. https://www.rasmussen.edu/degrees/health-sciences/blog/what-is-medical-coder/
19. https://explorehealthcareers.org/career/allied-health-professions/medical-coder/

Pharma Knowledge Centre – “My Learning Life” (PKC) engaged Young Indian Youths to prepare this presentation/Blog and the same has been prepared by one of the associated youngsters in consultation with PKC.

All rights reserved. All copyright in this presentation and related works is solely and exclusively owned by PKC. The same may not be reproduced, wholly or in part in any material form (including photocopying or storing it in any medium by electronic means and whether or not transiently or incidentally to some other use of this presentation), modified or in any manner communicated to any third party except with the written approval of PKC.

This presentation is for information purposes only. While due care has been taken during the compilation of this presentation to ensure that the information is accurate to the best of associate and PKC’s knowledge and belief, the content is not to be construed in any manner whatsoever as a substitute for professional advice.

Associate and PKC neither recommend nor endorse any specific products or services that may have been mentioned in this presentation and nor do they assume any liability or responsibility for the outcome of decisions taken as a result of any reliance placed on this presentation.

Neither any associate nor PKC shall be liable for any direct or indirect damages that may arise due to any act or omission on the part of the user due to any reliance placed or guidance is taken from any portion of this presentation.

The post What is all about Medical Coding with CPC Certification? appeared first on Pharma Knowledge Centre.

The term ‘GMP’ is well identified worldwide for the quality control and management of manufacturing and quality testing of pharmaceutical products. There is also another term into existence called cGMP (Current Good Manufacturing Practices). cGMP with its nomenclature reminds most of the companies to comply with updated regulations.

Above all, pharmaceutical manufacturers must not place patients at risk due to inadequate safety, quality or efficacy that outline the aspects of production and testing that can impact the quality of a product.

Why is GMP Important?

Pharmaceutical quality is of vital importance for safety of life. Hence, several regulations are made mandatory, one such key is GMP.

For instance, just imagine getting a prescribed drug from the pharmacy and hoping the best for the drug to work and get well soon. You may have no idea on the quality of efficacy of the drug, but GMP regulations includes all those what patient needs for using the drugs including below:

• Label on the Drug
• Safe for human consumption
• Drug Efficacy
• Use by or Expiry Date
• Correct Dosage
• Quality Tested
• Contaminated with microbes (if any such)

In Today’s World, GMP is established to regulate the standard quality of pharmaceuticals and other medical products. GMP lies at the heart of Pharma Industries. GMP has gained much importance as they are guidelines which are especially enacted to ensure quality and safety in the production of food, drugs, cosmetics, medical diagnostics and devices. These GMP regulations, enforced by the Food and Drug Administration, help reduce the instances of product recalls, harmful effects and eventual lawsuits that may arise from defective products.

But, why do we actually need the GMPs? Shouldn’t we (individuals, companies) simply and strictly follow Quality control regulations and be able to figure out any errors during production of pharmaceutical drugs medical devices thereby yielding safe and effective products. Yes, Of course, Good quality must be implemented during the manufacturing process, but it cannot be testing tool for the final product. GMP checks all the errors that cannot be however eliminated through quality control of the finished product. GMPs are claimed to be standard legal regulations which protects the consumer from purchasing a product which is not effective or even dangerous. Failure of pharmaceutical firms to comply with GMP regulations can result in very serious risky outcomes.

This blog highlights the importance of GMP in Pharma industry, bringing out the best information to the students aspiring to begin their career in Pharma.

Merits of GMP

GMP exists mainly to protect the health and safety of patients or consumers. Do you wonder what would be the benefits of GMP?

GMP takes the credits of following benefits.

1. Evidence of safe and efficient product.
2. Compliance with legal requirements.
3. Increases consumer confidence and trust buildup in your products.
4. Reduction of product claims, returns, reprocesses and rejections.
5. GMP helps boost export opportunities.
6. Cost saving benefit.

Demerits without GMP:

• Unexpected product contamination
• Causing damage to health or even death
• Labeling Errors
• Ingredients Composition

Who Need GMP?

GMP is required by the Pharmaceuticals industries, Biotech companies, Bulk drug API manufactures, Formulators and Food Processors, Manufacturers of Medical devices, cosmetics and other life-science industries.

GMP is incorporated by more than 100 countries into their medicine’s laws, and also many more other countries have adopted their own GMP requirements. However, WHO-GMP stands as a basis for the WHO Certification Scheme and prequalification of vaccines.

In general, Pharmaceutical firms and biotechnology companies follow GMPs to ensure their products are manufactured adhering to specific requirements like identity, strength, quality, purity, efficacy and safety.  Compliance is regulated by the Food and Drug Administration (FDA).

Topics included in GMP and following regulations in below areas of Pharma industry.

• Area or Location: Buildings and Facilities.
• Equipment: Maintenance of equipment, cleaning, calibration and validation.
• GMP Validation.
• Production and In-process controls.
• Production Materials: Proper management.
• Packaging and Labeling of Products.
• Laboratory Controls.
• Personnel: Qualification, Safety and Responsibilities.
• Complaints and Recalls.
• Change Control.
• Computer Systems and Information Technology.
• Quality Assurance and Quality Control.
• Documentation and record keeping of GMP procedures.
• Drug Product Regulations.

Low standard quality medicines are not only a health hazard, but a waste of money for both governments and also individual consumers, it may also lead to shortage of drugs. GMP regulates all such quality issues of medical products and hence GMP is currently very crucial. The majority of countries accept the import and sale of medicines that have been manufactured to internationally recognized GMP standards.

Individuals looking for a new challenge in the pharmaceutical quality field, with keen interest entering demand career path, simply go through the training programs available through Pharma Knowledge Centre. Here in the training offered, you can learn everything about good manufacturing practices which you’ll definitely need to make a smooth transition into your career path. PKC is offering a best opportunity in the Pharma industry to get certified for becoming a GMP Professional.

Pharma Knowledge Centre is designed to help Pharma graduates to understand the basics on Good Manufacturing Practice with the Practice course for students including Hand’s on training. Contact the PKC team to get started today to become an expert in Good Manufacturing Practice. The knowledge provided by PKC is intended to guide students entering into Pharma industries.

Topics covered in syllabus of PKC GMP Training include: Brief about Pharma Companies, GMP History and GMP Requirements, Work flow, Production Management, etc.

The GMP training program of PKC has been designed in a way so as to compliment the basic education and judge the job opportunities in providing a platform for Life Science and Pharmaceutical professionals to enter Pharma and biotech industry. In this GMP program, there is a great scope to learn and acquire specialized knowledge and most importantly practical skills required to function personnel in various arenas like pharmaceutical, biotechnology, medical device, food, cosmetics, and also other associated life-science industries.

References     

1. https://www.fda.gov/drugs/pharmaceutical-quality-resources/facts-about-current-good-manufacturing-practices-cgmps
2. https://ec.europa.eu/health/documents/eudralex/vol-4_en
3. https://www.who.int/medicines/areas/quality_safety/quality_assurance/gmp/en/
4. https://ispe.org/initiatives/regulatory-resources/gmp/what-is-gmp
5. https://asq.org/cert/pharmaceutical-gmp
6. Chaloner-Larsson, Gillian, Anderson, Roger, Egan, Anik, Da Fonseca Costa Filho, Manoel Antonio, Gomez Herrera, Jorge F. et al. (‎1999)‎. A WHO guide to good manufacturing practice (‎GMP)‎ requirements.
7. fda.gov./cder/guidance/index.htm
8. https://www.sciencedirect.com/science/article/pii/S1319016413000753
9. https://www.fda.gov/drugs/pharmaceutical-quality-resources/facts-about-current-good-manufacturing-practices-cgmps
10. https://www.thebalancesmb.com/introduction-to-current-good-manufacturing-practices-cgmp-2221107
11. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3122044/

Pharma Knowledge Centre – “My Learning Life” (PKC) engaged Young Indian Youths to prepare this presentation/Blog and the same has been prepared by one of the associated youngsters in consultation with PKC.

All rights reserved. All copyright in this presentation and related works is solely and exclusively owned by PKC. The same may not be reproduced, wholly or in part in any material form (including photocopying or storing it in any medium by electronic means and whether or not transiently or incidentally to some other use of this presentation), modified or in any manner communicated to any third party except with the written approval of PKC.

This presentation is for information purposes only. While due care has been taken during the compilation of this presentation to ensure that the information is accurate to the best of associate and PKC’s knowledge and belief, the content is not to be construed in any manner whatsoever as a substitute for professional advice.

Associate and PKC neither recommend nor endorse any specific products or services that may have been mentioned in this presentation and nor do they assume any liability or responsibility for the outcome of decisions taken as a result of any reliance placed on this presentation.

Neither any associate nor PKC shall be liable for any direct or indirect damages that may arise due to any act or omission on the part of the user due to any reliance placed or guidance is taken from any portion of this presentation.

The post GMP, A Crucial Figure of Pharma Industry appeared first on Pharma Knowledge Centre.

To List out few major issues faced of Pharmacists would be like:

1. Dispensing Controlled Substances to Addicts.
In Day to day activities of a pharmacist, they come across many patients on regular basis. But Pharmacists need to be alert in dealing with those who are drug addicts. This would be a tough task and need to be very alert in dispensing medicines to such drug addicts. Pharmacists are most importantly reminded of the importance of checking the prescription and identity of the doctor before making dispensing a prescription only medicine. Pharmacists are strongly advised to screen patients for possible signs of drug misuse.

2. Professional Responsibility by Pursuing a Higher Education, Training & Certification.
Higher Education is necessary in every field of today’s World. Pharmacy education provides training in medical field, deep understanding of drugs, and treatments for medical health issues, to serve patients with expert advice regarding medication. Pharmacy Education requires a longer period of study, number of clinical hours and pass series of examinations and above all lot of financial support.

As Pharmacists are expected to handle high end professional responsibilities, they need to be sound in knowledge and hence are required to pursue higher education through Pharmacy colleges. Pharmacists along with education need to have a legal licensed issued by Govt. body of the State.

3. Staying up-to Date in Pharmacy
Pharmacist need to be an all-rounder in terms of acquiring novel technologies and persistent changes in the pharmaceutical industry. Being into Pharmacy profession is not a one-time achievement it however requires lifelong commitment. It is very essential for a pharmacist to stay updated with the latest pharmacy practices, new drugs in market, pharmacy laws and trends followed in industry for better service to the patients.

4. Impact of Personal and Religious Differences.
Coming to the context of personal and religious beliefs, religious principles should not interfere with the health care. Pharmacist main motto need to ensure a patient-centred care without being altered while offering certain treatments like emergency hormonal or routine contraception (fertility medicines). Also, Pharmacists must be able to keep track of medicines that are not accepted by certain religious communities. For Instance, Patients from Jewish and Muslim communities are against using medicines derived from animal sources like pigs. So, Pharmacists also need to investigate such is issues to avoid unnecessary problems.

5. Change in Demographics.
According to the United Nations report, the world’s population is expected to increase by one billion people by the year 2025. Changing demographics demand new approach in healthcare systems. Pharmacists need to understand the change in demographics to adapt pharmacy products. With the increase in population, different complications arise and alterations in medicine usage may be outdated now. Medicine approach needs to be followed as per the age and different groups of population as different medicines affect people differently.

Need not worry for the issues, Come on look into the innovative insights or solutions into the Profession with simple knowledge. Combat the issues or challenges with ease. Pharmacists need to be considered as health care providers by the Public community and Pharmacists need to provide valued customer service to the community.
Follow simple insights in to the job for being treated as an accessible professional member who is integrated into the health care system.

• Pharmacists need to analyze the very basic difference between professionalism and commercialism to balance both gaining mutual benefits.
• Always staying updated with the current knowledge and latest technologies.
• Direct and effective customer interactions and improving engagements along with the proper follow up to increase benefit to the patients.
• Maintaining medication supply standards as per the law, customer service satisfaction and conduction of surveys.
• Following standard fee based on medication supply and on the cost of the service.

Conclusion
Pharmacists also go beyond the Pharmacy counter playing a vital role providing improving access to health care. Facts include that Pharmacists provide drug dispensing, medication supply an information, medication counseling, disease management education, vaccination services and connecting through electronic health care records. For any skill enhancement related to Pharmaceutical or Healthcare related skill gap, Pharma Knowledge Centre plays crucial role for both fresher’s and industry professional to achieve the skilling required as per current Industry standards.
Because in the coming future, the pharmacists need to be ready to respond in proactive way as real champions of the public health community. Pharmacists need to apply latest trends of medical technology into work flow, and would be partner in health for the community.

References

• Kehrer JP, Eberhart G, Wing M, Horon K. Pharmacy’s role in a modern health continuum. Can Pharm J (Ott). 146(6):321-324.
• The Pharmaceutical Journal, September 2000, online | URI: 20003038
• https://vaccine-safety-training.org/vaccine-preventable-diseases.html
•  https://www.cdc.gov/vaccines/vpd/index.html

Pharma Knowledge Centre – “My Learning Life” (PKC) engaged Young Indian Youths to prepare this presentation/Blog and the same has been prepared by one of the associated youngsters in consultation with PKC.

All rights reserved. All copyright in this presentation and related works is solely and exclusively owned by PKC.

The same may not be reproduced, wholly or in part in any material form (including photocopying or storing it in any medium by electronic means and whether or not transiently or incidentally to some other use of this presentation), modified or in any manner communicated to any third party except with the written approval of PKC.

This presentation is for information purposes only. While due care has been taken during the compilation of this presentation to ensure that the information is accurate to the best of associate and PKC’s knowledge and belief, the content is not to be construed in any manner whatsoever as a substitute for professional advice.

Associate and PKC neither recommend nor endorse any specific products or services that may have been mentioned in this presentation and nor do they assume any liability or responsibility for the outcome of decisions taken as a result of any reliance placed on this presentation.

Neither any associate nor PKC shall be liable for any direct or indirect damages that may arise due to any act or omission on the part of the user due to any reliance placed or guidance is taken from any portion of this presentation.

The post Counsel Me: You’ll get some insights into issues you may face while working as a pharmacist. appeared first on Pharma Knowledge Centre.

Millennials, also known as Generation Y or the Net Generation, are the demographic cohort that directly follows Generation X. The term Millennials is usually considered to apply to individuals who reached adulthood around the turn of the 21st century. This is the generation that grew up in an electronics-filled and increasingly online and socially-networked world. These are the generation that has received the most marketing attention. As the most ethnically diverse generation, Millennials tend to be tolerant of difference. Having been raised under the mantra “follow your dreams” and being told they were special; they tend to be confident.

Millennials grew in the computer age where technology has always been at their fingertips. From information to day-to-day activities like shopping or movies, they get it anything, anytime and anywhere using their smartphone devices. This makes them adapt to technologies and they tend to adjust readily to new programs, operating systems (OS) and devices and to perform computer-based tasks more quickly than older generations.

One reported result of Millennial optimism is entering into adulthood with unrealistic expectations, which sometimes leads to disillusionment. Many early Millennials went through post-secondary education only to find themselves employed in unrelated fields or under employed and job hopping more frequently than previous generations. Their expectations may have resulted from the very encouraging, involved and almost ever-present group of parents that became known as helicopter parents. To say that we live in a changing world understates the speed of both the pace and the scope of ongoing change. While we’re all born with an intense desire to learn, somewhere along the line many of us lose our passion for learning.

The Skills You Have and the Skills They Want

The pharmaceuticals industry has evolved greatly in terms of work management. Just like any other sector, automation and artificial intelligence (AI) is slowly creeping into most of the activities happening in the industry. This Change is inevitable because AI provides high efficiency with a high degree of reliability. Thus, it is most likely that all the repetitive tasks will soon become obsolete. Maybe the process which requires 100 to 150 employees to handle will be entirely operated with robots under the supervision of a single person.

In the modern age of technology, we cannot overlook the fact that most important skills that recruiters are looking for in a candidate today are the HR skills, also known as soft skills. To be able to communicate effectively is the basic and most necessary requirement for a healthy work culture, and a hiring manager will take all possible precautions to ensure that the person joining his company fulfils these criteria. Learning is a continuous process but it is important to have an attitude of learning. Of course, it’s not about acquiring knowledge for knowledge’s sake. We can all acquire copious amounts of knowledge just by sitting on Wikipedia all day.  Your smartphone alone gives you access to more information at your fingertips that you can process it in your entire lifetime, much less actually useful.

The Skills Companies Need Most in 2019

Strengthening a soft skill is one of the best investments you can make in your career, as they never go out of style. Plus, the rise of AI is only making soft skills increasingly important, as they are precisely the type of skills robots can’t automate.

That’s why 57% of senior leaders today say soft skills are more important than hard skills.

According to a survey conducted by LinkedIn, it turns out that professionals are keenly interested in learning new skills (which makes us deliriously happy). And learning tends to spike in January, as people start the year focused on building new habits. Here’s a list of top 5 skills that companies are looking for:

1. Creativity
2. Persuasion
3. Collaboration
4. Adaptability
5. Time Management

You may have noticed that the skills mentioned above are the ones that AI cannot perform voluntarily unless there is a highly complex algorithm applied but eventually will definitely require human intervention. A candidate with high level of emotional intelligence will be preferred over a high level of domain intelligence or hard skills.

LEARN, UNLEARN, RELEARN

It is not only the skills that we have acquired over the academics that matter, what is more important is the ability of the employee to adapt to change. Adult education experts estimate that up to 40% of what tertiary students are learning will be obsolete a decade from now when they will be working in jobs that have yet to be created. Indeed, the top 10 most in-demand jobs today didn’t even exist 10 years ago.  Today the learning needs of the industry is growing daily and there are increasing needs for innovative course developments. Inter-disciplinary studies are more preferred because only the ones with the widest skill set can survive in this highly volatile work environment. 

How to stay ahead of the curve?

Just like motivation, a positive learning attitude is difficult to develop and maintain. However, it is possible if you commit yourself to think and act positively. For example, maintaining a quality of openness would allow you to see things beyond your existing paradigms, inspire you to celebrate the joys of learning, and most important of all, empower you to take control of your learning.

The meaning you ascribe to education will serve as your driving force (motivator) in learning. Of course, from time to time depending on the situation, you may have other motives for learning. To find out more about what motivates you, ask yourself the following questions:

• Do I study solely for the purpose of getting a degree to advance my job/career prospects?
• Do I study to prove my capability through academic grades?
• Do I study to satisfy my curiosity and learn new things?

Staying motivated in your studies requires a clear purpose and positive learning attitude. It is a conscious choice that you have to make. By spending time to reflect upon what have been discussed above, you can find a perspective to learning that would give you fulfilment and pleasure in your learning experiences. It is always better to be under the guidance of mentors who continuously support and update the freshers with new and latest information. Training programs from an industrial veteran will help a job aspiring candidate to learn a lot about the job scenario and give him the opportunity to apply himself in the best possible way,

One can always learn from the experts and join various training centers running at many places all over India that bridges the gap between the Industrial needs and candidate skills by conducting various training programs. One such well known training centre is Pharma Knowledge Centre at Ahmedabad which provides hands-on training courses and industrial exposure to young and budding pharmacists so they can get better exposure to industrial scenario and train them for the future industry needs.

References:

1. Beatrice, J.A. (1995). Learning to Study through Critical Thinking. Ch. 1: ‘College Learning’. Chicago: Irwin, pp. 3–25.
2. Carter, C.; Bishop, J.; & Kravits, S.L. (2002). Keys to Effective Learning (3rd ed.). Ch. 1: ‘Becoming a Lifelong Learner’. Upper Saddle River, NJ: Prentice Hall, 16–20.
3. http://www.cdtl.nus.edu.sg/success/sl31.htm
4. https://whatis.techtarget.com/definition/millennials-millennial-generation
5. https://www.forbes.com/sites/margiewarrell/2014/02/03/learn-unlearn-and-relearn/#4e7e2bb8676f

Pharma Knowledge Centre – “My Learning Life” (PKC) engaged Young Indian Youths to prepare this presentation/Blog and the same has been prepared by one of the associated youngsters in consultation with PKC.

All rights reserved. All copyright in this presentation and related works is solely and exclusively owned by PKC. The same may not be reproduced, wholly or in part in any material form (including photocopying or storing it in any medium by electronic means and whether or not transiently or incidentally to some other use of this presentation), modified or in any manner communicated to any third party except with the written approval of PKC.

This presentation is for information purposes only. While due care has been taken during the compilation of this presentation to ensure that the information is accurate to the best of associate and PKC’s knowledge and belief, the content is not to be construed in any manner whatsoever as a substitute for professional advice.

Associate and PKC neither recommend nor endorse any specific products or services that may have been mentioned in this presentation and nor do they assume any liability or responsibility for the outcome of decisions taken as a result of any reliance placed on this presentation.

Neither any associate nor PKC shall be liable for any direct or indirect damages that may arise due to any act or omission on the part of the user due to any reliance placed or guidance is taken from any portion of this presentation.

The post Meeting the learning needs of the industry appeared first on Pharma Knowledge Centre.

With more and more pharmacy schools opening up every single year, the number of new grad pharmacists continue to grow exponentially. Unfortunately, this number does not seem to be keeping up with the growth of new pharmacist jobs available.

This chart shows the PDI (Pharmacist Demand Indicator) for the last 10 years. If the value is above 3, it indicates that there is a demand for Pharmacy students. If the number equals to 3, it indicates the supply meets the demands. Late in the year of 2017 marked for the first time a drop in PDI below 3, which indicates that there is was a shortage of pharmacist jobs. Later the scenario stabilized for the year-end.

The above data shows how the demand for fresh graduates and experienced professionals may vary according to time and the demand has been consistently decreasing in the past couple of years.

This can be majorly attributed to the fact that there are increasing number of pharmacy institutions coming up in the country hence the number of Pharma graduates keep on increasing constantly. This leads to increase in the competition and there are not enough job opportunities to accommodate all.

On the other hand, heavy workloads and long hours make stress management a critical skill for pharmacists. A study of practicing pharmacists found that more that 68% experienced job stress and role overload. Almost half reported work– home conflicts. Respondents cited role ambiguity as a serious concern—they were often unable to provide ideal professional services because mundane tasks took priority. Among the functions they perceived got short shrift was not meeting their expectations, because they lacked either time or necessary skills.

What is Stress?

Stress is the “wear and tear” our bodies experience as we adjust to our continually changing environment; it has physical and emotional effects on us and can create positive or negative influence on us. As a positive influence, stress can help compel us to action. As a negative influence, it can result in feelings of distrust, rejection, anger, and depression, which in turn can lead to health problems such as headaches, upset stomach rashes, Insomnia, ulcers, high blood pressure, heart disease, and stroke. With the death of a loved one, the birth of a child, a job promotion, or a new relationship, we experience stress as we readjust our lives. In so adjusting to different circumstances, stress will help or hinder us depending on how we react to it.

Other studies identified interpersonal interactions, level of compensation and advancement, role stress, and career commitment as stress triggers. This research found that when management improves interpersonal interactions among staff members, they become more committed to the profession. Better interactions among staff reduces nonwork conflicts – and the work environment is more manageable.

A startling 15% of pharmacists are so stressed in their current job that they have considered finding a new job – a stressful process itself – although most wish to remain in the profession.

Among all pharmacy staff, uncertainty about continuing employment, heavy workload, short staffing, and inability to update and improve professional competence are significant stressors. Staff who report highest satisfaction, lowest stress, and plans to remain on their jobs cite supervisor support and managerial flexibility as key reasons. Recall the adage, “People don’t quit their jobs, they quit their supervisors.”

Sources of stress (stressors) in the undergraduate population include financial burdens, new and increased academic demands, increased independence, and adjustment to a new environment and culture. A limited number of studies have focused on the Health-Related Quality of Life (HRQoL) and perceived stress among the pharmacy students and noted that pharmacy students experience higher levels of perceived stress and lower levels of HRQoL compared to the general population.

While both these factors are significant, it is equally important to understand the Quality of Life (QoL) of pharmacy students. There are notable differences between HRQoL and QoL as defined by the World Health Organization (WHO). While HRQoL talks about the physical, mental, and social well-being, QoL is defined as the individual’s perception of his/her position in life in the context of the culture and value systems in which he/she lives and in relation to his/her goals, expectations, standards, and concerns. The QoL adds other dimensions such as environment, spirituality, and life in general to physical, mental, and social well-being.

Key Contributing Factors of Stress Among Pharmaceutical Professionals

With a drastic increase in the number of Pharmacy colleges in almost every part of the country, the intake of pharmacy students has increased to leaps and bounds in the colleges. In aspiration of a good future, students have opted the pharmacy profession. But as their graduation comes to an end, they are now finding themselves in a state of dilemma about what they should do now because it is becoming increasingly difficult for a fresher to land a promising job in the Pharma Industry. And luckily if someone gets a job, he is bound to work in a very low salary for initial years which is even not sufficient to earn his livelihood. The other option left for the student is to go for higher education, for which again he has to pay a huge amount to the colleges.

A study conducted by Ammar Ihsan et al showed possible correlation between perceptions of stress and HRQOL among MPharm students. MPharm students reported relatively lower levels of perceived stress than non-pharmacy students; however, MPharm students reported relatively lower mental HRQOL than non-pharmacy students. In addition, higher levels of perceived stress were negatively correlated with mental and physical HRQOL.

The most common stress triggers reported by M.Pharm students were related to the curriculum (examinations, case presentations and clerkship reports).

Most students employed positive lifestyle strategies in order to alleviate stress. Strategies should be developed in order to alleviate perceived stress and to promote the mental and physical HRQOL of these students. Again, go for PhD, which has also become a money game by some of the universities offering PhD as just a degree. In this curriculum, the students doing their degrees from reputed institutes are also treated at par with the students doing degrees with such universities giving degrees just for money.

Stressors

According to a study conducted by Jennifer Beall et al, class assignments and completing electronic portfolios are the top stressors reported among student pharmacists. There was a higher percentage of female participants that selected the items in the survey as stressors compared to males in all surveyed stress trigger items but one. Males had a higher percentage of stress than females concerning completing survey(s) from faculty or administration. A majority of students perceived IPPEs as a major stressor. Tables below illustrate the stressors analyzed between genders and among age groups, respectively.

The PharmD Situation

The Pharm.D program in India can be a major support for the Indian health care system and can help to address many loop holes and issues persisting in India if utilized properly however a tough and bumpy road is ahead for the Pharm.D graduates. There are 233 colleges approved by the PCI to run Pharm.D programme in their premises so far they have produced overall 20,000 graduates and approximately 9000 are graduating each year. They are facing the challenge of getting placed after completion of their course. Though initially introduced and regulated by Pharmacy Council of India (PCI) but the programme is now being controlled by both All India Council of Technical Education (AICTE) and Pharmacy Council of India (PCI).

The profession of PharmD is facing serious lack of recognition and underutilization, especially in India.

Only handful of private hospitals are now offering job as a clinical pharmacist on low pay grade. This forces them to work in non-conventional fields such as medical writing, medical coding instead of practicing their profession due lack of opportunities in government hospitals. The course of Pharm.D is of Six years duration and is considered as a postgraduate doctoral degree. Even the fees structure for a PharmD course is much higher compared to the B.Pharm course. Students get quite frustrated due to lack of opportunities even after they dedicate six years of their precious time into training themselves.

This happens majorly due to reasons like the PharmD graduates are still not legally allowed to prescribe in India although they possess better knowledge about drugs and the possible side reactions/adverse reactions that they might cause.

The state of Hyderabad has already scraped out the course due to scarcity in job prospects after completion of the course. “The role of a Pharm D graduate is not defined unlike that of a doctor, dentist, or an engineer. It is not clear he or she can open a clinic as a pharmacist”, said N Yadaiah, registrar, Jawaharlal Nehru Technological University. He said that the students have even moved the court asking why there are very few jobs for PharmD graduates.

Paradigm Shift

In the year 2017-2018, the Pharmacy Council of India made the semester system of education mandatory for B.Pharm and M.Pharm colleges. This move was taken in order to bring a dynamic change in the pharmaceutical educational system, since the syllabi needed revision with the latest and upcoming trends in the industry. These changes came with their own advantages and disadvantages.

On the bright side, the syllabus of undergraduate and postgraduate courses in pharmacy were updated to a great extent which became a crucial part of upgradation. One key problem that the Pharmacy Council failed to address initially was to implement Continual Pharmacy Education programs (CPEs) to train the professors and lecturers before the change took place. As a result, the efficiency of deliverance of knowledge from teachers to students became affected because of lack of preparation. This greatly affected the quality of education in the pharmacy colleges, especially in non-government colleges. Students are not being mentored up to the requirements which lead to a situation where the students are not competent enough to get good industrial jobs.

This is a very dangerous situation because if the student does not put sufficient effort from his side, he knows the reason behind the success in his professional career is the product of his efforts. But if the mentoring itself does not meet expectations, it leads to a huge amount of stress because they are under a false impression that they did their best in the training stage but when they come to the professional world reality hits like a train and their ambitions are crushed. Most students assume that they will never be competent enough and resort to switch their profession or chose to work at the most basic jobs available.

Peer Pressure

The most common source of stress among the pharmacy students was academic-related stress. The students also frequently reported personal life issues such as inadequate time for rest and recreational activities, lack of time for family and friends, interpersonal conflicts and environmental events as their sources of stress. This is not surprising as pharmacy training is a rigorous and strenuous endeavor which takes place in a competitive vocational environment.

After a student graduates from high school and moves away from home, he or she is often out of their comfort zone. Stress develops during this transition as the student tries to adjust to the new situations and adapt to a new college environment. Learning to cope properly with distress and eustress is important, as the behaviors established in college can continue for years or even a lifetime. If behaviors and habits resulting from stress management are maladaptive, they may have both psychologically and physiologically detrimental effects on the body and mind.

According to a study conducted by Sue Hui Sun to assess the stress among the undergraduate students of pharmacy, it was reported that the stress levels among the students varied with time. At the time of during the period where students needed to complete assignments, laboratory reports and also facing end of semester exams, stress levels were expected to be higher compared to that which was at the beginning of a semester. This suggests those students’ stress levels were not constant throughout the year but that students experienced higher stress at the time where assignments and examinations are near.

Vivek B. Waghachavare conducted a study of Stress among Students of Professional Colleges from an Urban area in India and found that gender was found to be one of the most important factors in the development of stress, with the results indicating a female predominance. The amount of stress in the students of pharmacy and medical profession was significantly high as compared to those of engineering students. This can be attributed to the fact that in India there has been a huge change of scenario in the past decade. In the earlier days, sending female children for education were not as widely encouraged as of today. This taboo still exists in certain communities of India which creates a mental stress on the female students because they are more likely to be a victim of criticism on failing to meet the expectations in terms of results.

Lack of Vision – The Career Killer

The major error that a pharmacy student makes in today’s world is that he lacks vision and that is where his professional life starts tumbling down the stairway. Most graduates begin their career in Pharmaceutical Industry with an idea of joining the company or post which gives them the best salary negotiation. Those who join a job role only for the money involved are not actually either qualified for the job or not interested in the role and thus they undergo huge amount of stress – as a result they burn-out more quickly than expected. This creates too much stress in the individual and also leads to the creation of a false notion in his mind about the Pharmacy Profession.

Let’s face it, the majority of pharmacy workplaces have developed a system of metrics in which a pharmacist’s performance is measured. Depending on the company, these metrics are created to determine the company’s success. Even if you as an individual disagree with these metrics, these are what the company values, and it’s up to you to identify and create a plan on how to execute without causing distress to yourself and sacrifice your passion or happiness. This plan will require you to audit yourself and your abilities and determine what will be needed in order to get the job done.

Although there are various other ways to becoming indispensable, by focusing on this key aspect, one can   grow their career beyond ways that they could imagine. It is going to be crucial for pharmacists to develop these skills moving forward. Their job security will depend on it.

Conclusion:

An optimal level of stress enhances learning, while excess of stress can cause health problems. This results in reduction of students’ self-esteem and affects their academic achievement. A high level of stress may have negative effect on cognitive functioning and learning of pharmacy students. The young student population is vulnerable to stress of higher professional education due to competitive environment.

Stressors can impact students either in a positive or negative manner. Majority of students display the effects of stress, as evidenced by their decreased academic performance and extra-curricular activities. The most predominant stressors were theory and practical examinations (both mid-sem and final), viva-voce and familial issues, among the others. While having a national and international leadership role we must also build on our local engagement. PCI and AICTE should also take some concrete decisions on ensuring that the students are gaining sufficient training in the educational institutes so that they become industry ready. With a basic knowledge of coping strategies, pharmacists can overcome stress to achieve their personal best.

One of the best ways to move forward would be to seek mentorship from experts or join an internship program which provides hands-on training in the actual industrial setup. This will help the students make better decisions for their future. There are few organizations in India that provide such training programs and internships. One such organization is Pharma Knowledge Centre® in Ahmedabad that focusses on bridging the gap between industry and the students by providing hands-on training, interactive sessions and internship programs – that makes the student confident for industry jobs which leads to a more sustainable workforce. This happens because such initiatives develop competence in the student, hence they perform better in their job roles.

References:

1. Votta RJ, Benau EM. Predictors of stress in doctor of pharmacy students : Results from a nationwide survey. Curr Pharm Teach Learn [Internet]. 2013;5(5):365–72. Available from: http://dx.doi.org/10.1016/j.cptl.2013.06.014
2. Sam AT, Muttusamy B, Yee SM, Ayapanaido T, Parasuraman S. Investigation of Stressors Affecting a sample of Pharmacy Students and the Coping Strategies Employed using Modified Academic Stressors Scale and Brief Cope Scale : a Prospective Study. 2016;8(2):122–7.
3. Awadh AI, Aziz NA, Yaseen SN, Abdulameer SA, Sahib MN, B OQ. A comparison study of perceived stress and quality of life among Master of Pharmacy and non- pharmacy master ’ s students. 2013;13(1):22–8.
4. Basak SC, Sathyanarayana D. Pharmacy Education in India. 2010;74(4).
5. Hirsch JD, Do H, Hollenbach KA, Manoguerra AS, Adler DS. Students ’ Health-Related Quality of Life Across the Preclinical Pharmacy Curriculum. 2009;73(8):1–6.
6. Review AS, Pharmacy ON, In E. of Biomedical AND Pharmaceutical sciences A STRATEGIC REVIEW ON PHARMACY EDUCATION IN INDIA WITH FUTURE. 2016;3(10):180–2.
7. Beall JW, Dehart RM, Riggs RM, Hensley J. Doctor of Pharmacy Students. 2015;344–54.
8. Behere SP, Yadav R, Behere PB. Original Article A Comparative Study of Stress Among Students of Medicine , Engineering , and Nursing. 2011;33(2).
9. Gallagher CT, Mehta AN V, Selvan R, Mirza IB, Radia P, Bharadia NS, et al. Perceived stress levels among undergraduate pharmacy students in the UK. Curr Pharm Teach Learn [Internet]. 2014;6(3):437–41. Available from: http://dx.doi.org/10.1016/j.cptl.2014.02.004
10. Sun SH, Zoriah A. Assessing Stress among Undergraduate Pharmacy Students in University of Malaya. 2015;49(2):99–105.
11. Jishnu V, Rm G, Dn M. Pharmacy Education in India : Strategies for a Better Future. 1932;3(4):334–42.
12. Assaf AM. Stress-induced immune-related diseases and health outcomes of pharmacy students : A pilot study. Saudi Pharm J [Internet]. 2013;21(1):35–44. Available from: http://dx.doi.org/10.1016/j.jsps.2012.02.006
13. Deepak K, Gaur A. Current scenario of pharm.d program of india. 2018;(March).
14. Waghachavare VB, Dhumale GB, Kadam YR, Gore AD. دنلها في ةيرضح ةقطنم نم ةينهلما تايلكلا بلاط ينب رتوتلا نع ةسارد. 2013;13(August):429–36.
15. https://www.pharmacytimes.com/publications/issue/2010/october2010/beatingjobstress-1010
16. https://timesofindia.indiatimes.com/city/hyderabad/with-job-scarcity-varsities-to-scrap-pharm-d-course/articleshow/65484088.cms
17. https://www.pharmatutor.org/articles/appearing-in-bpharmacy-examination-sessional-semester-end-year-end-final-examination-an-art-or-science%3F
18. https://www.pharmacytimes.com/contributor/alex-barker-pharmd/2015/06/common-pharmacy-technician-problems
19. https://medium.com/rxradio/saturated-pharmacy-market-are-you-in-trouble-a977792fbbbb
20. https://blog.herzing.ca/what-its-like-to-work-as-a-pharmacy-assistant-challenges-rewards-opportunities
21. https://www.researchgate.net/post/Present_Status_of_Pharmacy_Profession_in_India1
22. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5335855/
23. https://www.pharmacytimes.com/publications/issue/2010/october2010/beatingjobstress-1010
24. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2879119/

Pharma Knowledge Centre – “My Learning Life” (PKC) engaged Young Indian Youths to prepare this presentation/Blog and the same has been prepared by one of the associated youngsters in consultation with PKC.

All rights reserved. All copyright in this presentation and related works is solely and exclusively owned by PKC. The same may not be reproduced, wholly or in part in any material form (including photocopying or storing it in any medium by electronic means and whether or not transiently or incidentally to some other use of this presentation), modified or in any manner communicated to any third party except with the written approval of PKC.

This presentation is for information purposes only. While due care has been taken during the compilation of this presentation to ensure that the information is accurate to the best of associate and PKC’s knowledge and belief, the content is not to be construed in any manner whatsoever as a substitute for professional advice.

Associate and PKC neither recommend nor endorse any specific products or services that may have been mentioned in this presentation and nor do they assume any liability or responsibility for the outcome of decisions taken as a result of any reliance placed on this presentation.

Neither any associate nor PKC shall be liable for any direct or indirect damages that may arise due to any act or omission on the part of the user due to any reliance placed or guidance is taken from any portion of this presentation.

The post Pharmacy Life: The frustrations and issues that go along with working in Pharmacy appeared first on Pharma Knowledge Centre.

The main reason for being hauled up by a regulatory authority is the high level of risk assessment for each identified hazard. In the case of USFDA when it issues a 483s response format of inspectional observation, it is not adequately addressed by Indian companies. This leaves no option with the USFDA but to issue a warning letter. Companies do not indicate the problem instead they resort to quick fixes. Now the warning letter is perhaps a final alarm notice issued to a company before taking further legal action which includes an injunction, seizure and criminal investigation and thus drives the company out of business. The recent spurt in inspections and warning letters are adding to the woes of Indian pharma companies. Much of these issues arise because of the difficulty associated with the manufacturing process that includes not just oral formulations, sterile injectable and biologics.

There are a few characteristics that make Indian pharmaceuticals market unique:

1. Branded generics dominate, making up for 70 to 80 per cent of the retail market.
2. Local players have enjoyed a dominant position driven by formulation development capabilities and early investments.
3. Price levels are low, driven by intense competition. While India ranks tenth globally in terms of value, it is ranked third in volumes. These characteristics present their own opportunities and challenges.

India showed the largest gains in terms of perceived ‘quality of API’ and ‘finished product’ manufacturing, proving that industry efforts to align standards more closely with the USA and Europe have clearly been noted. But perhaps most significantly, these efforts are also being transferred into reported growth potential for 2019, with India forecast to grow faster than all other major pharma economies, scoring an average of 7.16 — placing it ahead of the USA (7.04) and China (6.81). Survey respondents cited India’s ‘high-growth domestic market’ and ‘expanding manufacturing exports’ as the major drivers. The rise in exports growth potential is believed to be in response to concerted reforms by the CDSCO (Central Drugs Standard Control Organization) and industry quality improvements in the last few years.

Export trends in Indian Pharmaceuticals:

India is the world’s largest provider of generic medicines; the country’s generic drugs account for 20 per cent of global generic drug exports (in terms of volumes). Indian drugs are exported to more than 200 countries in the world, with the US as the key market. Indian pharma companies are capitalizing on export opportunities in regulated and semi-regulated markets.

Pharmaceutical exports from India reached US$ 17.27 billion in FY18. The biggest export destination for Indian pharma product is the US. In 2017, 38 per cent of India’s formulated product exports were to the US, followed by 20 per cent to sub-Saharan Africa. In FY18, 31 per cent of total pharma exports from India went to the US. Drug formulations & Biologicals is the third largest among the principal commodities exported by India during 2017-18.

Fig: India’s Exports in 2017-18

The US is the top destination for Indian pharma exports, followed by the UK. America accounts for about 25 per cent of the country’s shipments. The other important destinations include South Africa, Russia, Nigeria, Brazil and Germany. Generic drugs form the largest segment of the Indian pharmaceutical sector, with 75 per cent market share (in terms of revenues).

India supplies 20 percent of global generic medicines in terms of volume, making the country the largest provider of generic medicines globally.

Such was the confidence in India’s pharma market, the nation was ranked joint second for ‘overall competitiveness’ of its pharma industry. India scored an average of 6.53, placing it behind only the US (6.98) and level with Germany (6.53). In addition to this, India saw the largest percentage shift in the score for quality of finished formulations, improving by 14.72 % since 2017.

Most impressively, should the same change be seen in 2019, the country’s reputation for finished product manufacturing will likely see it achieve parity with many European nations (whose scores have remained the same year-on-year) — a dramatic improvement on just a few years ago.

US-FDA Approvals by India throughout 2017-18

The USFDA approved 813 new ANDAs in 2018, the Year 2018 saw the second highest number of ANDAs granted final approval in a year, behind only the 846 approved in 2017.

Indian Pharmaceutical companies and their subsidiaries have established a strong presence in the US during the last couple of years with higher ANDA approvals. The loss of patent exclusivity and cost-cutting measures adopted by several nations pushed the demand for the generic segment. Indian pharma companies enhanced their investments in research and development (R&D) and successfully received higher approvals from the US FDA during the last decade. Out of total 5,350 ANDA approvals between 2009 to 2018, Indian companies have secured 34.4% of these approvals and received total 1,842 ANDA final approvals. Further, out of total 1,310 tentative approvals, Indian companies grab 500 tentative approvals from USFDA which worked out to over 38.2%.

During 2018, Indian pharma companies received 290 ANDA approvals from US FDA. The USFDA approved total final 813 ANDAs in 2018, slightly lower than previous year figure of 846. Thus, Indian pharma companies captured 35.7% of total approvals in 2018. Similarly, USFDA approved total 194 tentative products during 2018 as against 174 products in the last year and Indian company’s secured 77 tentative approvals in 2018 as compared to 61 in the 2017. The overall performance was under pressure due to USFDA actions against several Indian pharma companies regarding quality and issued warning letters. However, these companies started receiving approvals after successfully resolving warning letter problem.

Cadila Healthcare and its US-based division Zydus Pharmaceuticals (USA) Inc. received the highest number of ANDA approvals among Indian companies during 2018. Zydus Group has received 48 final ANDA approvals followed by Aurobindo Pharma 44 and Cipla 24. Lupin got 19 ANDA approvals and Dr Reddy’s Laboratories, Glenmark Pharmaceuticals and Strides Pharma received 17 approvals each in 2018. Sun Pharma and Taro Pharmaceutical received total of 20 ANDA approvals. Among the tentative approvals, Aurobindo Pharma remained on top with 10 approvals, followed by Zydus Pharma 9 and Lupin 7. Cipla and Ajanta pharma received 6 tentative approvals during 2018. Cadila Healthcare has incurred R&D expenditure of Rs.690 crore during 2017-18 and it received 77 approval for new products for the US market.

Aurobindo Pharma, a second largest pharma company in India with consolidated net sales of Rs.16,200 crore plus, has invested Rs.667 crore during the year ended March 2018. It launched 38 products in the US, including six injectables. Cipla Rs.14,750 crore pharma giant, has continued to invest in building a strong product pipeline through R&D, which contributed significant growth in US revenues. Its annual R&D investment crosses Rs.1,000 crore and reached at Rs.1,074 crore during 2018.

Besides, these top three companies, Dr Reddy’s Laboratories, Glenmark Pharma, Sun Pharma and Strides Pharma received final ANDA approvals over 15 products each during 2018 from USFDA. Hetero Laboratories and Micro Laboratories got approvals for 9 products and 8 products each during 2018. Further, Ajanta Pharma, Alembic Pharma, Gland Pharma, Macleods Pharma and Torrent Pharma received 7 ANDA each during 2018. Alkem Laboratories and Granules India received approval for 6 and 5 products each from USFDA.

483s and Warning Letters and Import Alerts:

The number of drugs GMP warning letters continues to increase over the previous years, from 42 in FY2015 to 102 in FY2016 and to 114 in FY2017 and 127 in FY2018.

The above data shows that drug GMP warning letters have been doubled from FY2015 to FY2016 and increased again in 2017 and 2018, though not be as large a percentage.

Country wise disteibution of Drug GMP Warning Letters Issued

The table above shows the geographic distribution of warning letters issued outside the U.S. China received the largest number of warning letters issued to a single country in FY2018 and over the six-year period. India received the next highest number of warning letters, followed at a distance by Europe. Over the past four years, the number of warning letters to sites in China has steadily increased, while warning letters issued to sites in India have increased, then held steady.

Focus on OTC Manufacturers

Financial Year (FY) 2018 included a dramatic focus on OTC manufacturers worldwide reminiscent of the focus on compounding pharmacies and outsourcing facilities that began in 2014. Below table shows the warning letter enforcement data on this group of manufacturers for the last 11 years. The dramatic changes began in FY 2017 and increased again in FY 2018. The numbers for FY 2018 will likely increase beyond those reported here as additional warning letters issued in 2018 are posted in early 2019.

Highlighting the top deficiencies during audits by the international regulatory agencies including USFDA are:

• Inadequate quality standards
• Lack of in-house investigation on batches that fail to meet specifications
• No written processes or insufficient standard operating procedures at pharma manufacturing plants.

Not just in India but several other countries have seen these serious shortfalls. Since 2008, the number of inspections has increased but in the last six months, there has been a significant rise in the number of checks by USFDA and EMA. But the USFDA has now raised the safety concerns of many pharma manufacturers in India because it has been noted that Indian manufacturers do not give a view that their facility is on a continuous improvement process.

Further, there are clear indications of no process controls that validate the performance of manufacturing process, with nil maintenance checks on equipment cleaning, poor control of components, intermediates and raw materials besides quality assurance deficiencies. Another issue is that once the faults are pointed out by the regulator, companies submit unsatisfactory reports recording only one side of the situation with no details of the full statement that confuses the global investigators. In 2012, under the 10 drug inspection deficiencies indicated, 118 were due to poor adherence to quality processes, 78 of them were a failure to thoroughly review and 75 complaints were attributed to the absence of written procedures.

All these issues have forced the USFDA to issue warning letters because it has perceived violations to be of serious significance. The FDA does not trust the company to correct the problems sufficiently on its own and sees a lack of seriousness. Failure to establish corrective and preventive action (CAPA) following an investigation is the cause of non-conformities. Early preparation of a warning letter is likely to be based on 483s format which is a guide in the early preparedness to prevent severe lapses. The cost of an FDA enforcement action is more expensive than the cost of a robust compliance process.

 Data Integrity Deficiencies in Warning Letters

The above table shows the number of warning letters issued both inside and outside the U.S. that included references to data management and data integrity. This analysis exclude those warning letters issued to compounding pharmacies. Warning letters referencing data integrity deficiencies continue to identify the predicate rule(s) to which firms did not adhere. The percentages for both U.S. and OUS warning letters have consistently decreased between FY2016 and FY2018; perhaps we’ve turned the corner here, but we still have a long way to go to eliminate this problem.

Pharmaceuticals utilize an increasingly global manufacturing supply chain. Common approaches to organizational behavior may not always be effective due to societal considerations and there are many different influences on quality culture. We should be prepared to accept that an effective quality culture in one region may look different from that in another. By being sensitive to the influence of global culture on organizational behavior, we gain insight into the effectiveness of the ‘vigilance’ part of the quality culture, which can influence the selection of metrics. What matters is that the desired outcomes are achieved.

A strong quality culture is built upon:

• Knowledge and skills of what is important, and how a process achieves critical quality attributes
• Diligence, by fostering awareness that everyone contributes to product quality, and understanding that “my actions impact the patient and the company”
• Vigilance by individuals who know what ‘right’ and ‘wrong’ look like in their process, and a mechanism for management to be aware of problems
• Senior management commitment to being visible and transparent in decision-making so that positive outcomes can be seen from the diligence and vigilance efforts. This is more than the company mission statement – it’s ‘walking the talk’.

Impact of WTO:

The Pharmaceutical regulatory environment in India comprises of the Central Government (DCGI) and the State Government (DCO). The Drugs and Cosmetics Act, 1940 (Drugs Act) and Drugs and Cosmetic Rules, 1945 (Drug rules) regulate the import, manufacture, distribution and sale of drugs in India. Under the provisions of these Acts, the Centre appoints the Drugs Technical Advisory Board (DTAB) to advise the Central Government and the State Governments on technical matters.

In January 2005, India complied with the World Trade Organization (WTO) to follow the product patent regime known as the Trade-Related Aspects of Intellectual Property Rights (TRIPS). Before the TRIPS Agreement, most of the developed countries granted patents on drugs, but many developing countries including India only granted patents for the process of producing an invention (For example, the method of producing a drug) but not for the product (the drug itself).

As a result, generic copies of original drugs (generic drugs) were made or imported into these countries without getting permission from the patent holder. Hence, the prices of medicines were often lower because of generic competition against patented drugs. The TRIPS Agreement attempted to end this practice by implementing the International Patent Law.

From the Industrial point of view, TRIPS will give the patent holders the right to restrict their competition and therefore sell a certain drug in a monopolistic environment.

However, prices of medicines would continue to rise, making access more difficult and adversely affecting the local pharmaceutical industry. Production of generic equivalents to expensive branded drugs will be limited because of 20-year patent protection for pharmaceutical products and processes.

The new Pharmaceutical Policy, notified in 2012, intends to bring 348 essential drugs in the National List of Essential Medicines (NLEM), under the purview of the DPCO. With this policy, the market size of drugs under price control will increase from 15-20% of the domestic formulations market to 20-30%.

The government has launched two schemes—New Millennium Indian Technology Leadership Initiative in 2003 and the Drugs and Pharmaceuticals Research Programme in 1994-95—which are specially targeted at Pharmaceutical Research.

Top 10 US FDA Certified Manufacturing Plants in India with their Market Capitalization:

According to a recent study, here is a chart showing the Top 10 USFDA certified manufacturing sites in India with their Market Capitalization.

Future Opportunities and Challenges:

The Department of Pharmaceuticals has drafted ‘Pharma Vision 2020’ document, with an aim to establish India as a leading county for end-to-end drug manufacturing and innovation.

This initiative by the government aims at providing support to the Indian pharmaceutical sector through state-of-the-art infrastructure, internationally competitive scientific research personnel for pharmaceutical R&D and funding for research in the public and private sectors.

The Central government is preparing for a multi-billion-dollar investment in the pharma sector with 50% public funding through its public-private partnership (PPP) model to enhance innovation capability.

According to the ASSOCHAM, the idea is to push India into the top five pharmaceutical innovation hubs by 2020 and establish a global presence by launching one out of every 5-10 drugs discovered in India at a global level.

In a pessimistic scenario characterized by regulatory controls and economic slowdown, the market will be depressed and is expected to reach USD 35 billion.

In the base case scenario, all the important growth drivers will witness robust progress. The market will grow more than four times to reach USD 55 billion by 2020.

On the other hand, an aggressive case scenario, spurred by external conditions and purposeful industry actions, is definitely possible. In this scenario, GDP is expected to grow at around 8.3 per cent.

These advancements will surely put India in good competition with the regulated markets and will in turn greatly increase the export revenue.

India has made phenomenal progress in both DMF, ANDA and Biosimilar approvals over the past 7 years.

The country’s share in ANDA approvals and tentative approvals during the past years early demonstrates its aggressive ambition towards the US market. There are over 1000 molecules that provide a great opportunity for India to expand its presence in the US pharmaceutical market. India is weak in various segments such as corticosteroids, respiratory, musculoskeletal, and ophthalmic and so on and has to develop its capabilities in bio-generics for its future growth.

The pharmaceutical products from India are mostly confined to conventional tablets and capsules with very little presence in advanced formulations and completely absent from non-conventional dosage forms. India has to, therefore, urgently take corrective action to move into a higher orbit of complex chemistry, Biotech-based medicines and advanced formulations.

Overall, the exact quantum of the hit that Indian players had to deal with in the US market, varies from company to company but analysts point to many companies reporting 20 to 30 per cent decline in their US business and a price erosion to the tune of 15 to 20 per cent.

In this trend and in the overall scene there are perhaps hopes for a better 2019. Those within the industry apart from some of the leading analysts feel that things will start improving in 2019. This is linked to an expectation that many of the issues faced by Indian companies in their major export market US, will stabilize. The same also holds true for the Indian market, since in the year 2018 many companies were finally able to put behind the setbacks they had encountered on account of the Goods and Services Tax (GST) and demonetization.

Hurt by de-growth at one-point post-GST and later a single-digit growth, the domestic market growth is expected to stabilize at between 10 to 12 per cent. However, Indian pharma is also coping with cost increases in active pharmaceutical ingredients (APIs) from China, which is tightening its regulatory norms. The year also saw some significant acquisitions. For instance, IHH won the bidding war for Fortis Healthcare and Hyderabad-based Aurobindo Pharma acquired the dermatology and oral solids businesses from Sandoz Inc., USA.

As we enter the next millennium, we have to set up a vision for the New India of our dreams. This vision cannot merely be a derivative of the past. It has to be, of course, based on the reality of the present, but it has to have boldness, ambition and hope which is commensurate with the aspirations of our great nation.

We already see the winds of change. The world is going digital and also herbal. There are great opportunities for India in both areas due to its vast reservoir of intellectual capital, its rich bio-resource and its rich heritage of knowledge of the traditional medicinal system. Whereas we are already tapping into the multibillion-dollar “Digital” market, we have an opportunity to be a significant player in a multibillion-dollar “Herbal” product market too. Opportunities for becoming a global player in this market exist, but it will require an astute combination of new and traditional knowledge, innovation and creativity, and that too in the entire journey of mind to the market place.

References:

1. United States Food and Drug Administration (https://www.fda.gov)
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Pharma Knowledge Centre – “My Learning Life” (PKC) engaged Young Indian Youths to prepare this presentation/Blog and the same has been prepared by one of the associated youngsters in consultation with PKC.

All rights reserved. All copyright in this presentation and related works is solely and exclusively owned by PKC. The same may not be reproduced, wholly or in part in any material form (including photocopying or storing it in any medium by electronic means and whether or not transiently or incidentally to some other use of this presentation), modified or in any manner communicated to any third party except with the written approval of PKC.

This presentation is for information purposes only. While due care has been taken during the compilation of this presentation to ensure that the information is accurate to the best of associate and PKC’s knowledge and belief, the content is not to be construed in any manner whatsoever as a substitute for professional advice.

Associate and PKC neither recommend nor endorse any specific products or services that may have been mentioned in this presentation and nor do they assume any liability or responsibility for the outcome of decisions taken as a result of any reliance placed on this presentation.

Neither any associate nor PKC shall be liable for any direct or indirect damages that may arise due to any act or omission on the part of the user due to any reliance placed or guidance is taken from any portion of this presentation.

The post INDIA’S GLOBAL LEADERSHIP IN US-FDA APPROVALS: 2018 – 19 UPDATE appeared first on Pharma Knowledge Centre.