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  • Writer's pictureSanjay Trivedi

No generic drug is allowed unless it qualifies all regulatory parameters

A Round Table Discussion on Prescribing Generic Vs Branded Drugs: Impact and Implications on Health Care

On the occasion of 56th National Pharmacy Week, DELHI PHARMACEUTICAL SCIENCES AND RESEARCH UNIVERSITY organized a round table discussion on the topic-Prescribing Generic Vs Branded Drugs: Impact and implication over Healthcare where experienced professional from different backgrounds from the industry participated and contributed their views over Branded and Generics medicines and their possible impact on healthcare industry considering all stakeholders i.e. Doctors, Patients, Pharmacist and Pharmaceutical companies.

Dr.Naresh Sharma, Asst Drug Controller (India), CDSCO, gave a brief about existing regulatory framework in the country with an overview about different centers of Generic medicines and illustrated about the clinical trial surveys are done by the Government of India to check effectiveness of Generic medicines. He emphasized the need of a revised regulatory mechanism to promote generics so as to make the medication more affordable and available for public. To express the dilemma of common people in India with respect to branded and generic medication, a street play was performed by the students of the university, beautifully defining how Indians are facing problem due to extra burden of medications (high price) for their family members and showcased the concept and benefits of Jan AushidhiYojna.

Dr Sharma narrated that no generic drug is allowed unless it qualifies all the regulatory parameters of Drug Control Authority of India. There is already a compendium of about 7000 approved generic drugs that is available in public domain. Regulatory authorities undertake regular inspection for quality checks by randomly picking up samples of generic drugs from the chemists’ shops. He mentioned that the drugs failing to meet the criteria is <0.5%.

The discussion began with the opening remarks of Prof R.K Goyal, Hon’ble Vice Chancellor and Dr. S Dwivedi, Chairman, BOG, DPSRU, where they shared their experience over confusion on prescription of Branded medication and generic salt dispensed by the Pharmacists. They gave examples of confusing nomenclature and certain basic rules prescribed for calling a particular medicine “generic”. They described howa blanket mandate to prescribe generic medicine can generate problems for physicians. One of the examples was prescription for a cough syrup.

Dr.Harvinder Popli, Principal and Dean, DPSRU laid emphasis over the real situation prevailing in India in terms of the laws and regulation passed by the Government for the Generics Drugs as well as quoted the real statistics comparing the branded and generic medication. Dr. Vinod Sharma, Vice CEO, National Heart Institute shared a clinician’s perspective on this subject matter. Being a clinician, he expressed his concerns about the issues of Quality, Safety and Efficacy of Generic medicines. In his views, compared to Branded drugs, generic drugs are less regulated in terms of quality control. He cited a couple of examples where the Brand names of 2 generic drugs were exactly the same for the APIs content. However, they did not match and were meant for different therapeutic areas. He was also of the view that a pharmacist may not be able to judge from options between generic and branded drugs to fill the prescriptions, the Clinicians specific prescription for the particular medicine is must.

Dr. Dinesh Sharma, General Manager, Jubilant Generics Ltd. illustrated Industrial perspective on Generics, and how different pharmaceutical companies are evolving generic version of innovator(Branded medicine) considering the economic feasibility for end customers (patients). He emphasised on the fact that there is a gap between the quality of generics we export and what we get through import.

Industry has facilitated access of affordable medicine for India and world. As perDr. Dinesh’s perspective, the Pharma Industry follows regulatory compliance to ensure high quality end products which is similar and meets all specifications of the Branded drugs before it is licensed to enter the market. He also mentioned about the upcoming concept of Digital Medicine in which the drugs can be made available in the form of edible chip.

Dr. Sanjay Sharma, Head (India), Nortons group, spoke about the necessity and affordability of generic drugs for lower income group patients as the primary objective for attaining “Health for all”. Mr. Bejon Misra, an international Consumer Policy Expert and a renowned social activist expressed his views about the importance of Jan Aushadhalya in today’s practice, shared his experiences and motivated students to become an active part of the system with an idea to serve the society and describing the importance of ethics in each and every profession.

Mr. Misra shared his experience of Jan Aushadhi Kendra at Varanasi which won the best center for second successive year. He believes that this drive should have coverage on pan India basis with opening of more such Jan Aushadhi Kendras providing affordable generic medicine that is within reach to every citizen of India. He suggested that it is important to establish the trust about the quality of generic drugs which can be achieved by first using these drugs for ourselves.

The students of Masters in Public Health program: Komal, Deepshikha, Falak, Dhiraj and Rameshwar had conducted a survey in some hospitals to analyse thePublic opinion and awareness on the Generics vs. Branded Drugs.They presented a conclusive report of their survey, followed by an Open House session with full of queries and answers which cleared the various issues like the feasibility of generic drugs, incentives involved, availability and sustainability in market.

Dr Shridhar Dwivedi, Chairperson of BOG, DPSRU summarized the discussion along with his own views as a practicing clinician. He expressed his concern about the medicine cost difference between India and other countries and accessibility of quality generics for ensuring Health for All. Following were the final take home messages:

  1. A fundamental component of access to medicines is affordability.

  2. Our government has taken several steps for Universal Health care by introducing many initiatives.

  3. Healthcare infrastructure have to get equipped with sincere physicians, pharmacists, administrators and other healthcare partners to intelligently handle the problems associated with the availability, quality and price of essential medicines.

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