send mail to support@abhimanu.com mentioning your email id and mobileno registered with us! if details not recieved
Resend Opt after 60 Sec.
By Loging in you agree to Terms of Services and Privacy Policy
Please specify
Please verify your mobile number
Login not allowed, Please logout from existing browser
Please update your name
Subscribe to Notifications
Stay updated with the latest Current affairs and other important updates regarding video Lectures, Test Schedules, live sessions etc..
Your Free user account at abhipedia has been created.
Remember, success is a journey, not a destination. Stay motivated and keep moving forward!
Refer & Earn
Enquire Now
My Abhipedia Earning
Kindly Login to view your earning
Support
“Health & Nutrition” has been a critical issue in India since its independence. The critical problem malnutrition in India gets only aggravated i the wake of Rampant Poverty. The priced privilege of Indian Demographic dividend will cease to be a resource in the wake of this problem. Acknowledging this issue, the Government of India has taken several steps to make available nutrition and medicines (generic) at affordable prices (Ex: Jan Aushadhi Scheme, etc). However, the recent proposal to extend the time limit for State-level drug regulatory approvals from four to 10 years could effectively result in a long and damaging data exclusivity and hit the generic market.
Data exclusivity is a kind of intellectual property protection wherein clinical trial and other data submitted by an originator drug company cannot be used or relied upon by a drug regulatory authority to approve a generic version of that drug for a certain period of time. The notion is that without such protection, the originator company lacks the necessary commercial incentive to conduct expensive trials and take a potential drug to the market. Blocking generic entry for some years will, the theory goes, help drug companies invest in clinical trials. To simplify it, top multi-national pharmaceutical giants spend time, money and huge investment (Research and Development) to assess the efficacy, quality and safety of the new product. This process is known as clinical trial and it involves enormous amount of expenditure, time and money. For example clinical trial process to test the efficacy, quality and safety of a new anti-cancer drug may take 6-7 years or in some cases even 15 years. Then the regulatory authorities in different countries will analyze those data in order to ensure that only medicines having safety, efficacy and quality enter into the market. Often the national regulatory authorities would ask the innovator or originator drug companies to provide relevant information and data to assess the safety, efficacy and quality of the drugs. Such data are very crucial and it contains all details of clinical trials and it is this data that originator companies seeks to protect so that generic companies cannot use such data because such data are result of long term effort and investment put into clinical trials and hence it will be extremely unfair to allow a third party (generic drug makers) to make a commercial exploitation of such data. In order to protect such data originator companies are demanding data exclusivity law so that such data submitted to regulatory authorities are not exploited by generic drug makers to test the quality, efficacy and safety of bioequivalent generic version of that medicine. The originator companies which are giant multi-national pharmaceutical companies want such data to be protected for a certain period of time so that during that period, generic companies are precluded from using such data to test the quality, efficacy and safety of the generic version of that medicine. Data exclusivity is a matter of heated controversy now-a-days all over the world and a source of tussle between developing and developed countries on the one hand and Multinational drug companies and Domestic pharmaceutical companies on the other. Data exclusivity is a kind of intellectual property protection wherein clinical trial and other data submitted by an originator drug company cannot be used or relied upon by a drug regulatory authority to approve a generic version of that drug for a certain period of time.
Countries like US and UK have been pressurising India since long for data exclusivity norms.India has a huge generic medicine market, so India sees it as a barrier to generic entry and affordable drugs prices.
a.) Domestic Law concerning Data Exclusivity: For India, agreeing to data exclusivity will mean amending the Drugs & Cosmetic Act (FDA law) so that the Indian Drug Regulatory Authority (DRA) is prohibited from registering a more affordable version of a medicine as long as the exclusivity lasts over the clinical trial data • Under the Act as it stands now, a new drug continues to remain “new” even after it has been approved once by the Central regulator (Drugs Controller General of India, or DGCI) upon submission of local clinical trial data establishing safety and efficacy in India. • However, it loses “newness” after four years, which means a drug manufacturer can short-circuit the process and go directly to a State regulatory authority and procure drug approval. • It is this four-year period that is now sought to be enhanced to 10 years, an extension that the IPA argues constitutes an enhancement of data exclusivity norms in favour of large pharma companies, particularly MNCs. Others insist that there is no such data exclusivity norm in India.
b.) International Law on Data Exclusivity The Pharmaceutical companies are demanding data exclusivity law by resorting to Article 39(3) of TRIPS. Article 39(3) of the TRIPS states that that “Members when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilise new chemical entities, the submission of undisclosed test or data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use. In addition, Members shall protect such data against disclosure, except where necessary to protect the public, or unless steps are taken to ensure that data are protected against unfair commercial use."
However it should be remembered that Article 39(3) does not talk about “Data Exclusivity” but only about “unfair commercial use” and it is this phrase that is interpreted by Multi-national companies as containing “Data Exclusivity” provision and thus demanding data exclusivity law.
Indian Government’s Stand? • The Government of India has made clear that Article 39(3) does not bind her to implement data exclusivity law and it is under no obligation to enact the law on data exclusivity. The Government of India is of the opinion that Article 39(3) only requires WTO members to protect the test data against any “unfair commercial use” It neither includes market exclusivity to the innovator nor does it create market protection. • If the government wants to enact such law, it can do either by amending Indian Patent Act, 1970 or Drug Control Act, 1940 or by amending Drugs and Cosmetics Act,_ and inserting a new section on data exclusivity.
Opinion of the Intellectuals and Experts: • Who is right or wrong? in large depends on the kind of data that generic companies have to submit in order to gain approval for their follow-on drugs. If they are forced to submit the same kind of clinical trial data that originators have submitted to the regulatory authority, then this does amount to data exclusivity. For almost all generics will simply wait for the term (four years) to expire rather than undertake the expensive process of generating clinical trial data afresh. • Extension will delay competition and hurt patients. It will seriously compromise not only growth of the national pharmaceutical industry but deny access to affordable medicines as well. • The data exclusivity is a TRIPs plus measure. Several eminent scholars, researchers and institutions have advised nations against providing data exclusivity as it would compromise access and affordability. The Parliamentary Standing Committee on commerce had also outright rejected the data exclusivity. • On the other hand, The Organisation of Pharmaceutical Producers in India, representing multinational drug makers has welcomed the proposed amendment. • Global drug makers stand strongly in favour of data exclusivity laws?
One may argue as to why have this four-year or 10-year time lag at all for generic drug approval? Shouldn’t generic drugs be approved on Day One, so long as they are able to demonstrate that they are as robust as the new drug that has already been approved once? But an undeniable fact remains that expensive trials need to be incentivised and pursued consistently which ultimately would result in the consistent improvements in the efficiency of the drugs. Since the matter is very controversial and each side has their own valid points, it must be remembered that the issue relates to the accessibility and affordability of the life saving drugs to millions of people in third world countries and any rigid or adamant attitude from any side will adversely affect all especially the common people. Each side should try to find a middle-path formula so that interest of all can be reconciled with the larger interest of the common people in developing and third world nations. Measures like: “govt funding for clinical trials and R&D”; “focussing more on prevention than the cure”, etc can be viable solutions.
*Readers are requested to suggest more solutions to this issue in the comments*
By: Chandan Sharma ProfileResourcesReport error
Access to prime resources