Drug Regulation

Spicy IP Tidbit: Health Ministry set to resolve Patent Linkage Question for Drug Marketing Approval Once and for All


For the Indian pharmaceutical industry, it may seem that Christmas has arrived a little bit early this season. The industry has always relied heavily on the marketing of generic drugs since its inception. Its job was not made easier by the governmental requirement for the patent status of a generic drug to be disclosed before it could be granted marketing approval. When an application is made by a medical company to the Drug Controller General of India (DCGI) for such regulatory approval, the application form contains a question to such effect, which the Ministry of Health intends to remove, after a long period of lobbying by the pharmaceutical industry.

As reported by Radhieka Pandeya in Livemint, this was the outcome of a meeting that had taken place in September in Mumbai between the industry leaders and the health minister Mr. Ghulam Nabi Azad. However, according to an official source, the proposal needs to be approved by the Drug Technical Advisory Board before it can come to effect.

If it is indeed approved, then it would mean that DCGI would issue approvals to new drugs only depending on their quality and efficacy regardless of their patent status, something that is going to have wide repercussions in several pending cases, such as the patent linkage matter over an anti-cancer drug Nexavar between Bayer Polychem and Cipla, reported here, here, here and here. Readers may recall that Bayer had sought to prevent DCGI from issuing approval to Cipla for marketing a generic version of Bayer’s anti-cancer medicine. DCGI cited lack of patent-interpreting expertise in return, being in charge of drugs quality control only. The matter is currently pending before Supreme Court and is likely to exhibit considerable impact if the query about patent status of drugs is removed from DCGI’s form as proposed.

The reaction from the Indian pharmaceutical industry so far to this proposal has been one of considerable approval, as voiced by Daraa B. Patel, secretary general of the Indian Drug Manufacturers’ Association and D.G. Shah, secretary general of the Indian Pharmaceutical Alliance, who have welcomed this move as being only too logical given the lack of patent linkage provisions in the Drugs and Cosmetics Act. It may interest readers to know that back in 2008, the DCGI had declared not to grant approval to any generic version of any drug already having valid patents in India, although the statement had subsequently been retracted. At present, Health Ministry officials are awaiting the next meeting of the Drug Technical Advisory Board to bring up this proposal for approval. As usual, the Spicy IP Team stands ready to keep the readers updated about any further development.

Shouvik Kumar Guha

Shouvik is at present employed as a Research Associate and a Teaching Assistant at The W.B. National University of Juridical Sciences, Kolkata. He has obtained his B.A. LL.B. (Hons.) degree from NUJS itself and is also currently pursuing his LL.M. degree from the same university. From his very year at law school, he had been attracted towards the discipline of Intellectual Property and that interest has been kindled further in course of time. The interface between IP and other disciplines such as Economics, Anti-trust Law, Human Rights, World Trade Law and the technological developments relating thereto, has especially caught his attention since then. He’s authored several papers on issues relating to IP and other legal disciplines for journals, books, magazines and conferences in national as well as international levels. He is also currently co-heading an organization called Lexbiosis, which is an endeavor meant to facilitate the collaboration between the legal industry and academia.

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