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to any generic version of any drug already having valid patents in India, although the statement had subsequently been retracted.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.