Marketing approvals for generic drugs may soon get delinked from their patent status, a long-standing demand of India’s pharmaceutical industry that depends heavily on the sale of generic drugs.
The health ministry is planning to remove a question on the patent status of a drug from the form that medicine companies fill in when applying to the Drug Controller General of India (DCGI) for regulatory approval, a ministry official said.
The proposal follows a meeting in Mumbai this month between Indian drug makers and health minister Ghulam Nabi Azad.
“Removal of the question of patent status was agreed to, in principle, at the meeting. But now, it has to go to the drug technical advisory board (DTAB, the highest advisory board for drugs) for approval,” the official said, requesting anonymity.
If deleted, the DCGI will issue approvals only on the grounds of drug quality and efficacy.
The decision may influence a patent linkage case over an anti-cancer drug pending before the Supreme Court.
US drugmaker Bayer Corp. and its Indian unit Bayer Polychem (India) Ltdhave sought to restrain DCGI from granting Indian company Cipla Ltd approval to market a generic version of its anti-cancer drug.
DCGI opposed Bayer on the grounds that being a drugs quality control body it does not have the expertise to interpret patents.
Bayer’s appeal was dismissed in the high court in February, after which it petitioned the apex court.
The Indian pharma industry welcomed the ministry’s proposal.
“The minister saw some sense in our recommendation and agreed to it. Why should the drug regulator have any linkage with the patent status of a drug?” said Daraa B. Patel, secretary general of the Indian Drug Manufacturers’ Association.
“This is good news,” said D.G. Shah, secretary general of the Indian Pharmaceutical Alliance.
“This is what was required through a very clear decision from the high court and the government’s own policy. There is no provision of patent linkage in the Drugs and Cosmetics Act. So the way patent linkage came about was itself without any basis.”
In 2008, the DCGI publicly said he won’t grant marketing approval to generic versions of drugs that already have valid patents in India, but later retracted. The health ministry will now wait for the next DTAB meeting.
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