Health Ministry’s new bid for cancer drug copy nixed

In what should come as relief for US drug major Bristol-Myers Squibb, the Ministry of Commerce has rejected a fresh proposal by the Health Ministry seeking a compulsory licence for production of a copy of its patented blood cancer drug, Dasatinib.

In its response, the Department of Industrial Policy and Promotion (DIPP), which is a part of the Commerce Ministry and responsible for such approvals, said the Health Ministry’s arguments did not conclusively prove that a generic version of the medicine was needed.

“We have written back saying that we could not support their proposal as more justification was required,” a DIPP official told BusinessLine .

The Health Ministry had proposed that a compulsory licence be given for a generic version of Dasatinib in January this year and then again in May after the DIPP asked it to specify why it wanted the Centre to step in. In the second proposal, it said the licence should be granted for ‘public non-commercial use’ and the cost of producing the blood-cancer medicine be met through Government schemes.

Boost for developers The DIPP’s refusal will go down well with large pharmaceutical companies — most of which are based in the US and Europe — that have been complaining about India’s intellectual property regime being too lax.

Faced with pressure from its pharmaceutical lobby, the US Government, too, is investigating if there is a case to blacklist India as a country with inadequate patent protection.

TRIPS compliant A compulsory licence can be issued by the government under the Trade Related Intellectual Property Rights — the international pact on intellectual property. It is a permit for the production of copied versions of patented medicines without the consent of the patent holder, so as to address public health concerns.

However, the onus is on the Government that issues the licence to ensure judicious exercise of this right.

“We can’t be casual about issuing a compulsory licence. We have to justify it to the company that will be affected,” the official said.

The second way of getting a licence is by approaching the Indian Patent Office, where the applicant company has to prove that the patented medicine is beyond the reach of the public because of its price. It would also have to be able to supply it at a much lower price.

Only one licence So far, India has issued just one compulsory licence, to Hyderabad-based Natco, for the sale of a generic or copied version of Bayer’s anti-cancer drug Nexavar. It was the Indian Patent Office that granted the licence to Natco, which said it would cost ₹8,800 for a month’s treatment compared to Bayer’s ₹2.8 lakh.

Since the Indian Patent Office had rejected an application by BDR Pharma for a compulsory licence for Dasatinib last October, the Health Ministry decided to ask the Centre to issue the licence.

COMMENT NOW