The committee on compulsory licences, set up under the health ministry, is set to meet on Tuesday to reconsider invoking the provision for three key patented anti-cancer medicines - trastuzumab, ixabepilone and dasatinib - sold by multinational pharmaceutical companies.
The committee, headed by R Jain, additional secretary in the health ministry, had initially recommended compulsory licences for these three drugs to the department of industrial policy and promotion (DIPP), a wing of the commerce ministry which looks into intellectual property rights (IPR) issues and has the power to invoke Section 92 of the patent law to issue compulsory licences.
DIPP had sent back the earlier proposal in this regard to the health ministry, seeking additional details on 21 different issues such as prices, efficacy levels and size of the patient pool in need of such treatment.
"We have gathered all the information sought by DIPP but the panel wants to meet again to discuss the issue in detail," a senior official, who is part of the panel, told Business Standard. He added the committee would consider whether the government should consult multinationals involved in the matter before going forward.
Among the three drugs under scrutiny, trastuzumab is manufactured and patented by Roche. The other two - ixabepilone and dasatinib - are patented products of Bristol-Myers Squibb.
Multinationals have expressed concern that the government had not consulted or initiated any dialogue with them before taking this step. "The government should first look for alternative routes to make medicines available and affordable for patients. Issuance of compulsory licence is an extreme step and could have been avoided by engaging in a dialogue with innovator companies,"said an official of a foreign firm selling patented medicines in India.
The government is also being cautious because India is already facing criticism for recent decisions on IPR-related issues. India has so far issued only one compulsory licence. However, it was granted under a different section by the patent controller to Hyderabad-based Natco Pharma, which offered to sell a generic version of Bayer's anti-cancer medicine, Nexavar, at Rs 8,800 for a month's therapy as against the German firm's price of Rs 280,000 a month.
The recent verdict of the Supreme Court in denying patent protection to Swiss multinational Novartis for its drug, Glivec, was another factor. In the wake of these developments, the government wants to be fully prepared with facts and figures to be able to support its decision, if challenged in a court of law.