Azad for revisiting FDI norms in pharma sector

Expressing serious concern over the takeover of Indian pharma firms by multi-national companies, Union Health Minister Ghulam Nabi Azad has sought revisiting of FDI norms in the pharmaceutical sector.

In a letter to Commerce Minister Anand Sharma, Azad said, "the issue of takeover of Indian pharma companies by MNCs, which is of serious concern, needs to be tackled effectively only in terms of FDI Policy for the pharmaceutical sector".

The minister argued that the takeover of the Indian companies by the MNCs was having an effect on the availability and affordability of medicines particularly life saving drugs in India and other developing countries.

"FDI in this sector needs to be revisited immediately and such investments should be shifted from the automatic route to the Foreign Investment Promotion Board (FIPB) route, if we have to ensure healthy growth of pharmaceutical industry and availability and access of our people to quality and affordable medicines, which is so critical from the requirement of public health," the letter said.

He said that the Indian Drugs and Cosmetics Act does not recognise data exclusively and patent linkage. Thus, the Drug Controller General of India is competent to issue market authorisation of generic version of patented drugs after following the procedure prescribed in terms of bio-availability, bio-equivalence, clinical trials etc.

Accordingly, Drugs Controller has given approval to Indian generic manufacturers for certain drugs in respect of which patent is still valid.

"If, however, any particular company succeeds in securing the infringement suit decided in its favour, the provision of compulsory licensing (under Patents' Act) could be necessary if the patented drug is required to be made available at a reasonable price to the public," Azad said, adding his Ministry was ready to work together to promote the cause of public health in the country.

Meanwhile, the Indian Drug Manufacturers' Association has written a separate letter to Prime Minister Manmohan Singh, expressing concern over the takeover of Indian pharma companies by MNCs through tie-ups.

Six major acquisitions of Indian companies have taken place in the last four years-- Ranbaxy, Dabur pharma, Shanta Biotech, Piral health care, Matrix labs and Orchid chemicals, the letter said.