Govt steers off branded generics

The coming pharmaceutical policy is likely to catalyse debranding of generics by laying down that no branded drug will be considered for the government's bulk procurement programme.

Also, unbranded drugs will be kept out of the price control mechanism. Branded generics, on the other hand, will be treated as branded drugs.

"We do not plan to force manufacturers to convert their branded generic drugs into non-branded ones. However, we are going to promote debranding," GS Sandhu, joint secretary, ministry of chemicals and petrochemicals, told Business Standard.

The final draft of the policy is ready and is being sent to the Cabinet for approval. The policy is expected by the end of this year.

The prime minister's pharma task force, in its report submitted two months ago, had recommended debranding of generics.

The recommendation had caused a furore in the industry, which said it would shift focus from doctors to the chemists. It was pointed out that in large parts of rural India, chemists were not educated enough to unravel complicated, similar-sounding names of generic drugs and, therefore, could administer wrong formulations.

In another significant step, the government has planned a slew of incentives and concessions for research and development. One of these is likely to be a 200 per cent tax rebate for a period of 10 years.

"To identify the eligible ones (companies), there will be criteria based on the number of patents applied for, international regulatory approvals, scientists, and investments in research and development," said Sandhu.

However, the parameters for concessions are likely to differ from the "gold standard" that the Mashelkar Committee had proposed.

The committee had said only those companies should be considered for incentives and exemptions whose R&D efforts engaged at least 100 scientists and involved a minimum expenditure of Rs 10 crore (Rs 100 million).