Pharma firms divided on drug trial proposal

Some allege that the move to amend the validity period is being taken up at the behest of multinational drug cos

A central government move to extend the trial validity period of new drugs from four to 10 years has divided the pharmaceutical industry.

All applications for manufacture of new drugs are required to be made to the central drug licensing authority for four years. And, require the applicant to do clinical trials and bio-equivalence studies. After four years, state licensing authorities can grant approval. The suggestion now is to extend this four-year period to 10 years.

“Extension will delay competition and hurt patients. It will seriously compromise not only growth of the national pharmaceutical industry but deny access to affordable medicines,” Indian Pharmaceutical Alliance Secretary General D G Shah wrote to the secretary, department of industrial policy and promotion.

According to Shah, the cost of trials and studies for a new drug application begins at Rs 1-2 crore. Many small manufacturers do not have expertise or can afford the investment. “Thus, only 10-15 formulators of 100 competing in the market seek new drug approvals from the central licensing authority,” he said.

The Organisation of Pharmaceutical Producers in India, representing multinational drug makers has welcomed the proposed amendment.

"This would be a step towards ensuring patient safety. We do not think such a provision can in any way be seen as a data exclusivity provision,” said Kanchana T K, director-general, Oppi.