Pharma firms divided on drug trial proposal
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.
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