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4 Nov 2016

New Drug Regulation in India: extension of new drug validity period from 4 years to 10 years

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Present Scenario:

  • As per current provisions, an application for a ‘new drug’ is approved only by the central drug regulatory agency for four years.
  • No other applications are approved during this period.
  • The state licensing authorities can clear the drug following the expiry of the four years enabling generic competition.
  • And, for approval the applicant to do clinical trials and bio-equivalence studies. After four years, state licensing authorities can grant approval.

Proposed Plan:
Central Government has proposed is to extend this four-year period to 10 years.

It refers to protection of clinical trial data to be submitted to regulatory agencies to prove safety and efficacy of a new drug. Data exclusivity automatically blocks generic drug manufacturers from relying on the data to get their products approved for a limited term. 


Review of Proposed plan:

This extension will definitely delay the competitions by delaying entry of generics into the market. So, there are critics for the rule –

“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. 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.

OPPI: Organisation of Pharmaceutical Producers of India.

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