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Panel to study role of regulators in pharma

September 08, 2003 15:30 IST

The government will soon constitute an expert group to prepare the future roadmap for National Pharmaceutical Pricing Authority in the product patent regime, Union Fertiliser and Chemical Minister Sukhdev Singh Dhindsa said.

"We will set up an expert committee within the ministry to chalk out the future role of NPPA in the product patent regime as also prepare a growth strategy for the industry," he said.

India will have to put in place the product patent regime from January 1, 2005 in compliance with its Trade Related Intellectual Property Rights obligations at the WTO for which the Patent Act will have to be amended.

The government has already initiated the consultation process for that.

Apart from the implications for the chemical and pharmaceutical industry, this amendment will also have implications for pricing of drugs, medicines, their availability and public health issues.

Dhindsa said the expert group would go into minor details of what the implications would be for the industry and regulatory agencies and suggest ways and means to direct their future growth.

Asked if the government had contemplated setting up a body similar to US Food and Drug Administration that could address all regulatory issues, the minister said the issue would be examined by the committee.

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