FDA surprise checks on, but DCGI will be kept in loop

Feb 17 2014, 05:55 IST
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India wants to observe first-hand the processes undertaken by the US Food and Drug Administration. Reuters India wants to observe first-hand the processes undertaken by the US Food and Drug Administration. Reuters
SummaryIndia wants to observe first-hand the processes undertaken by the US Food and Drug Administration...

their bid for compliance.

The focus will also be on “sharing of information relevant to a lack of compliance with accepted current GMPs, good clinical practices, or good laboratory practices”, as appropriate, by manufactures and sponsors of medical products and manufacturers of cosmetics in each other’s country, said the statement of intent.

India shipped 26% of its total pharma exports of $14.6 billion during 2012-13 to the US. The country’s pharma exports are set to soon surpass domestic drug sales in value.

Analysts said that regulators around the world work closely with each other to understand best practices. “In some highly regulated countries there is even a move towards harmonisation of good manufacturing guidelines and drug approval processes to ensure that there is no arbitrage between a stronger and a weaker jurisdiction,” said Sujay Shetty, pharma expert at PwC. However, it is early days in India for any modification of GMP guidelines to mimic those of US FDA, Shetty added.

US-based pharma giants have also been putting pressure on India to make its patenting regime “more liberal”. India’s patent law has provisions that make it difficult to patent incremental pharmaceutical drugs that are not necessarily better than existing therapies in terms of efficacy. The US is also sore over India not adopting a “data exclusivity” law that could prevent “unfair commercial use” of the information furnished by innovator drug companies with regulators by third parties.

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