Can India’s Drugs Meet International Standards?

Convertech, Inc.

After years of quality issues and export bans, the Drug Controller General of India (DCGI) is set to draft an amendment to existing pharmaceutical manufacturing laws to raise drug manufacturing quality to meet international standards.

Within the next six months, the DCGI will push a proposal before the government to amend the Drugs and Cosmetics Act of 1940, and the Drugs and Cosmetics Rules of 1945.

The goal, according to the drug controller of India, is to revisit present laws and bridge the gap between Indian manufacturing practices and the established WHO good manufacturing practices.

The DCGI plans to evaluate current regulations and GMPs in the US, Europe, Canada, Japan and Australia as part of the process. Last year, India’s Central Drugs Standard Control Organization issued new guidelines for state inspectors on how to prepare for and conduct GMP inspections of drug manufacturing facilities. The Indian pharmaceutical industry–which has the the largest number of FDA-approved manufacturing facilities outside the U.S–has been plagued with import alerts and quality issues from prominent manufacturers such as Wockhardt, Sun and Ranbaxy.

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