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Policy

India aims to improve drug quality

by K. V. ­Venkatasubramanian, special to C&EN
September 12, 2016 | APPEARED IN VOLUME 94, ISSUE 36

India has made it mandatory for all personnel employed in pharmaceutical manufacturing to complete a certification program. This is the first-of-its-kind government initiative aimed at substantially improving the quality of India’s pharmaceutical products and enhancing the skills of the industry’s workforce. Employees of pharmaceutical companies in India must complete the certification process by Jan. 1, 2018. “No person shall be employed in any pharmaceuticals/biopharmaceutical manufacturing units unless he has obtained a formal diploma or degree in the relevant area, or has been certified,” the Drug Controller General of India, G. N. Singh, said in a statement. The rapidly growing Indian pharmaceutical industry faces a huge shortage of skilled workers. The move comes as some of India’s drug companies face problems abroad, particularly in the U.S. and other regulatory markets, due to product quality concerns, poor manufacturing facilities, and improper documentation. India’s drug industry has been facing increased regulatory scrutiny by the U.S. Food & Drug Administration as reflected in an increase in warning letters and import alerts.

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