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India to Expand Inspections of Foreign API Manufacturing Facilities - 05 Dec 2013

India’s drug regulator will soon expand its inspections of foreign manufacturing facilities that supply active pharmaceutical ingredients (APIs) to Indian drug companies. According to the Drug Controller General of India (DCGI), the inspections will focus on China, which supplies nearly 60 percent of India’s APIs.

Chinese APIs are much cheaper than Indian ones, but regulators fear that many are of inferior or questionable quality. According to the US Food and Drug Administration, India’s drug industry is at risk for serious adverse events because it sources so many of its APIs and excipient products from unauthorized Chinese manufacturers.

The Indian DCGI announced in 2012 that it would open an overseas inspection office in China, as part of a greater $480 million project to improve India’s drug regulatory system. But the office did not open according to its original March 2013 deadline, although it has since been “cleared” by Chinese officials. Once the office does open, the DCGI has said that it will conduct more on-site inspections of API manufacturing facilities in China.

In 2012, India imported $4.6 billion worth of APIs, up from $2.9 billion in 2011.


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