CDSCO Hiring 147 Inspectors to Beef Up GMP Compliance

India’s national drugs authority will hire 147 inspectors this year to ensure adherence to good manufacturing practices, but training will determine success, an observer says.

The new hires will inspect pharmaceutical facilities for their manufacturing processes, drug testing, storage methods and staff qualifications. They will also investigate cases of counterfeit or sub-quality drugs.

The announcement by the Central Drugs Standard Control Organization — part of a five-year plan — has been anticipated, says Vince Suneja, CEO of TwoFour Insight Group.

The plan, which runs through 2020, calls for creating 1,195 new posts, including 64 experts, although no more specific information is given. In fiscal 2014-2015, CDSCO used roughly 58 percent of its allocated funds while many job vacancies went unfilled, according to a parliamentary report.

The key will be whether the vacancies will be filled by competent personnel, Suneja tells IPRM. Training will depend upon programs offered by CDSCO, with support from the U.S. Food and Drug Administration’s India office.

The promise to hire a new set of inspectors should mean that India will be able more rapidly and effectively to police India-based pharmaceutical manufacturing, which will only benefit the more responsible drug manufacturers in India and the public, says Mark Barnes, a partner at law firm Ropes & Gray.

The FDA recently found multiple manufacturing process violations in a few India-based manufacturing plants, and this new initiative by CDSCO likely represents one governmental response to those citations, he tells IPRM. — Jonathon Shacat



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