India sending inspectors on facility visits with global peers – FiercePharma Manufacturing

Over the past year India has begun to face up to the reality that its regulatory machinery is insufficient to enforce quality standards, leading authorities to commit to hiring more inspectors. Another piece of the plan has been unveiled, with the Central Drug Standard Control Organization CDSCO revealing Indian inspectors are tagging along on inspections run by their international peers.

CDSCO plans to double its headcount and add laboratory capacity by the end of 2017, but there is little benefit to having 1,000 inspectors unless they know how to assess if a plant is following good manufacturing practices. In the last financial year CDSCO ran 17 training programs for inspectors, Pharmabiz reports, and has worked with the FDA on four GMP workshops on topics including process validation and enforcements. To support these efforts, CDSCO is sending its inspectors into the field with their global peers.

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