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Health ministry to send 2nd team for inspection of manufacturing sites in China from Nov 20
Ramesh Shankar, Mumbai | Monday, October 24, 2011, 08:00 Hrs  [IST]

As part of its efforts to ensure that only quality products are sourced by Indian companies from abroad, the union health ministry will on November 20 send its second delegation to China for auditing and inspection of six  manufacturing plants there.

According to sources, a three-member delegation of the Central Drugs Standard Control Organization (CDSCO) led by Dr S Eshwar Reddy, assistant drug controller, will leave for China on November 20 to inspect a total of six diagnostics and bulk drug units there. B Kumar, assistant drugs controller, CDSCO sub-zonal office (Chandigarh) and Dr C Sokhey, senior scientist at National Institute of Biologicals (Noida) are the other members of the delegation which will be in China till November end.

This will be the second auditing and inspection of manufacturing facilities in China as the ministry earlier in May this year had sent a three-member CSDCO delegation to inspect the manufacturing sites there. During that two-week long pilot project from May 9 to 21, the CDSCO delegation had inspected five manufacturing sites in China which have been found to be in good condition.

This time also the inspections will be carries out in China only and the plans to inspect manufacturing plants in Italy has been deferred. Earlier, the ministry had elaborate plans to start the new practice with one country each in Europe and Asia --- Italy in Europe and China in Asia. But in the pilot project, the ministry sent the delegation to China only. The ministry has made plans to extend the auditing and inspection of all the manufacturing sites in all the foreign countries once the pilot programmes are successful.

The introduction of auditing and inspection of foreign manufacturing facilities by the Indian drug regulators was a long awaited practice, especially in the wake of the fact that even though the government had made registration of imports of drugs and pharmaceuticals into India made mandatory way back in 2003, it failed to bring the desired results as the inflow of inferior raw materials into the country refused to subside.

It was against this background the ministry earlier this year decided to introduce the practice of inspection of foreign manufacturing facilities.

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