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DCGI office ready to inspect Chinese API production facilities
Joseph Alexander, New Delhi | Friday, July 11, 2008, 08:00 Hrs  [IST]

Responding to the growing demand by the industry, the drug administration said it was willing to hold regular inspections on the Chinese facilities supplying active pharmaceutical ingredients to India and enforce import norms sternly, to improve the quality of Indian medicines.

The DCGI office maintained that it was ready to send the delegation of officials to make required inspections depending on the permission by the government in this regard. "We have funds to spare for the same and technically qualified personnel. The problem is with regard to getting approval from the Government,'' sources said.

The pharma industry has been demanding for on-site inspections of Chinese facilities and strict enforcement of registration norms for import, as the country depends on China heavily for API supply. Also after the Heparin controversy, many of the pharmaceutical raw materials produced by China have come under a cloud across the developed world.

Reports also said Australia, United States and Europe would jointly inspect factories in countries like India and China to ensure safety standards. The US Government recently announced that it would work with Australian and European officials to coordinate their inspections and share information, thereby covering a wider territory and more foreign facilities. The pilot programme will initially focus on makers of active pharmaceutical ingredients, media reports said.

The authorities admitted that it was the right time for India to mount inspections as China was having rough time to sustain its edge in API supply to the world and also to revive the bulk drug industry in the country. The DCGI office said it would put forward the proposal as a demand from the industry and work towards getting it approved at the earliest.

Recently at an open-house here, the manufactures in North and the Pharmexcil had made such a request to the DCGI to send his personnel to China for carrying out inspections. Besides, SME Pharma Industries Confederation (SPIC) also made a representation formally to Chemical Ministry to send joint team of officials from DCGI office and technical officers from the Pharma department to China as many developing countries like Ghana and Nigeria were also doing the same.

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