Indian Drug Regulators Complete First Ever Auditing & Inspection Of Mfg Plants In China.

The union health ministry's first ever auditing and inspection of manufacturing facilities in foreign countries ended on a happy note as the  three-member delegation from the Central Drugs Standard Control Organization (CDSCO) returned to the country after inspecting manufacturing facilities of five pharma companies in China which have been found to be in good condition.

Senior officials in the health ministry said that though the Indian delegation was to inspect six companies in China in this pilot project, they could inspect only five companies as one company, Chongiqing Daxin Pharmaceutical Company, did not allow the Indian drug regulators to inspect its premises and manufacturing facility. The ministry is seriously contemplating to cancel the exporting licenses of this company, sources said.

Located in China's Beibei district, Chongiqing Daxin Pharmaceutical Company is a bulk drug exporter to India.

Officials said that the two-week long inspection from May 9 to 21 at five manufacturing sites in China by the Indian team was a good experience as all the companies had cooperated well to inspect their premises. The pilot project has concluded well, and that will give a boost to the Indian drug authorities efforts to make it a routine affair to ensure the quality of products being sourced by Indian companies from abroad, officials said.

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 under this background that the ministry decided to introduce the practice of inspection of foreign manufacturing facilities. Accordingly, the Drug Controller General of India (DCGI) Dr Surinder Singh formed a three-member panel, consisting of Arvind Kukrety, assistant drug controller (CDSCO), S Mannivannan, assistant drugs controller (CDSCO) and Dr AR Singh, director at Regional Drugs Testing Laboratory (RDTL) Chandigarh, for the pilot project.

Earlier, the DCGI had made plans to start the new practice with one country each in Europe and Asia --- Italy in Europe and China in Asia. Once the pilot programmes are successful, it would be introduced for all the countries. However, the ministry did not so far finalise the visit to Italy for inspection of manufacturing facilities there.

Source : pharmabiz.com