Aiming to ensure quality of importing pharmaceutical products into the country, the Central Drugs Standard Control Organisation (CDSCO) has at last introduced the much-awaited auditing and inspection of manufacturing facilities in foreign countries. A three-member CDSCO team led by Arvind Kukrety, assistant drug controller, CDSCO, has already left for China in this regard.
According to CDSCO sources, the three-member team will audit and inspect three Chinese companies in the pilot project. The team, including C Manivillavan, drug inspector, CDSCO and Dr AR Singh, director at Regional Drugs Testing Laboratory (RDTL), Chandigarh, left the country for China on May 7. The team will be in China for three weeks and will inspect three companies. However, the authorities did not disclose the names of these companies.
Earlier last year, Drug Controller General of India (DCGI) Dr Surinder Singh had finalised the three-member team for the pilot project in this regard.
Introduction of auditing and inspection of foreign manufacturing facilities is significant as the practice will go a long way in ensuring the quality of importing products. Even though the union health ministry had made registration of imports of drugs and pharmaceuticals into India 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.
The objective of bringing this rule in 2003 was to bring an end to the entry of poor quality APIs originating from various countries particularly from China through a scrutiny of import applications. Subsequent developments especially during the last couple of years have proved that the legislation could not alone prevent the inflow of poor quality raw materials into the country. Experts believe that the major reason for this is due to the delay in introducing the practice of auditing and inspection of foreign manufacturing sites by the Indian regulatory authorities.
The incumbent DCGI Dr Surinder Singh was very keen to introduce the much needed practice. Speaking to the captains of Indian pharma industry on the occasion of the 49th annual day celebrations of the Indian Drug Manufacturers Association (IDMA) in Mumbai on January 7 this year, the DCGI had said that to ensure the quality of products being sourced by Indian companies from abroad, especially China, his office will very soon introduce the practice of inspection of the manufacturing facilities in other countries by the Indian regulators.
“Our office will start the new practice with one country each in Europe and Asia. We have selected Italy in Europe and China in Asia,” Dr Singh had said and added that once the pilot programmes is successful, it would be introduced for all the countries.