The much-awaited auditing and inspection of manufacturing facilities in foreign countries by the Indian drug regulators to ensure quality of importing products will soon be a reality as the Central Drugs Standard Control Organisation (CDSCO) has finalised a three-member team for the pilot project in this regard. The first such inspection is expected to be held in the first week of May in China.
According to sources, the Drug Controller General of India (DCGI) Dr Surinder Singh has formed a three-member panel for the purpose and the documents for the visit, such as visas, etc, are being readied for it. The panel consists of Arvind Kukrety, assistant drug controller, CDSCO, C Manivillavan, drug inspector, CDSCO and Dr AR Singh, director at Regional Drugs Testing Laboratory (RDTL) Chandigarh.
Everything has been finalised and the delay is only due to the procedures like visas, etc, sources said. As per the initial plan, the panel was to do its first foreign inspection in the last week of April in China. But, due to procedural delays, now the pilot project will be launched in the first week of May, sources said.
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.
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.