Notwithstanding DCGI Dr Surinder Singh's public announcement on January 7 this year that his office (CDSCO) will 'very soon' start auditing and inspection of foreign manufacturing facilities to ensure quality of importing drug materials, the CDSCO is yet to introduce this long overdue practice, thanks to the indifferent attitude of the concerned authorities.
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 is making all the efforts to begin this practice in another two weeks' time. We 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.
But even after almost four months of his public announcement, the DCGI is yet to introduce the system which has been pending for several years. Inspection of manufacturing facilities is a standard practice followed by most of the drug producing countries for ensuring quality of raw materials. Drug registration rules have provided adequate powers to DCGI to inspect foreign manufacturing facilities before clearing the import applications. Yet, no inspection of manufacturing sites of exporting companies is being carried out by the CDSCO officials as yet.
Introduction of auditing and inspection of foreign manufacturing facilities is significant as the practice will go a long way in ensuring the quality of foreign drug materials. Even though the union health ministry 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.
Though 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 events especially during the last couple of years have proved that the legislation could not prevent the inflow of poor quality raw materials into the country, especially from China. Experts believe that the major reason for this is the delay in introducing the practice of auditing and inspection of foreign manufacturing sites by the Indian regulatory authorities.