The office of drug controller general of India is all set to introduce the practice of inspection of the manufacturing facilities of countries from where Indian companies are sourcing APIs and intermediates for their pharmaceutical production. This, a part of the import registration policy, is to ensure the quality of products coming into the country.
DCGI, Dr Surinder Singh said that the practice of auditing and inspection of manufacturing sites abroad will be in place very soon. “Our office is making all efforts to begin this in another two weeks' time. We will start it with one country each in Europe and in Asia. We have selected Italy in Europe and China in Asia to start with”, Dr Singh said. Once the pilot programme is successful, it would be introduced for all the countries.
The Central Drugs Standard Control Organisation (CDSCO) has already selected a pool of drug inspectors and has started the process of short-listing them to form a team of 15 to 20 inspectors who will be trained in accordance with the international standards to be sent for auditing and inspection of sites in those countries. The DCGI said that it is high time India too started inspecting overseas manufacturing sites to bring in more transparency into the drug approval system.
Dr Singh said that drug inspectors will soon be sent to visit the manufacturing facilities in foreign countries to conduct inspections to ascertain the quality of medicines being sourced by Indian companies.
He said that it is the responsibility of the indenting agents to make the manufacturers aware of the rules and regulations of the country. As of now they have poor knowledge of the Drugs & Cosmetics Act, poor understanding and interpretation of the drug rules of the country. In fact, at times, even their submissions are not complete. It is the responsibility of the indenting agents to make them aware of these laws and also to ensure that these companies follow the rules and regulations of the country if they want to do business in India.