As a follow-up to banning the import of raw materials from 10 Chinese drug companies for supplying products without having the mandatory drug manufacturing standards, the Drugs Controller General of India (DCGI) has proposed to implement overseas inspection of manufacturing sites soon. The move is to make sure that there are no incidences of regulatory lapses from any foreign drug companies who import raw materials to India.
Soon, drug inspectors will be sent to visit the manufacturing facilities in foreign countries to conduct inspections to ascertain the quality of medicines being sourced by Indian companies. DCGI Dr Surinder Singh said that his department will select a pool of 64 drug inspectors from the country and once that is done they will short-list a cluster of the best 15 to 20 inspectors who will be trained in accordance with the international standards and send for the auditing and inspection of manufacturing sites in foreign countries. The DCGI said that it is high time India too started the practice of inspecting the manufacturing sites to bring in more transparency into the drug approval system.
Stressing the need for overseas inspection, Dr Singh 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 and Cosmetics Act, poor understanding and interpretation of the drug rules of the country. In fact, surprisingly 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."
Dr Singh feels that in order to ensure this, first priority should be given to educate indenting agents about the laws of the nation. Educating them about the regulatory laws in the country will, in turn, will help in better regulations and fast registrations of the pharmaceutical ingredients. He urged the indenting agents to work along with the regulators and have more one to one interaction with the drug authorities so that they can discuss the problems faced by the indenting agents and the manufacturers and work it out in a more organised manner.
He clearly implied that importing drugs or raw materials without licence or NOC into the country is an offence and that his office won't tolerate any unlawful activities that may put the image of India into question. "We are pondering over the idea of confiscating and destroying the raw materials and drugs that are imported into the country without valid licenses or NOC and also on putting a stop to re-export of such raw materials."
At present the drugs or the raw materials that are imported into the country without licence or NOC are re-exported to the country of its origin, but it seems that soon this practice would come to an end. DCGI informed that his office plans to bring in the same rule for the exporters also.