Indian Regulators need to do more in case of Indian pharmaceutical companies

Indian generic drug manufacturers were in headlines from last year till date on account of constant alerts from international drug regulators. The Drug Controller General of India (DCGI), is struggling to ensure quality in the domestic market and feels that India is still not well equipped to match with the international standards as practiced in the US which is the largest market for drug manufacturers.

Recently the Indian team of the American Drug Regulator’s was at the DCGI office for discussion on the issues pertaining to Indian drug companies. According to Drug Controller General of India, Mr G.N. Singh, safety and wellness of the patients is the first priority and have to work with the American regulators in order to improve the situation of the Indian domestic drug companies. Mr. G.N. Singh also said that “the situation has to be viewed from an Indian perspective, rather than a direct comparison with developed markets and also said the states to strengthen practices to ensure safety of patients. According to him, Some of the 'Bimaru' states (a term for undivided UP, MP, Bihar and Rajasthan) have to step up but there are others like Maharashtra  and Gujarat which are doing a better job, from GMP (good manufacturing practices) perspective.

However several drug manufacturers in Maharashtra and Gujarat have continuously received warning letters and import ban from USFDA .Recently  a top pharmaceutical company was in news on account of deleting its lab data to pass the FDA tests. According to V K Subburaj, the government's secretary for pharmaceuticals, "It's a challenge to meet international standards. The number of officer under Indian regulators are also less, compared to foreign counterparts,". The Indian regulator has 1,200-1,500 officers whereas the FDA has approximately 13,000 officers. As per the experts 20,000 officers would be required to adequately inspect all drug facilities. India has almost over 10,000 manufacturing units for drugs. The experts also say that the Indian drug regulators were late in identifying the issues pertaining to Good Manufacturing practices.