The website of Central Drug Standard Control Organisation (CDSCO) in New Delhi clearly says that this organisation has no role in testing the Drugs and Drug Manufacturing in India. The zonal labs under its control only test drugs submitted. This is the finished product. They do not verify manufacturing process. In all pharmaceutical manufacturing, the quality of the finished product depends clearly on following the correct manufacturing processes. The zonal labs under CDSCO control test drugs submitted by a State or Central Government Agency. They have neither the man force or material to verify manufacturing processes of the various companies in their zone. They do not have a mechanism to proactively check drug quality. Further, the regulation is as per an ancient 1940 law which mandates all products found defective must be further verified in the Central Drug Lab in Calcutta. This is seen in the latest verdict of the high court of J&K regarding a 2009 case against well-known pharma company. On the other hand, if you check the website of the Medicines & Healthcare Products Regulatory Agency (MHRA) of UK it says that it proactively checks all the manufacturing processes. The functions of MHRA include operating a quality surveillance system to sample and test medicines to address quality defects. MHRA has inspection teams and does proactive monitoring. In 2007, more than 500 defects related to medicines were reported to the MHRA, resulting in the issue of more than 30 drug alerts. Such a regulatory regime is missing in India. In the USA, the FDA ensures the quality of drug products by carefully monitoring drug manufacturers’ compliance with its Current Good Manufacturing Practice (CGMP) regulations. The CGMP regulations for drugs contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product. The regulations make sure that a product is safe for use, and that it has the ingredients and strength it claims to have. FDA can issue a warning letter or initiate other regulatory actions against a company that fails to comply with Current Good Manufacturing Practice regulations. Failure to comply can also lead to a decision by FDA not to approve an application to market a drug. In India whenever there is a discussion regarding the need to reduce the costs of drugs, the need to use generic drugs and the presence of the largest generic drug manufacturers are in India, the absence of a regulatory body in India for proactive checks on drugs and drug manufacturing is never discussed. Why is this not discussed at all? India which the largest generic drug manufacturing country must have a Central Government Agency to check whether good manufacturing processes are followed; only then I will believe the generic drugs. Till then I shall adhere to famous multinationals who have a stake in other countries and will lose their reputation if found to be wanting in good manufacturing practice in India.
Why no generics