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he $ 25- billion Indian pharma industry is going through intense regulatory scrutiny. Foreign drug regulators such as the Food and Drug Administration ( and European Medicines Agency have increased their inspections of Indian drug manufacturing plants that export medicines to those geographies. Individuals and civil society groups – both within the country and outside – are seeking better regulatory mechanism for Indian drugs manufacturers. In an exclusive interview with Business Today’s Joe C. Mathew, Drugs Controller General of India G.N. Singh says that India's drug regulatory mechanism is not as bad as it is often made out to be, though it may not mirror the systems that exist in the developed world. Edited excerpts: A citizen had recently approached Indian courts to re-draw the ‘archaic’ domestic drug regulatory rules. The complaint was that Indian regulatory system is in shambles. Do you agree? It is true that the Drugs and Cosmetics Act was framed in 1940, but that does not mean that it is inadequate to take care of issues related to safety, effectiveness and quality of the drugs. The overall governance of drug regulation is based on the rules under the Act. The Drugs and Cosmetics Rules are dynamic in nature. So the overarching framework may not have changed, but the rules are up to date. If you see our country in totality, and look at our regulatory system in an overall integrated fashion, you will find that our regulatory system is competent enough to meet the issues of quality, assess the overall effectiveness and overall patient safety. The issue, which people often flag, is the gap that exists between the USFDA and our drug regulatory system. It is a different issue. Depending on the social, economic and other factors, each country will have its own set of regulatory system. The fundamental thing that we need to look