Government Approves Drugs & Cosmetics Amendment Bill in India

India boasts of over 80 US FDA-approved plants, the largest number in any country other than the US. But even as these plants are said to be in compliance with the exacting standards set by the US FDA, there is absolutely no guarantee that all of India’s over 20,000 pharmaceutical manufacturing units relentlessly employ the good manufacturing practices (GMP), as revised by India’s drug regulator some three years ago. The fact that some hundred odd inspectors across the country are supposed to verify at frequent intervals the GMP compliance of these 20,000 units itself tells the story.

That is just about the plant quality and exactitude of manufacturing processes many Indian drug units follow. More precarious are the systems of material sourcing (procurement of active pharmaceutical ingredients or bulk drugs). Over 350 bulk drugs are indigenously manufactured and some 200, which include many that are also indigenously manufactured, are imported from China and Eastern Europe, among others, even as the country is also a major exporter of bulk drugs.

The quality of pharmaceutical products could also degenerate owing to inept handling and poor storage facilities at chemist shops and other retail outlets. It is obvious that large number of pharmacy stores in India care a damn for the good pharmacy practices (GPP) prescribed by the government. Storage requirements of biological products, intravenous fluids and vaccines should ideally be more stringent (with specified temperature controls etc.), but there are serious doubts as to whether these requirements are strictly and invariably met. While public sector healthcare centres are a sorry spectacle, even the private sector is largely going scot-free for laxity on this front.

Regulatory experts in India have, in the last few years, turned increasingly vocal on the need for bolstering pharmaco-vigilance (the regulatory term for monitoring, documenting and auditing of adverse reactions caused by new drugs in the years shortly after their market launch). Although some guidelines for adverse drug reaction (ADR) monitoring were issued a few years ago, it is indubitable that these are not followed in right earnest.

ComplianceOnline is bringing one day conference on Complying with GMP and cGMP Requirements – Streamlining Quality Assurance & FDA Compliance”

Source: Business Standard

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