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Initiating better moves: Reforms and additions to existing pharmaceuticals systems in India

None can deny at least one good effect of Indian and foreign pharmaceuticals collaborating; quality systems are now a major concern. It is a compulsory Good Manufacturing Practices (or, GMP) act - Schedule M of the Drug and Cosmetics Act (DCA).

It lists certain parameters – or, should we say boundaries – the factory premises, materials, plant and equipment have to stay in. Added details are too intricate to be discussed within limited words; let’s know it applies on low volume injectable and high volume parenteral as much as on APIs, tablets and capsules. With Schedule M, higher aspects of quality assurance are guaranteed, so are inspection and audits. It is wrong thinking of it as a constraint; GMP compatible quality assurance guides for the best yields also as GLP (Good Laboratory Practice) and GCP (Good Clinical Practices). These comprise specifications and samplings of every innovation; their test results and related documentation, release procedures, and more. Unless DCA okay all points, licenses can’t be granted for any type of drug manufacturing. However, for vaccines, critical IVD kits and r-DNA derived drugs, an authorization of the Drug Controller General of India (DCGI) prior to licensing is a tougher criterion to fulfill.

At the top are pharmaceutical companies like CIPLA, Ranbaxy and Dr Reddys. Their collective revenue now exceeds 25,000 crore INR, a flat 27% increase from last year’s. It is anticipated to get global by 2014, fetching around $16,000 million. The major players in the sector are Ranbaxy (revenue INR 42 billion), Dr Reddys Laboratories (Revenue INR 41.7 billion), CIPLA (Revenue INR 39 billion), Sun Pharma (Revenue INR 26 billion), Lupin Labs (Revenue INR 23 billion), Aurobindo Pharma (Revenue INR 21.5 billion), GlaxoSmithKline Pharma (Revenue INR 18.5 billion), Cadila Healthcare (Revenue INR 17 billion), Aventis Pharma (Revenue INR 10.5 billion) and Ipca Laboratories (Revenue INR 10 billion).