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improving access to medicines

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Hello,

We were on the point of discussing role of FDA.

As is true with all legal issues , the rules if implemented in the true spirit , we will definitely see benefits.We have been discussing under several topics about the proliferation of pharmaceutical substances in the market and the number of me-too/ irrational medicines. If we stick to our NEML, the resources would be judiciously used for their manufacture which would be available at affordable costs.

I went thru information on net and came across an exhaustive paper by world bank on improving access to medicines in developing countries.The economics of production, procurement, distribution are discussed in depth but since most of it may not interest our group I desisted from posting it as attachment.

Just a few salient points from that paper follow, some of those would definitely boost our morale.

In India there are many thousands of pharmaceutical manufacturers, most of which are small and have quite a specialized technology base.

Leading Indian companies are undoubtedly more advanced in terms of their technical and managerial capabilities

The main difficulties domestically lie in myriad layers of bureaucracy and associated corruption.

Chemicals industry has been able to develop highly specialized manufacturing

capabilities, covering almost the entire range of modern medicines from basic antibiotics to HIV/AIDS drugs and Viagra.

§ Leading companies, such as Ranbaxy, Dr Reddy’s, Sun Pharmaceuticals and Lupin have patiently invested in manufacturing facilities that meet the exacting EU and US Good Manufacturing Practice (GMP) and built strategic alliances with US and EU generic marketing companies achieving dramatic growth in export sales of active ingredients to the USA and Europe.

§ India has almost 62 USFDA approved plants and 35 drug master files.

When we consider the huge potential of pharma industry, we wonder why still our patients do not have access to medicines. The fault lies not in production, but definitely lies in management, distribution, policy framing and implementation, and information dissemination.

More posts are invited on areas where corrective measures can be taken.

kunda

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