[MPWG] Merits of Certification

JPS Kohli info at businesshorizons.com
Wed Dec 8 01:22:40 CST 2004


I am a pharmacist having dual interest in pharmaceuticals as well as medicinal plants so I might lack a bias towards one or the other. Two years back when I was participating in Supply Side West trade show in Las Vegas to promote two of our best-selling books - Quality Control of Herbal Drugs and GMP for Botanicals, I met a few people who laughed at the suggestion that such GMP norms or quality standards or the associated paperwork could become official requirement. A few months later the FDA released the GMP norms to be followed by the herbal manufacturers. I think they will be a lot more serious about the whole process now. A majority of the manufacturers however were quite enthusiastic about them.

Similarly, certification schemes I firmly believe are here to stay - like it or not. It's only a matter of time before people get their acts together and find the benefits (and the painful associated expenses as well) of such processes. Imagine if pharmaceutical companies started complaining about the standards they have to follow in the various pharmacopoeias - each would be making their own medicine in their own way and the consumers would find out the quality only after consuming the medicines produced by these manufacturers.

I once heard an apt phrase from a European manufacturer - The problem with standards is that there are so many of them - which really hits the nail on the head. I think over a period of time all such standards will coalesce together to form a comprehensive collection (maybe under government body like FDA in USA) where the beneficiaries will be the consumers at the first instance and the complying manufacturers later on. And just like we have nation-wise pharmacopoeias without much conflict, so too may be the case of herbal pharmacopoeias.

J P S Kohli (B. Pharm)
Business Horizons
Pharmaceutical Publishers
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