[MPWG] Merits of Certification

pankaj oudhia pankajoudhia at yahoo.com
Wed Dec 8 01:34:09 CST 2004


'A majority of the manufacturers however were quite enthusiastic about them.'
 
I feel that most of them are well established maunfactures.There are many manufactues (in thousands) for them these GMPs are not easy to adopt.Possibly the GMPs are not prepared considering their requirements.Now these  small manufacturers have only two options.First to close the businees and second to sell their formulation to big manufactures or merge with it.
 
In India many manufacturers are in dilemma and unfortunately no one is on their side.I am now feeling by the messages of Fred that the situation is more or less same around the world.
 
regards
Pankaj Oudhia
http://www.pankajoudhia.com 
 

JPS Kohli <info at businesshorizons.com> wrote:
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
G-59, Masjid Moth, GK-2
New Delhi - 110 048, INDIA
 
Ph: 91-921206 1554
Fax: 91-11-5163 7296, 2921 1676
E-Mail: info at businesshorizons.com
Alternate: businesshorizons at yahoo.com
Web Site: http://www.businesshorizons.com
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