E-DRUG: Training in GMP for developing countries (2)
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As per Schedule M of the Drugs and Cosmetics Rules of India, all pharmaceutical manufacturers are legally supposed to comply with GMP. However in practice not even 5% of over 26,000 drug companies operating in India do so.
Even those companies whose manufacturing facilities do comply do not produce all their formulations themselves but outsource them to others which may not be GMP compliant. Hence each batch of each formulation will need to be checked to (a) ascertain the real manufacturer and (b) if it is GMP compliant.
Dr. Chandra M. Gulhati
Editor, MIMS
(Monthly Index of Medical Specialities)
e-mail: indianmims@yahoo.co.in
seeemgee@yahoo.co.uk