Mumbai: When you find that the quality standard mentioned on a US multinational drug maker’s AIDS drug label reads Indian Pharmacopoeia, or IP, next time, don’t be surprised.
It’s official now: The US drug industry would follow the standards for HIV/AIDS drugs as per the quality parameters prescribed in the drug standards manual prepared by the Indian Pharmacopoeia Commission.
By expanding the scope of a cooperation deal signed in 2006 between the US Pharmacopoeia and the commission, the US will be now publishing monographs, or a set of referral standards, developed by IP for about 51 anti-AIDS drugs. The 2006 deal was renewed by the US early this month, focusing on the adoption of AIDS drug monographs and also for sharing such standards referred in the IP for herbal drugs.
The US will publish the anti-drugs monographs from the commission in its editions, said US Pharmacopoeia India Pvt. Ltd’s vice-president (international) Kumud Sampath. “It may be more updated with appropriate validation processes...”
Pharmacopoeia is the drug standards manual for the industry published periodically by different countries to help drug manufacturers as well as the regulators to follow the parameters for making a standard drug. Currently, the US Pharmacopoeia and British Pharmacopoeia (BP) are the two widely referred pharmacopoeias in the world. IP is comparatively new in the world and directly under the government control so far.
The US standard, which has been followed by drug manufacturers, not only in the US, but also in several other countries in the world, didn’t have monographs for antiretroviral drugs until now.
Though the US has developed and owned majority of the HIV/AIDS drugs sold in the world, “a strict patent regime there made USP’s task to develop monographs for such drugs difficult,” says the Indian commission chairman, Nitya Anand.
A drug monograph in the pharmacopoeia contains details of material quality and specifications, validation and composition processes, manufacturing processes, use of colours and other ingredients, information regarding dosage, stability, etc., and the drug release pattern among others.
Incorporation of Indian monographs as the quality standards in the US standards would make compliance with this quality standard recognized almost across the globe. “Since India is the factory for cheaper generics for the word market, this recognition would definitely help Indian generic companies to get easy approvals in other markets without changing its manufacturing standards,” said a senior research executive working with a multinational group engaged in drugs and nutritional products, who doesn’t want to be identified.
India Pharmacopoeia Commission, which has been given full autonomy from the government last week, almost three years after it was established in 2005, has been very aggressively pursuing two major projects: The compilation of HIV drugs monographs and for herbal drugs. The commission published both these sets in two separate addendum last year to its edition that comes out every five years.
Anand said British Pharmacopoeia is also talking to the commission for sharing these two sets of monographs for its editions.
The Indian commission had in 2005 formed task forces involving industry experts to validate various manufacturing processes and quality standards adopted by different drug makers to prepare these monographs.