Pharmacists community question IPC members' representation in US Pharmacopoeia
A section of the pharmacy professionals are up in arms against the representation of some of the prominent Indian pharmacists in the US Pharmacopoeia-India Pvt Ltd. when they are already members of Indian Pharmacopoeia Commission.
Although the role of IPC members in the Indian Advisory Group (IAG) of U S Pharmacopoeia-India Pvt. Ltd is of honorary nature, there is a conflict of interest as these members are holding posts both in USP and IPC. Interestingly, the chairman of the scientific committee of IPC himself is in the IAG of USP.
This is at time when the "semi-autonomy" of the Indian Pharmacopoeia Commission (IPC) and "lack of adequate representation" for scientific community in IPC continue to be topics of heated discussion among pharmacy professionals.
The IAG comprises Nitya Anand, Member, Indian Pharmacopeia Commission, Humayun Dhanrajgir, former CEO, GSK India, Milind Joshi from J.B. Chemicals, Swati Piramal, Director, Nicholas Piramal Group, P. Rama Rao, Director, NIPER, Ajit Singh, Chairman, ACG Worldwide and N.Vaghul, Chairman, ICICI Bank.
The IP experts who were against IPC members joining IAG of USP said that the members whose names figures in both IPC and USP India owe an explanation to the IPC for their decision. The members, when contacted said that they had obtained prior permission from the authorities before agreeing to be part of USP's IAG. "I have agreed to be part of IAG before the government notification made be a responsible member of IPC. I don't find any conflict of interest as both are bodies of scientific nature. If there is something, I will only be glad to resign from my advisory role in USP," a member concerned assured pharmabiz.
The disgruntled members said that IPC is a very important body responsible for setting standards for drugs manufacturing in India. They feel that the standards adopted by IPC and USP may not be the same and for the same reason there could be a conflict of interest if it is represented by the same persons. USP India had incorporated IAG to assist the organization in addressing national and regional issues related to the establishment of USP-India.
The pharma professionals who consider the "double role" of these members "insignificant" said that there could not be any conflict of interest in scientific matters. "Indian Pharmacopoeia Commission is not a purely government body. It draws members from the industry as expert consultants during the preparation of monograph. In fact every act of monograph preparation is being carried out with the assistance and active participation of the private industry. Will that be projected as conflict of interest? If you can permit private industry, including representatives of multinational companies in your standard setting process, why should you blame your experts for being part of another scientific body?” they ask.
As pharmabiz had reported earlier, USP India proposes to provide USP's broad range of Pharmacopoeial services to USP customers in India and surrounding countries. It is to have a state-of-the-art laboratory and would involve experienced Indian scientists in the standards-setting activities of USP. The USP-India site is to ensure that USP works more closely with Indian and regional constituencies, including the Indian Pharmacopoeia and Indian pharmaceutical manufacturers to promote the manufacture of good-quality, safe, and effective medicines and dietary supplement ingredients and products for the US market and elsewhere. IP Commission is also meant to take up a similar task of cataloguing, standardisation and preparation / maintenance of the reference standards. It intends to keep pace with the rapid developments taking place in the world of drugs and pharmaceuticals and aims at functioning as a dedicated organization that can look into the method of preparation, characterization and standardization of reference standards of bulk drugs and their impurity profile of related substances.