Research Institute Proposes Online Registration Forum for Drugs in India
The Indian government is mulling a proposal from a research institute to launch an online registry of foreign and domestic drugs that would aim to improve transparency and public knowledge of distributed drugs.
Information on such a registry might include a drug’s batch numbers, chemical properties and distribution data that could let healthcare providers easily know where products are available, said KG Revikumar, director of Kerala Institute of Drug Studies. The institute was created by the Kerala Medical Services Corp., the central procurement agency for essential drugs under the Department of Family Welfare.
Prime Minister Narendra Modi has asked the country’s Ministry of Chemicals and Fertilizers and Ministry of Health to examine the proposal, Revikumar said.
Other industry observers say the initiative should focus on transparency in India’s regulatory decisions for approving drugs. This might include when the drugs were approved, by whom, name of manufacturer and official designation of bioequivalence, Vince Suneja, a founding partner at U.S.-India life sciences advisory firm TwoFour Insight Group, said.
He says such an online portal could be a step towards adopting a database similar to the FDA’s Orange Book or Drugs@FDA. Currently, there is very limited “official” transparent information available to the public on the drugs approved in India, Suneja added. — Jonathon Shacat
Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.