India Pharma Outlook Team | Wednesday, 05 March 2025
India to finalize a report this month on the list of drugs to be switched from prescription-based to OTC status. The subcommittee formed to review their very major report before it goes to the DTAB has almost completed its editing process.
Dr. Anupam Prakash, chairman of the OTC subcommittee, noted that, besides pharmacies, general stores will also have their own share of OTC products included in this list. In fact, a number of pharmaceutical companies have appealed to the government to approve certain drugs to be OTC.
"The committee is working actively and we will soon finalise it", said Dr. Anupam Prakash without specifying the names of the medicines. He added that the committee wants to make sure that public health is not compromised, which is only a few commonly used drugs will be classified as OTC. "We are bothered about the public at large and not the products," he added.
The committee also had an interaction with various lobby groups, NGOs, and pharmaceutical stakeholders regarding concerns besides proper regulation of OTCs. Unlike the policies wielded by nations like the US, the UK and China, India does not indeed have a comprehensive set of regulations concerned with OTC distribution, marketing and consumption.
Although common medicines, like cough and cold remedies, as well as contraceptives, are able to be sold over the counter, there exists no proper definition of OTC drugs in India's Drugs & Cosmetics Act, 1940 or in its Drugs & Cosmetics Rules, 1945. This proposal is expected to take OTC medicines in India into proper definition and regulation.