OTC policy can boost drug access, market

In a step that could address a gap in India’s drug regulatory regime, a government-appointed three-member panel is mulling the idea of making commonly used cough and cold medicines, antacids, and fever-reducing drugs available ‘over the counter’ (OTC) at general stores. Many countries, such as Britain, the US and Australia, have well-defined guidelines for their sale and regulation.

In 2022, India allowed the sale of certain drugs without a prescription as part of a new OTC drug policy. Though the Drugs Technical Advisory Board, the top advisory board on drugs, approved the policy, it never saw the light of the day. Neither the Drugs and Cosmetics Act of 1940 nor the Drugs and Cosmetics Rules of 1945 define OTC medicines. Minus any rule, a drug in India is considered OTC unless it is specifically stated as a prescription-only drug. Since these medicines have not been classified as OTC, only chemist shops and pharmacies can sell them.

Convenience aside, making these commonly used medicines available at local shops has several benefits: first, it could improve access to common drugs in rural areas where chemist shops and doctors are not easily accessible. Second, it could limit the overuse of antibiotics and other prescription drugs, which are often ‘suggested’ by chemists to consumers. Third, a clear classification of drugs as OTC will allow pharmaceutical companies to expand their range of OTC products and market them effectively. Fourth, the classification will provide clear guidelines on what can be sold as OTC. Lastly, the new approach to non-prescription drugs should lead to better enforcement and compliance with requirements to limit the sale of Schedule H drugs ‘on doctor’s prescription only’. It’s truly an idea whose time has come.


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