The Central government is drawing a legal framework for over the counter (OTC) medicines, under which commonly used analgesics will be put on a specific OTC list while penalties will be imposed on pharmacies selling antibiotics and other high-risk drugs without doctor’s prescription.

“In the absence of a legal framework, chemists are selling some commonly used prescription-only drugs like paracetamol or those for cold and cough over the counter. Besides, some crucial drugs, mainly high-end antibiotics, are also getting pushed as OTC medicines, a senior Health Ministry official said.

Currently, there is no mechanism to recognise OTC medicines and all drugs not included in the list of prescription-only drugs are considered to be OTC drugs by pharmacists. But several prescription-only medicines, listed in schedules H and X of the Drug and Cosmetics Rules, are also easily available OTC without a doctors prescription.

To address this loophole, the Drugs Consultative Committee, headed by a joint secretary in the Health Ministry, has formed a sub-committee with a mandate to draw up a legal framework to regulate OTC medicines.

The sub-committee will submit its report within three months, the official said.

Once we have a notified list of OTC drugs, it will be easier to track those selling prescription only drugs without a prescription from registered medical practitioner. This will also help us create more awareness among consumers, the official added.

The move assumes significance in view of more OTC drugs in categories like mother-and-child care, weight management, dietary supplements and even cardiac care being introduced by pharma companies.

While all such products do not need doctors prescription, as per regulators many of them have therapeutic effect, and therefore, should be put under some kind of regulation.

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