Govt To Take Action Against Chemists For Selling Antibiotics Without Prescription

Commonly used medicines for flu and pain relief that are available over the counter (OTC) despite some being "prescription only," will now be put on a specific OTC list, while a legal framework will set out penalties on sale of antibiotics and other high-risk drugs without prescription, a government official said today.

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Medicines for cough, cold, flu and pain relief, such as paracetamol, ibuprofen and other analgesics, may soon be available OTC without prescription. But while the Centre is set to categorise more drugs as OTC, it is also drawing a legal regulatory framework to avoid misuse of high-risk drugs, especially antibiotics. Once these are in place, the government plans to make it mandatory for companies to label such drugs 'OTC' on the package, making it easier for consumers to distinguish, an official said.

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"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 official said.

The indiscriminate use of antibiotics, sometimes without prescription, has led to a rise in immunity against drugs, creating serious problems in managing infections. The government has been pressing for more cautious use of antibiotics.

Currently, 'OTC' has no legal recognition in India and all drugs not included in the list of 'prescription-only' drugs are considered to be OTC drugs and so legally allowed to be sold over the counter by pharmacists. However, several 'prescription-only' medicines, listed in Schedules H and X of the Drug and Cosmetics Rules, are easily available OTC without a doctor's prescription. The Centre is now trying to address this loophole by drawing a legal framework for OTC medicines.

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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 drugs. The panel will also study international models and list of OTC drugs in other countries for reference. According to the official, the committee has been asked to draft specific provisions to regulate sale of OTC drugs in the country. This will include provisions for penalty and punishment against those selling prescription drugs over the counter.

"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 said.

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The move also assumes significance as pharmaceutical companies are launching more OTC products in categories such as mother-and-child care, weight management, dietary supplements and even cardiac care. These products involve large margins, and experts say these segments are expected to witness rapid growth because of lifestyle diseases and consumers turning health-conscious.

While all such products are sold OTC without a doctor's prescription, regulators say many of them have therapeutic effect, and therefore, need certain regulation under the drug law.