OTC medicines: Drug advisory body gives in-principle approval

Pharmacists will soon be empowered to dispense new category of OTC drugs such as anti-allergy and antipyretic medication without a doctor's prescription

Teena Thacker
Updated20 Sep 2017
Photo: Hemant Mishra/Mint
Photo: Hemant Mishra/Mint

Soon, pharmacists will be able to dispense drugs for minor conditions without a doctor’s prescription. The government’s advisory body on drugs—the Drug Consultative Committee (DCC)—has approved a proposal to introduce a new category of over the counter (OTC) medicines such as anti-allergy, antipyretic (for fever) and anti-emetic (for vomiting and nausea) drugs, which pharmacists will be empowered to dispense without a doctor’s prescription

The list includes muscle relaxants, decongestants, anti-inflammatory drugs, antacids, external preparations for skin and hormonal contraceptives.

The DCC on Monday constituted a subcommittee comprising of various health experts to examine the modalities and shortlist the drugs that can be brought under the category of OTC.

Mint had on Monday reported that the Central Drugs Standard Control Organization (CDSCO), the regulatory body for pharmaceuticals and medical devices, was considering introducing provisions in the drugs and cosmetics rules to include the new category of OTC drugs.

“The DCC chaired by the Drug Controller General of India gave its in-principle approval to the proposal. The subcommittee will work on the modalities and will present its report before the Drug Technical Advisory Board (DTAB)—the chief advisory board—on drugs next month,” an official aware of the development said on anonymity.

Once approved by the DTAB, the proposal will be sent to the ministry of health and family welfare for final notification.

The move is expected to save patients the bother of having to visit their doctor for every common ailment. But there is a limitation—pharmacists will not be allowed to prescribe habit-forming drugs or strong antibiotics.

Over-the-counter drugs are common in many countries. Currently, in India allopathic drugs which are safe to be dispensed mostly fall under Schedule H and H1 and require a prescription, according to the Drugs and Cosmetics Act, 1940.

“International practices show that there is a separate category of drugs which are harmless and safe enough to be dispensed without any prescription. We want to bring this concept in India too which will help people skip doctor’s visit for common ailments. This will make access to drugs easier for not only those living in urban areas but those living in rural areas and mostly dependent on quacks. The pharmacists are qualified to provide these services and have been underutilized,” added the official cited above.

Kailash Gupta, president, All India Chemists and Distributors Federation, said that the expanded powers of pharmacists will increase convenience and accessibility for “those who need refills or have a minor condition”.

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