Exclusive | Government proposes over-the-counter sale of 16 commonly used medicines

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The Union government, for the first time, has proposed to introduce over-the-counter (OTC) drugs in India through an amendment in the Drugs and Cosmetics Rules and allow their sale in the retail market without doctors’ prescription.

A draft notification issued by the Union health ministry has proposed that the 16 drugs, which include common antipyretic medicine such as paracetamol 500 mg, some laxatives, nasal decongestants and topical antifungal creams be included in the OTC drug category.

The ministry has asked for public feedback on the draft amendment within a month.

A large number of drugs in the country are easily available at pharmacies without a prescription from a doctor, but India’s drug laws do not define OTC medicines.

Officials in the ministry told Moneycontrol that earlier this year, the Drugs Technical Advisory Board (DTAB), the government's top advisory body on drugs, had approved the new OTC policy.

“After that, there was an extensive discussion on the drugs approved for the category and to begin with 16 medicines are slated to be permitted as OTC drugs in the country,” said an official. “Later, we will further expand this category and bring in more medicines in the OTC drug list.”

Conditions

The conditions mentioned in the draft notification say that the specified drugs can be sold by retail over the counter without prescription of a registered medical practitioner only if the maximum duration of treatment or use does not exceed five days and if the symptoms does not resolve, patients consult a doctor.

Another condition stipulates that the pack size of the drug should not exceed the maximum dose recommended for five days and each pack is accompanied with patient information leaflet.

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Also, the indication claimed should be same as already approved by the licensing authority for every drug, the draft also clarifies.

No OTC policy currently

Chinu Srinivasan, a drug and pharma expert with the All India Drug Action Network - a patients’ right body - pointed out that OTC medicines are not defined either by the the Drugs and Cosmetics Act, 1940 nor the Drugs & Cosmetics Rules, 1945.

“Even the draft notification does not define what OTC means not does it gives a clear indication of the choice of criteria used for picking some drugs as OTCs,” said Srinivasan, and expressed surprise that other routine used drugs such as oral rehydration salt (ORS) is not included in the list.

Stressing that choice of 16 drugs proposed for OTC sale is inexplicable, he also said that drugs that the Accredited Social Health Activists (ASHAs) prescribe should be in the list of OTC medicines.

“Also, the purpose of having an OTC list is served if pharmacists selling prescription drugs are penalised through routine inspections and monitoring mechanisms,” said Srinivasan.