For the first time, the Union government has proposed to introduce over-the-counter (OTC) pharmaceuticals in India by a change to the Drugs and Cosmetics Rules, allowing their retail sale without a doctor’s prescription. The Union Health Ministry has requested that the 16 pharmaceuticals, which include typical antipyretic medicines such as paracetamol 500 mg, certain laxatives, nasal decongestants, and topical antifungal creams, be put in the OTC drug category. The government has sought public comment on the proposed modification within a month.
A vast number of pharmaceuticals are widely available in pharmacies without a doctor’s prescription in India, however, the country’s drug regulations do not define OTC medicines. According to ministry officials, the Drugs Technical Advisory Board (DTAB), the government’s highest drug advisory body, approved the new OTC policy early this year. ‘ There was a long discussion on the pharmaceuticals allowed for the category after that, and to begin with, 16 medicines are planned to be permitted as OTC drugs in the country. We will later extend this category and add other drugs to the OTC drug list’, an official said.
Conditions
The draught notification states that the indicated medications can be offered over the counter without a prescription from a qualified medical practitioner only provided the maximum period of treatment or usage does not exceed five days and people visit a doctor if the symptoms do not resolve. Another requirement is that the drug’s pack size does not exceed the maximum dose indicated for five days and that each pack includes a patient information sheet. The proposal further specifies that the claimed indication shall be the same as that currently approved by the licensing authorities for each medicine.
Currently, no OTC policy.
Chinu Srinivasan, a drug and pharma specialist with the All India Drug Action Network – a patients’ rights organization – pointed out that OTC medications are not specified by the Drugs and Cosmetics Act of 1940 or the Drugs and Cosmetics Rules of 1945. ‘ Even the draught notice does not explain what OTC implies, nor does it provide a clear indication of the criteria used in selecting some pharmaceuticals as OTCs,’ added Srinivasan, who expressed astonishment that other commonly used treatments, such as oral rehydration salt (ORS), were not included in the list.
He also stated that pharmaceuticals that Accredited Social Health Activists (ASHAs) prescribe should be included in the list of OTC medicines, emphasizing that the choice of 16 substances recommended for OTC sale is incomprehensible. ‘It also serves the purpose of having an OTC list if pharmacists selling prescription pharmaceuticals are penalized through routine inspections and monitoring procedures,’ Srinivasan added.
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