New rules on cards to govern OTC medicines

If you have fever, you need to go to a pharmacy to get even a paracetamol, a common drug for fever and pain. But, the government plans to soon make such drugs available at local retail outlets, with their labelling containing important information — preferred dosage and side effects — in local languages.

This is expected to help people in rural and far-flung areas, where pharmacies are rare.

“A new schedule is likely to be created under the Drugs and Cosmetics Act for OTC (over-thecounter) drugs so that these commonly used medicines that are not ‘prescription only’ and are relatively safe to use can be governed,” said a senior government official who did not want to be named.

He added: “There is a need to make such drugs available to more people. This will reduce the cost of treatment.” The official said many people preferred to self-medicate instead of going to a doctor, which is expensive for them.

Paracetamol is an OTC drug. There are no norms at present to regulate these.

Making such essential drugs easily available is important, especially because in India there is less than one doctor per 1,000 people. Also, nearly 74 per cent of doctors in the country cater to a third of the urban population.

The government, however, is cautious to ensure that the regulations are stringent enough to prevent misuse or overuse of these drugs, which might compromise safety of patients.

“There could be multiple categories of OTC drugs depending on its therapeutic value and risk profile,” said the official quoted above.

The policy to govern OTC drugs has been in the works for nearly a year now, said industry sources. Several senior executives of pharmaceutical majors as well as the Organisation of Pharmaceutical Producers of India (OPPI) are providing inputs to the government on the matter.

In its paper, “Shaping India’s OTC Policy 2018”, the OPPI said OTC drugs here are a mix of the following — widely available and mass-advertised brands, drugs outside Schedule H but not mass advertised (referred to as deemed OTC), and also drugs in Schedule H but sold without a prescription to patients upon repeat purchase (after an initial prescription by the doctor), and referred to as OTX products. Deemed OTC drugs (such as common calcium supplements) comprise almost 60 per cent of India’s OTC market, estimated to be about ~25,000 crore.