In a first, India to define, regulate over-the-counter drugs- The New Indian Express

Express News Service

NEW DELHI: For the first time, India will have a well-defined list of over-the-counter (OTC ) drugs as the country’ drug regulator has cleared a proposal to lay down specific provisions for the regulation of OTC drugs.

The decision has been taken by the drug consultative committee (DCC) of the Central Drug Standard Control Organization to “promote self-care without compromising patient safety thereby reducing the treatment cost.”

The CDSCO, under the Union Ministry of Health and Family Welfare, has also decided to allow advertisements of medicines that are categorized as OTCs.

The ramifications of the step are expected to be huge for India where most medicines can be bought easily at pharmacies.

The DCC decision comes after recommendations by a subcommittee, which said that there is an urgent need for coming up with a comprehensive OTC drug policy. Unlike countries such as the US, UK and China, India does not have a well-defined legal and policy framework to support and regulate distribution, marketing and consumption of OTC drugs.

India’s drug law does not even mention ‘OTC’ drugs and neither the Drugs & Cosmetics Act, 1940 nor the Drugs & Cosmetics Rules, 1945 define any medicine that can be sold without doctors’ prescriptions.

At its core, the Drugs & Cosmetics Act — this governs all products classified as drugs — is a series of schedules containing specific drugs. Which schedule a drug is listed under decides its regulatory status. Drugs under schedule H, H1 and X cannot be sold without a prescription.

Therefore, from an OTC marketer’s perspective, drugs that fall outside these schedules are considered to be non-prescription and by inference, free to be made available over the counter. However, the law does not explicitly state this. 

The CDSCO has now decided that OTC drugs will be classified into two categories based on the extent of evidence, safety, therapeutic index, need for accessibility to patients, availability, non-habit forming nature, present supply chain mechanism and socioeconomic conditions of the country.

Experts have warned that for formulating such a policy, extreme caution should be exercised.

“There are only five-six evidence-based drugs that can be defined as OTC from the safety point of view and that include paracetamol, laxatives, antacids, local balms and some multi-vitamins,” said Pune-based health activist Anant Phadke.


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