Exclusive category of OTC drugs soon, state drug controllers to be consulted

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Following the recent Drug Consultative Meet in New Delhi, which approved a special provision to include OTC medicines in the Drugs & Cosmetics Rules will further be taken up as the Central Drug Standards Control Organisation (CDSCO) will consult state drug controllers alongwith experts to come out with an exclusive schedule of over-the-counter (OTC) drugs.

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. As per D&C Act 1940 and thereunder Rules 1945, these drugs should be sold against prescription only.

“The new OTC category will be created in much the similar manner as Schedule H1 was created three years ago which included habit forming drugs to be regulated in a proper manner. The state drug controllers will have a crucial role in framing the new category of drugs,” says Drug Controller General of India (DCGI) Dr G N Singh.

The committee of subject matter experts has also been recently formed and the new OTC drug category will be exclusive of what has been put under Schedule H1 category of habit forming drugs, Dr Singh adds.

In order to have separate regulation to check unauthorised sale of antibiotics, a separate schedule as Schedule H1 was introduced in 2014 under the Drugs and Cosmetics Rules to regulate sale of 46 drugs exclusively.

New category of over the counter (OTC) medicines may include anti-allergies, antipyretic (for fever), antiemetic (for vomiting and nausea), muscle relaxants, decongestants (for cough and cold), anti-inflammatory drugs, antacids, external preparations for skin and hormonal contraceptives.

According to sources, 25 per cent of antibiotics, sedatives and pain-killer drugs are today over-prescribed by doctors and are purchased in bulk for drug addiction and substance abuse.

The 46 drugs under Schedule H1 are sold under more than 3,300 brand names and are available in over 20,000 different combinations. It has been observed that there is a rapid rise in the research and development activities resulting in the emergence of more new drugs and formulations. This has resulted in categorising these drugs in various schedules of Drugs and Cosmetics Act 1940 and the Rules thereunder.

Besides this, as per new government notifications, the inclusion of drugs in Schedule H has drastically increased whereas those included in Schedule X have reduced due to some omissions.

DCGI has also been recommended in the past for inclusion of Codeine, other narcotic drugs and psychotropic substances in Schedule X of the Drugs and Cosmetics Act, 1940 for effective regulation. Codeine, other narcotic drugs and psychotropic substances are currently listed under Narcotics and Psychotropic Substances Act 1985.

According to regulatory experts, Schedule X or narcotics drug category comprises of 15 drugs currently as compared to 17 earlier. Meprobamate, methylphenidate and amphetamine are some of the drugs which can be misused. Schedule H of the Drugs and Cosmetics Act contains a list of 536 drugs which are required to be dispensed on the prescriptions of a registered medical practitioner.

Drugs covered under narcotic drugs in Narcotic Drug and Psychotropic Substances Act, 1985 are also included in Schedule H of the Drugs and Cosmetics Act like alprazolam, chlordiazepoxide and clobazam which are habit forming drugs.

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