With rampant incidents of antimicrobial resistance, substance abuse and drug addiction in the country, the Central Drug Standards Control Organisation (CDSCO) has formed a high level committee of subject matter experts to frame an exclusive schedule of over-the-counter (OTC) drugs in much the similar manner as was done by forming Schedule H1 category in 2014 by bringing habit forming drugs under its ambit.

“The committee of subject matter experts has been recently formed and it would be premature to say how many drugs will come under it and what will be the category name. It will be exclusive of what has been put under Schedule H1 category of habit forming drugs,” says Drug Controller General of India (DCGI) Dr G N Singh.

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.

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.