Government forms committee to study drugs marketed in country towards creating OTC category

Mumbai, November 22, 2017:

Based on the deliberations of 52nd meeting of drugs consultative committee (DCC) held recently in Delhi, government formed a sub-committee comprising of five state drug controllers which will soon start examining the drugs marketed in country vis-a-vis conditions for sale stipulated under various schedules like H, H1, G, X, K. The committee will recommend the list of drugs which may be considered for marketing as OTC along with conditions to be followed.

DCC recommended sub-committee comprises of following members- Dr. Ravi Shankar IPS, Drugs Controller, Andhra Pradesh, Drugs controller, Chandigarh, Drugs controller, Uttarakhand, Drugs controller, Karnataka, Joint Director. FDA, Mizoram and Deputy Drug Controller (DDC(I) R. Chandrashekhar as the Convener.

Following the study, an exclusive schedule of over-the-counter (OTC) drugs will be framed in much the similar manner as was done by forming Schedule H1 category in 2014 by bringing habit forming drugs under its ambit. 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.

Medicines to be classified as OTC would be based on the premise that their benefits outweigh their risks, consumer can use them for self-diagnosed conditions, health practitioners are not needed for the safe and effective use of the product containing these actives, the potential for misuse and abuse is low, they can be adequately labeled to enable informed use, acceptable margin of safety based on prior prescription and marketing experience (including OTC experience in other markets).

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.