In order to eradicate the abuse of narcotic drugs in the country, government is planning to amend Rule 97 of the Drugs and Cosmetics Rules, 1945 to introduce a provision of labeling with symbol NRx for drugs falling under the purview of the Narcotic Drugs and Psychotropic Substances Act, 1985 (NDPS Act), 1985 and covered under Schedule H1. The proposal on the same was deliberated at the recent Drug Technical Advisory Board (DTAB) meeting.

Drugs and Cosmetics Rules, 1945 were amended vide Gazette notification dated 30 August, 2013 for introduction of new Schedule H1 containing certain antibiotics, anti-TB drugs and habit forming drugs in pursuance of the recommendations of the Task Force on antimicrobial resistance.

As Schedule H1 also contained certain drugs falling under the purview of the NDPS Act, 1985 which were earlier in Schedule H and were required to be labeled with the symbols NRx which shall be in red and conspicuously displayed on the left corner of the label, it was proposed to have a similar provision under Schedule H1 for the drugs under the purview of the Narcotic Drugs and Psychotropic Substances Act, 1985 as is available for drugs falling under Schedule H.

Maharashtra Food and Drug Administration (FDA) had in the past also recommended the Drugs Controller General of India (DCGI) for inclusion of Codeine, other narcotic drugs and psychotropic substances in Schedule X of the Drugs and Cosmetics Act, 1940. Codeine, other narcotic drugs and psychotropic substances are currently listed under Narcotics and Psychotropic Substances Act 1985.

It is given to understand that though the inclusion of drugs in Schedule H has drastically increased but those included in Schedule X have reduced due to some omissions.

Schedule X 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 drug and cosmetics act contains a list of 536 drugs which are required to be dispensed on the prescriptions of a registered medical practitioner. In order to have separate regulation to check unauthorized sale of antibiotics, a separate schedule as Schedule H1 has also been introduced under the Drugs and Cosmetics Rules to regulate sale of 46 drugs exclusively.

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.

Besides this, taking the present scenario into consideration, 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 there under.

According to a senior FDA official, "Regulations impart a stringent control over products covered under Schedule X with respect to those covered under Schedule H for purchase, stocking, distribution and sale criteria. This directly implies a more rigid accountability in the supply chain of drugs covered under Schedule X with a focus to prevent and control abuse of the products."