In order to prevent and minimise the abuse of narcotic drugs in the country, the Indian Drug Manufacturers Association (IDMA) has urged the Union Health Ministry that all prescription medicines covered under Schedule H, H1, G and X be clubbed together and categorised as prescription only medicines and all others be considered as non prescription medicines.

The IDMA has submitted a representation highlighting the need for distinct labelling for various classes of products to clear misconceptions and bring ease of use to the industry, medical professionals, distributors, retailers, patients and the regulatory officials.

In its representation, IDMA said that various schedules such as Schedule H, H1, G and X for the prescription products with various labeling requirements applicable to each category were added over the years to the Drugs and Cosmetics Rules and these instructions, red lines, box warnings etc were confusing and at times led to wrong interpretations.

All narcotic drug and psychotropic substances (NDPS) products were not narcotics and thus abused, as the NDPS Act also covered psychotropic drugs which were habit forming and controlled substances, which were basically precursors.

The Union health ministry had also published a draft notification dated August 12, 2016 proposing to amend labelling provisions under rules 96 and 97 of Drugs and Cosmetics Rules.

For easy and better distinction, the packs of these sub-categories could be color coded with an abbreviated mark POM to indicate that it is a prescription only medicine on the label. Further suffix 123 etc to indicate different types of compliance could be added.

State drug controllers have also recommended to the Drugs Controller General of India (DCGI) in the past 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 has been observed that though the inclusion of drugs in Schedule H has drastically increased, those included in Schedule X have reduced due to some omissions. Says an FDA official, "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 Drugs 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 thereunder.

Experts say 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.