The Health Ministry may ask the Drug Technical Advisory Board (DTAB) to examine the issue of banning drug formulations containing diphenoxylate salt and its preparations, following reports of the misuse of this narcotic drug.
Sources said the diphenoxylate, classified as narcotic drug under the Narcotic Drugs and Psychotropic Substances (NDPS) Act, was no longer being used for therapeutic purpose but instead was misused by drug addicts. It can be banned under the Section 26A of the Drugs and Cosmetic Act (D&C) and the DTAB will take up matter.
Diphenoxylate, in combination with atropine, is used as an antidiarrhoeal formulation. However, there is hardly any prescription of diphenoxylate and atropine combination drug and more effective drug loperamide is prescribed by the doctors for this purpose. The drug formulations containing diphenoxylate are widely misused as intoxicants as it contains narcotic drug in the formulation.
“Some addicts take even hundred tablets of this drug at one time and even some drugs manufacturers are packing hundred tablets pouch/bottle packing of this drug though it is a Schedule H drug and can be sold in retail on the prescription of a registered medical practitioner. Previously Dovers Powders IP and Dover Powder tablets IP were banned by the Central Government under Section 26A of the Drugs and Cosmetics Act, 1940 for the similar reasons,” sources said.
The matter was discussed already by the Drugs Consultative Committee which also recommended the banning of this drug as it was commonly misused by the drug addicts. It called for a detailed examination of the matter by the DTAB.
The DCC also took up the case of buprenorpine, a psychotropic substance as per the NDPS Act, but not listed in the Schedule H or X of the D&C Rules, 1945. This drug is also highly misused as intoxicant. Most of the other psychotropic substances are in the list of Schedule H drugs.
The DCC agreed that stricter controls are required for the sale of buprenorpine and recommended that the matter may be examined in detail by the DTAB for its inclusion under Schedule H or Schedule X of the D&C Rules.