The union health ministry will amend Rule 65(9) (b) of the Drugs and Cosmetics Rules, 1945 to better regulate the wholesale of drugs containing dextroproposyphene salts in capsules and tablets, codeine salts in cough syrups and tablets and drugs containing diphenoxylate salt in tablet, which are misused as intoxicants and other potent drugs.

The issue was discussed by the Drugs Consultative Committee (DCC), which held its 44 th meeting on July 20. The DCC, headed by drugs controller general of India (DCGI), Dr GN Singh, after deliberations agreed for the amendment of rule 65(9) (b) so that the drugs are supplied to the drug licensees also by the wholesalers against the written orders.

In the DCC meeting, members raised the issue of narcotic drugs formulations like drugs containing dextroproposyphene salts in capsules and tablets, codeine salts in cough syrups / tablets, diphenoxylate salt in tablets, etc. being widely misused as intoxicants in many states in the country.

All these three salts are narcotic drugs under the NDPS Act 1985 but their drugs formulations coming in the market are not covered in the definition of narcotic drugs as the contents of these salts per dose are less than limits as mentioned at para 35, 58 and 87 in notification No. S.O 826(E) dated 14.11.1985 issued under sub clause (b) of Clause (xi) of section 2 of the NDPS Act, 1985 by central government.

The drug addicts take larger doses of these drugs for intoxication purpose. Similarly, drugs formulations containing many psychotropic substances are also misused for intoxication. Similarly, many other potent drugs e.g. anabolic steroids, sex hormones, sildenafil etc. are misused without prescription of doctors.

As per Drugs and Cosmetics Rules, 1945, these drugs are schedule H drugs and can be sold on prescription. The prescription sale of many of these drugs is very less than actual volume of sales. The drugs are sold by the drugs manufacturers to the distributors and wholesalers in large quantities, who further sell to wholesalers and retailers. As per Rule 65(9) (b) of the Drugs and Cosmetics Rules, 1945 for selling such drugs to doctors and nursing homes etc. written order is required from concerned doctors.

The written orders of drugs licensee whether retailer or wholesalers, is not required for conducting sale of these drugs to drugs licensee. It has been observed that large qualities of these drugs are shown as sold by the wholesalers to the other wholesalers or retailer.

For example, bills are issued in the name of some drugs licensee firm but the supplies are done to some other persons as no signed written order is required to issue bills to drugs licensee. These drugs formulations which are sold on fictitious bills is main cause of availability of such drugs / medicines in the market who even are sold to unlicensed persons. Many cases are detected where wholesalers in their sale records show sales to the other drugs licencee, but when those drugs licencee are asked to show the further sale records of these drugs, they deny the purchase of the drugs. These drugs available freely from many wholesalers without any restrictions. Easy availability of all types of drugs in wholesales is main cause of misuse of drugs.

Rule 65(9) (b) is being amended to control the illegal and unethical sale of these drugs.