State FDA seeks inclusion of narcotic drugs under Sch X of D&C Act for better regulation

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In order to eradicate and minimise the abuse of Narcotic Drugs in the state, Maharashtra Food and Drug Administration (FDA) has 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.

FDA has observed that that though the inclusion of  drugs in Schedule H has drastically increased whereas 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 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 thereunder.

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.”

Due to the vast growth in the number of chemists and druggists in the country, the drug regulatory mechanism in the country as a whole has an uphill task for proper regulatory enforcement considering the fact that abuse of drugs covered under Narcotic Drugs and Psychotropic Substances Act, 1985 is on the rise due to various socio-economic factors.

Pinpointing on the rampant misuse of Narcotic and Psychotropic substances, a senior FDA official says, “Since these products are covered under Schedule H of the Drugs and Cosmetics Act 1940 and Rules thereunder, except the 15 covered under Schedule X, the effective monitoring of these products is tedious and time consuming. This has led to more manufacturers marketing their products containing Narcotic Drugs and Psychotropic substances resulting in more availability of the products and hence of more misuse and abuse.”

The regulations of Narcotics drugs are more severe than that for Psychotropic substances under the Narcotics and Psychotropic substances Act. The Central Government vide notification no. S.O. 826 (E) dated 14.11.1985 has declared the list of Narcotic drugs and preparations to be considered to be manufactured drugs. At Sr. No. 35 Codeine is stated. This entry has exemption for preparations compounded with one or more other ingredients and containing not more than 100 mg of the drug per dosage unit and with a concentration of not more than 2.5 per cent in undivided preparation and which has been established in therapeutic practice are not to be considered as manufactured narcotic drug.

Hence, these preparations are also as per rule 97 (c) not to be labeled with suffix NRx (Narcotic Drugs) but rather to be labeled as Rx (Schedule H) as per rule 96 (b) of Drugs and Cosmetics Act, 1940 and rules thereunder.

Source: Pharmabiz

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