The union health ministry will amend item no. 1 of the Schedule K of the Drugs and Cosmetics Rules (D&C Rules) to control marketing of vitamin preparations as food supplements and also to ensure that the drug substances manufactured for non-medicinal use should be with the permission of the concerned licensing authority under the D&C Rules.
The ministry's decision in this regard stems from the fact that a fairly large number of non pharmaceutical units have been manufacturing and selling products containing vitamins in quantities which fall either into prophylactic category or therapeutic category as specified under Schedule ‘V’ of the D&C Rules, 1945 but such products are being indiscriminately licensed under Food Safety and Standards Act, 2006 as dietary supplements/nutritional supplements/nutraceuticals. Many such products carry inserts wherein medicinal claims are also being made.
The issue was discussed by the Drugs Consultative Committee (DCC), which held its 44th meeting on July 20. In the meeting, members raised the issue that many of the vitamin products being manufactured and marketed under license granted under Food Safety and Standards Act, 2006 contain vitamins in quantities much higher than the daily allowable quantities in gross violation of Section 22(1)(a)(ii) of the FSS Act 2006 and are according to Schedule ‘V’ of the Drugs and Cosmetics Rules, 1945.
The item no. 1 of the Schedule ‘K’ of the Drugs and Cosmetics Rules, 1945 provides exemption from all provisions of Chapter IV of the Drugs and Cosmetics Act, 1940 and Rules to the drugs falling under clause [b][i] of section 3 of the Drugs and Cosmetics Act which are not intended for medicinal use and such products are conspicuously labeled with the words ‘NOT FOR MEDICINAL USE’.
The DCC, headed by drugs controller general of India (DCGI), Dr GN Singh, after deliberations agreed for the amendment of item no. 1 of the Schedule ‘K’ of the Drugs and Cosmetics Rules, 1945 to ensure that the drug substances manufactured for non-medicinal use should be with the permission of the concerned licensing authority under the D&C Rules.