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 licence 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 labelled with the words 'NOT FOR MEDICINAL USE.'
The DCC, headed by drugs controller general of India (DCGI), Dr G N 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.
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 licence 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 labelled with the words 'NOT FOR MEDICINAL USE.'
The DCC, headed by drugs controller general of India (DCGI), Dr G N 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.
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