The Union health ministry is planning to amend provisions of Schedule V of the Drugs and Cosmetics (D&C) Rules, 1945 to ensure vitamins with doses up to one recommended dietary allowance (RDA) to be regulated under Food Safety and Standards Authority of India (FSSAI) Regulations.
Vitamins with doses up to one RDA
to be regulated under FSSAI
This is following the Drugs Technical Advisory Board (DTAB) having recently examined the Indian Council of Medical Research (ICMR) recommendations. Based on the same, it has been suggested that vitamins with doses of up to one RDA should be regulated under FSS Act.
Other vitamin preparations having prophylactic and therapeutic claims should be regulated under the D&C Act, 1940 and Rules, 1945 including Schedule V of the D&C Rules.
DTAB proposed that necessary review of doses specified under Schedule V may be undertaken subsequently.
Board was apprised that a proposal has been received from Food Safety and Standards Authority of India (FSSAI) proposing that D&C Rules, 1945 may be amended to delete the preparations containing the prophylactic doses under Schedule V considering the provisions of doses under Section 22 of FSS Act, 2006 especially products formulated in tablets, capsules, liquids, etc. meant for oral administration.
As per Section 22 of FSS Act, 2006, it is evident that the products in drug type matrix (i.e. tablets, capsules etc.) covered under FSS Act which are containing vitamins below RDA also fall under prophylactic and some of the therapeutic doses prescribed in Schedule V of the D&C Rules, 1945.
FSSAI has also proposed amending the Schedule K (10) for revising the scope of substances which are used both as articles of food as well as drugs so that same are exempted from the provisions of Chapter IV of the D&C Act and Rules made there under.
Accordingly, DCC in its 52nd Drugs Consultative Committee (DCC) meeting held on September 18, 2017 deliberated the proposal and recommended that a provision may be incorporated in D&C Rules, 1945 especially in Schedule V and Schedule K to exclude multivitamin preparations containing vitamins in a strength which is lower than RDA for Indians as recommended by ICMR and FSSAI, from the provisions of D&C Rules, 1945.
The DTAB further deliberated the matter in its 78th meeting held on February 12, 2018 and opined that the matter may be referred to Director-General (DG), ICMR for their recommendations.
The said matter was then referred to DG, ICMR and a reply in the form of letter dated June 10, 2019 addressed to the DCGI was received along with comments from DG, ICMR. Further, ICMR had made another communication vide letter dated October 14, 2019 to the FSSAI on the same matter.
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