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Efforts to amend Schedule V of D&C Act to seek approval from FSSAI for vitamins need coordination: Experts
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Nandita Vijay, Bengaluru
November 30 , 2020
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Just as the government is preparing to amend provisions of Schedule V of the Drugs and Cosmetics (D&C) Rules, 1945 to ensure vitamins and minerals with doses up to one recommended dietary allowance (RDA) to be regulated under Food Safety and Standards Authority of India (FSSAI) regulations, industry experts are of the view that themove would require coordination and accurate data submission to the new regulatory authority.
For all vitamins listed in Schedule V with doses of up to one RDA should be regulated under FSS Act, notes Drugs Technical Advisory Board (DTAB) after it assessed the Indian Council of Medical Research (ICMR) recommendations. Those 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.
Dr DBA Narayana, who is the face behind the move as the former scientific member of FSSAI and now chairman, scientific panel, nutraceuticals for the Union government, said that it was a step in the right direction. It will bring in the required clarity to both the pharma/food industry and consumer.
“As experts from the FSSAI, we saw that there was a need for clarity for vitamin and mineral preparations. We suggested that a very old notification like Schedule V required to be amended,” Dr Narayana told Pharmabiz.
“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 FSSAI proposing that D&C Rules, 1945 may be amended to delete the preparations containing the prophylactic doses under Schedule V considering the provision of doses under Section 22 of FSS Act, 2006 especially products formulated in tablets, capsules, liquids, etc. meant for oral administration,” stated a recent report in the public domain.
Section 22 of FSS Act, 2006, noted vitamin drugs as tablets, capsules covered under FSS Act below RDA also come 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) to revise the scope of substances used both as food and drugs so that same are exempted from the provisions of Chapter IV of the D&C Act and Rules.
According to Dr Vaibhav Kulkarni, Global ILSI Chair for ILSI Board Assembly & Board Member and Hon. Secretary, Health & Dietary Supplements Association (HADSA), all vitamins and minerals, below therapeutic dosage, covered under Schedule V of the D&C Act may now have to be approved by the FSSAI. This essentially means, pharma companies manufacturing nutraceuticals in various forms like capsules and tablets etc. with no therapeutic dose claim will now have to approach a new regulator, the FSSAI, since the DGCI will no longer license these products.
While, it is premature to tell whether this is a good move unless we have clarity on the details of the draft regulations, pharma companies, who presently had limited interaction with the food regulator, will have to adapt to this new norm. Only time will tell what the advantages and disadvantages are. For successful implementation, close coordination between the industry, DCGI and the food regulator will be required. Also, how they deal with it maturely will determine the future course of action, added Dr Kulkarni.
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TOPICS
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