The multivitamins and supplements are on the rise in terms of disposal in the Indian market. The market is flooded with brands like Revital or supplements like Ferradol. Such multivitamins’ category of drug or just food, in the absence of a clear proliferation of products, has not been decided yet.
The government seems to arrive at an answer soon by changing the regulatory framework. The 1RDA formula in defining the category will serve as the mainstay of the division. The Recommended Dietary Allowance (1RDA) is the level of nutrients required and to be consumed every day to meet all the requirements of a healthy individual.
The category of food or drug can be estimated on the ground that If the ingredients of a particular product are below then the determined as the daily dosage or 1RDA (Recommended Dietary Allowance), it will be deemed ‘food’ and will be regulated by the Food Safety and Standards Act (FSSA), on the other hand, ingredients crossing that defined limit will be a ‘drug’ and regulated under the Drugs and Cosmetics (D&C) Act.
The Drug Controller General of India (DCGI) and the FSSAI held a meeting recently in the direction. Both agencies decided that multivitamin preparations containing vitamins lower than 1RDA would be excluded from the D&C Act. The act will be amended to remove vitamins and minerals below 1RDA for prophylactic purpose from Schedule V. FSSAI asked DCGI to make the necessary amendments in the D&C Act.
To avoid the strict compliances of D&C Act, most of the companies prefer to position their products as health supplements under the FSSA.
Abbott’s FSSAI approved health supplement product Limcee Plus costs Rs 60 for a strip of 15 tablets. On the other hand, chewable vitamin tablet Limcee of the same company which is in the national list of essential medicines since 2013 costs Rs 14 for a strip of 15 tablets.