The Indian Drug Manufacturers Association (IDMA) has urged the Drugs Technical Advisory Board (DTAB) to delete Schedule V of Drug and Cosmetics Act (D&C Act), 1945 or to amend the schedule in such a manner that it does not overlap with Recommended Daily Allowance (RDA) as it would refrain the nutraceutical manufacturers from including vitamins in their health supplements and would also affect the over the counter (OTC) sale of health supplements.
Earlier, the DTAB sub-committee had proposed and it was later accepted by the DTAB in its 68th meeting held on June 12, 2015, that all vitamins incorporated in a product, and having a quantity as mentioned in schedule V (prophylaxis or therapeutic), will imply that the formulation concerned is a drug.
As per the DTAB endorsed recommendations ingredients which are within RDA level, but fall under the range as prescribed under Schedule V of D&C Rules shall be classified as drug.
Sandeep Gupta, vice chairman of IDMA nutraceutical sub-committee says, “The recommendation defies logic since it entails even prophylactic amounts of vitamins will make the product being classified as a drug and cannot be marketed as a health supplement.”
He further adds, “There are many vitamins specified amounts as per RDA which overlap the values mentioned under their prophylactic use as per Sch V in the D&C Rules, 1945. It would be but unimaginable to classify all such products providing vitamins as per RDA and which also qualify for prophylactic use as drugs. This actually nullifies the role and functionality of national bodies such as National Institute of Nutrition (NIN) whose mission is to enable food and nutrition security conducive to good health, growth and development and increase productivity through dedicated research, so as to achieve the national nutrition goals set by the government of India in the national nutrition policy.”
“If the NIN set RDA is not recognised in food items then products such as Complan, Horlicks, etc. which incorporate vitamins (as per RDA) would be classified as drugs and require to be prescribed,” he opined.
Dr R K Sanghavi, chairman of IDMA nutraceutical sub committee says, “A drug definition does not provide for vitamins to be used as medicines necessary to maintain normal well-being in otherwise healthy individuals. Vitamins do fall under the purview of medicines needed for preventing diseases or disorder but not as drugs for maintaining good health. For preventing inadequate vitamin intake all apparently healthy Indians need to take at least the RDA specified to maintain their well – being. It is for the manufacture of drugs and food business operator (FBO) engaged in introducing health supplement products, to decide whether to take a FSSA license or drug license depending on the content/composition, intent and purpose of the product to be introduced as a drug or health supplements.”
He has also suggested that the Schedule V must include all vitamins whose deficiency states are known and their quantities specified for therapeutic use in treating the conditions. Overriding the FSSA wherein RDA is defined and vitamins are mentioned as food by D&C Act defined Schedule V would be unconstitutional and could play havoc with consumer health. It would be prudent to involve the NIN, Indian Council of Medical Research (ICMR) and stakeholders in all deliberations since a panel of self-appointed members in which only one clinician apparently features cannot be permitted to finalise such a sensitive issue with long term repercussions on nation's population well-being.