The proposal was put forward by the Central Drugs Standard Control Organization (CDSCO) this week and is based on the recommendations of its Drugs Technical Advisory Board (DTAB).
The board – which included regulators and industry representatives – said vitamins should be reclassified “if there is a claim for treatment, mitigation or prevention of any diseases or disorder.”
They also concluded that supplements containing vitamins already found in schedule V products should be labelled as drugs even if the ingredient is below recommended daily allowance (RDA) limits.
The committee also made clear that: "Fortified powders which are supposedly exempted under schedule K [of the Drugs and Cosmetics Rules 1945] and for Special Medicinal products (SMP) to be used as substitute for food shall not be considered as food if the label of the product indicates name of disease.”
The board considered various vitamins straddling the boundary between clinically-proven, efficacious drugs and supplement products that manufacturers claim can treat disease.
For example, the committee advised that Pfizer’s Ferradol – a multivitamin marketed as a nutritional supplement – should be reclassified as a drug because it contains ingredients covered by schedule V of the Drugs and Cosmetics Rules 1945.
They reached the same conclusion about Ranbaxy’s Revital, which is a multivitamin supplement for people with “hectic lifestyles and conditions that leave one drained physically and or mentally.”
The Drugs Controller General of India, Dr GN Singh, has requested industry feedback on the proposed reclassification.