India mulls reclassifying vitamins as drugs if they come with health claims

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.”​

Feedback sought​

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.