The Drug Technical Advisory Board (‘DTAB’), the highest technical advisory committee under the Drugs and Cosmetics Act, 1940 (‘DCA’), has approved a proposal to amend the item 1 of Schedule K20 of the Drugs and Cosmetics Rules, 1945 (‘DCR’) in such a way that all Persons who manufacture, sale or distribute drugs for non- medicinal use will have to take permissions / no- objection certificate from relevant licensing authority to undertake any of those activities.21 This is similar to an older amendment to Schedule D recommended by DTAB. Under Schedule D, Item 1, an imported drug would be exempted from Part III of the DCA (covering import of drugs), if the label of the drug describes that it is intended to be used for non- medicinal purpose or any purpose other than medicinal purpose. The previous amendment proposed that in addition to the labeling requirement, a no- objection certificate or permission must be taken from the relevant drug authority.
Like Schedule D, Rule 123 of the DCR provides that items specified under Schedule K of the DCR will be exempted from Part IV (Manufacture, Sale and Distribution of Drugs) and Rules thereunder. The item 1 of Schedule K covers ‘drugs not intended for medicinal use.’ Thus, a drug not intended for medicinal use is exempted from application of Part IV of the DCA and supplementary rules in DCR. Many vitamins and multi- vitamins manufacturer had hitherto availed the exemption under Rule 123 by declaring their product as ‘not for medicinal use’ and applied for a license under Food Standards and Safety Act, 2006 (‘FSSA’) to manufacture and market vitamins as a ‘food’.22
This practice, however, is considered illegal as it leads to violation of Drugs Price Control Order, 1995 (‘DPCO’).23 Over the years, the Department of Pharmaceuticals (‘DOP’) has notified many vitamins as controlled drugs. Since the DPCO also applies to formulations prepared form controlled drugs, any vitamin preparation containing controlled vitamins is also brought under price control. This affects products containing multi- vitamins.
In a case where a controlled vitamin or multi- vitamin is registered as ‘food’, it is difficult to enforce the DPCO and control price of the drug. It had been brought to the attention of the DCGI that many vitamin manufacturers were evading price control by registering vitamins as food under the FSSA.24 The proposed amendment sought will fill this regulatory gap by requiring the vitamins manufacturers to register with the Drug Authorities too, making enforcement of DPCO easier.
On a different note, a Scientific Panel on Nutraceuticals has been set up to make recommendations for comprehensive regulations to govern manufacture, sale and distribution of Vitamins and Vitamin Compounds which do not exceed the Recommended Daily Allowance for Indians.