The Union health ministry will soon amend Schedule K of the Drugs and Cosmetics Rules in respect of the extent of conditions of exemptions in the case of drugs falling under the definition of the term drug but not intended for medicinal use.
The ministry will incorporate a provision under Schedule K in item no. 1, to ensure that the drug substances manufactured for non medicinal use in the country should be with the permission/no objection certificate from the concerned licensing authority. By amending the Schedule K of the Drugs and Cosmetics Rules, the ministry proposes to add the clause: ‘Further, permission from the concerned licensing authority has been obtained for the exemption from the requirements of chapter IV of the Act for manufacture of the product containing the drug substance for non-medicinal use.’
The health ministry's initiative in this connection comes in the backdrop of the fact that many of the products containing drugs are marketed as non-drug items under the exemption provided in Schedule K for drugs not sold for medicinal use or for use in the manufacture of medicines requiring only the container to be labelled with the words “not for medicinal use”. However, the provision is reported to be misused by the manufacturers especially in the case of multivitamin preparations.
There were widespread complaints received in the drug controller general of India (DCGI)'s office that vitamin tablets and capsules are being marketed in the country as dietary/food supplement to circumvent the Drugs Price Control Order (DPCO).
The Drugs Technical Advisory Board (DTAB), the highest authority in the union health ministry on technical matters, had deliberated on the issue in its last meeting held on July 24 this year. After detailed discussion, the DTAB has given its green signal to amend Schedule K of the Drugs and Cosmetics Rules in this regard.
The DTBA also recommended to the Central Drugs Standard Control Organisation (CDSCO) that a sub-committee having representatives of DCG(I), state drugs control authorities and FSSAI may be constituted to prepare a guidance document for licensing vitamin formulations as drugs in the country.