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DTAB asks health ministry to scrap draft notification prohibiting ads of Schedule G drugs
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Gireesh Babu, New Delhi
April 10 , 2026
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The Union ministry of health and family welfare may scrap its move to prohibit advertisements of drugs specified in Schedule G - including anti-diabetes formulations having metformin, all types of insulin and various oncology drugs - without the prior approval of the Central government, following a recommendation from the Drugs Technical Advisory Board (DTAB) to shift all drugs mentioned under the Schedule to Schedule H of the Drugs Rules, 1945.
The Board, in its latest meeting held on February 16, agreed with a proposal to withdraw the draft notification the Ministry had issued on July 10, 2024, in the light of the recommendation to shift the drugs to another schedule.
The Board said that it has agreed with the proposal to withdraw the draft notification to prohibit the advertisements of drugs specified in Schedule G, "as once these drugs are shifted to Schedule H, the issue will get addressed automatically".
The recommendation to shift the drugs to Schedule H was made by the Board in its 92nd meeting on April 24, 2025, for better regulatory control.
The draft notification was issued after the recommendation of the DTAB, accepting a proposal from the director of Food and Drugs Administration, Goa.
The draft rules, which shall come into force on the date of their final publication in the Official Gazette, proposes to insert the words Schedule G into the rules 74 (p), 74A (i), 74B (7), 78 (q), and 78A (8), after the words "the drugs specified in".
These rules dealing with conditions of license related to various Forms, at present, specify that no advertisement of the drugs specified in Schedule H, Schedule HI and Schedule X shall be made except with the previous sanction of the Central government.
The Drugs Rules, 1945 already stipulates that the container of medicines which are specified in Schedule G for internal use, shall be labelled with the words "Caution: it is dangerous to take this preparation except under medical supervision," conspicuously printed and surrounded by a line within which there shall be no other words.
Some of the other drugs that are listed in the Schedule G include blood sugar controlling drugs including metformin and its salts, all types of insulin, glibenclamide; chemotherapy and oncology drugs such as aminopterin, L-asparaginase, busulfan and its salts, chlorambucil and its salts, cyclophosphamide and its salts, daunorubicin, hydroxyurea; antibiotic bleomycin; anti epileptic drug methsuximide; anticonvulsant drugs ethosuximide, hydantoin, among others.
It also include several antihistaminic substances, their salts, their derivatives, salts of their derivatives, including antazoline, bromodiphenhydramine, buclizine, chlorcyclizine, chlorpheniramine clemizole, cyproheptadine, diphenhydramine, diphenylpyraline doxylamine, succinate isothipendyl, phenindamine, pheniramine, promethazine, and triprolidine, among others.
The DTAB, in its 81st meeting held on November 29, 2018, picked up the representation from the FDA, Goa, which proposed prohibition of advertisement of drugs specified in Schedule G under the Drugs and Cosmetics Rules.
It said that while the Rule 74 and 78 under the said Rules, states that no advertisement of the Drugs specified in Schedule H, schedule H1 & Schedule X shall be made except with previous sanction of the Central government, but for the drugs specified in Schedule G, there is no provision for prohibition of advertisements which may lead to self-medication.
The FDA proposed an amendment to the conditions of licence for manufacture of drugs prescribed under Drugs & Cosmetics Rules, 1945 to prohibit the advertisement of drugs specified in Schedule G.
The Board deliberated the proposal and agreed to prohibit the advertisements of drugs under the Schedule. It also recommended that the sub-committee constituted for periodic review of Schedule H should also examine the requirement of Schedule G as a separate Schedule and whether the drugs included in Schedule G can be shifted to Schedule H and submit a report for further consideration.
The matter was again taken up in the DTAB meeting held on January 25, 2024 through hybrid mode, and the Board then deliberated the matter. After discussion, the Board agreed for the proposal.
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