New Delhi: Through a recent gazette notification, Ministry of Health And Family Welfare has banned the over-the-counter (OTC) sale of 14 steroid-based creams and ointments by finally bringing them under the Schedule H of the Drugs and Cosmetic Rules, 1945. Now, it can be purchased from the chemists only after showing the doctor’s prescription.
Schedule H is a class of prescription drugs in India appearing as an appendix to the Drugs and Cosmetics Rules, 1945 introduced in 1945. These are drugs which cannot be purchased over the counter without the prescription of a qualified doctor.
The Union Ministry of Health has issued a notification as per the notification issued on March 23, 2018, bringing the 14 drugs under the Schedule H of the Drugs and Cosmetic Rules, 1945. These are
- Diflorasone diacetate
- Fluocinolone acetonide
- Halobetasol propionate
- Triamcinolone acetonide.
According to the notification, the decision to put the 14 drugs under Schedule H has been taken after consultation with the Drugs Technical Advisory Board.
The notice states that whereas the draft of certain rules further to amend the Drugs and Cosmetics Rules, 1945 was published as required under sub-section(1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940) in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i) vide notification of the Government of India in the Ministry of Health and Family Welfare, Department of Health and Family Welfare, number G.S.R. 1357(E), dated the 1st November, 2017 inviting objections and suggestions from all persons likely to be affected thereby before the expiry of a period of forty-five days from the date on which copies of the Official Gazette containing the said notification were made available to the public;
The notice further states that the copies of the said Official Gazette were made available to the public on 1st November, 2017 after that objections and suggestions were received from the public on the said rules which had been considered by the Central Government and therefore, in exercise of the powers conferred by section 12 and section 33 of the said Act, the Central Government, after consultation with the Drugs Technical Advisory Board, hereby makes the following rules further to amend the Drugs and Cosmetics Rules, 1945, namely,-
(1) These rules may be called the Drugs and Cosmetics (Second Amendment) Rules, 2018.
(2) They shall come into force on the date of their publication in the Official Gazette.
Below is the attached notification