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Health ministry notifies several amendments to D&C Rules, 1945
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Gireesh Babu, New Delhi
February 23 , 2026
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The Union health ministry has notified various amendments to the Drugs and Cosmetics Rules, 1945, comprising inclusion of bacterial endotoxins in the testing requirements, and exclusion of chemical contraceptives such as centchroman and ethinyloestradiol from Schedule H of the Rules.
The notification also mandates inclusion of a condition in certain forms of sales licenses that the sales of drugs shall be made under the personal supervision of a competent person, and any change in the competent person shall be informed to the regulator in a month's time.
These changes are in tune with the recommendations of the Drugs Consultative Committee (DCC) and Drugs Technical Advisory Board (DTAB) after detailed deliberations in their meetings in the past.
The Ministry had issued a draft notification in May, 2025 after consultation with the DTAB and it has been finalised after considering objections and suggestions received from the public, it said.
The notification substitutes the Rule 121A of the Drugs Rules, which so far mandated tests for pyrogens to ensure that parenteral large volumes of 10 ml or above at a time are pyrogen-free. If water or any other aqueous solvent is supplied along with the substances for preparing such solutions, it shall also be pyrogen-free and tested for pyrogens.
The amendment replaces this provision to test for bacterial endotoxins-pyrogens, which stipulates, "Solution of substances intended for parenteral administration (as well as water or any other aqueous solvent supplied along with such substances) shall comply with a test for bacterial endotoxins or, where justified and authorised, with the test for pyrogens and the test for bacterial endotoxins-pyrogens shall be carried out as per current edition of Indian Pharmacopoeia (IP).”
The DTAB, in its 84th meeting in 2019, observed that the existing condition is applicable for products with 10ml volume or more, while there is no such provision mentioned in the Drugs and Cosmetic Act and Rules 1945 for pyrogen testing, for the products with less than 10ml.
This makes it difficult to apply tests for pyrogens as per Rule 121A in products with less than 10ml volume, while as per IP 2018, a test for pyrogens is designated for products irrespective of their volume. The DTAB suggested amendment to the provision to bring alignment in IP and the Rules.
Another amendment notified is for exemption of chemical contraceptives mentioned in Serial No 15 of Schedule K from the provisions of Schedule H. The proposal is to add a sixth foot note to Schedule H, that "Class of drugs mentioned at serial number 15 of Schedule K shall not be covered under this Schedule."
The serial no.15 of Schedule K lists chemical contraceptives having compositions such as DL-0norgestrel 0.30 mg and ethinyoestradiol 0.30 mg, levonorgestrel 0.15 mg and ethinyloestradiol 0.03 mg, centchroman 30 mg, desogestrel 0.150 mg and ethinyloestradiol 0.030 mg, and levonorgestrel 0.1mg and ethinyloestradiol 0.02 mg.
However, the drugs centchrom and ethinyloestradiol are also listed under the Schedule H as entry number 101 and 186, respectively, which has resulted in confusion among the manufacturers and various regulators.
The 91st DTAB meeting held on August 14, 2024, noticed that the finished formulation of these drugs centchroman and ethinyloestradiol attracts the labelling requirement of clause (b) of sub-rule (1) of Rule 97 of Drugs Rules. Accordingly, the label should bear the caution "Not to be sold by retail without the prescription of a Registered Medical Practitioner.”
However, the drugs levonorgestrel-0.15 mg + ethinyloestradiol-0.03 mg and centchroman 30 mg are exempted with regard to provision of sale licence under entry no. 15 of Schedule K, which makes the requirement of prescription by RMP contradictory, it observed.
"Accordingly, it was proposed to make the certain amendments under Drugs Rules, 1945 to avoid contradiction in labelling of products namely levonorgestrel-0.15 mg + ethinyloestradiol-0.03 mg and centchroman-30 mg. DTAB deliberated the matter and agreed for the dose specific amendment in Schedule H under Drugs Rules, 1945," said the Board.
The latest notification also amendments Form 20B, 20G and Form 21B, related to competent person for wholesale of drugs. This mandates a condition that the sale shall be made under personal supervision of a competent person, along with the person's name will be included into these forms. The conditions of license are also amended to mandate that the licensee shall report to the licensing authority in case of any change in competent person within one month of such change.
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