The Ministry of Health and Family Welfare has published draft rules to further amend the Drugs Rules, 1945. These proposed changes, made after consultation with the Drugs Technical Advisory Board, aim to update regulations concerning the testing of parenteral solutions, the supervision of drug sales, and conditions for drug licenses.
The draft of the Drugs (Second Amendment) Rules, 2025, was made public on May 28, 2025, through a gazette notification. The Ministry has invited objections and suggestions from all persons likely to be affected by these amendments, giving a period of thirty days from the date the gazette copies are available to the public for feedback.
Objections and suggestions can be sent to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, Room No. 545, A Wing, Nirman Bhavan, New Delhi – 110011, or via email at drugsdiv-mohfw@gov.in.
Key Proposed Amendments
The draft rules propose the following significant changes to the Drugs Rules, 1945:
Rule 121A: Test for Bacterial Endotoxins-Pyrogens: The existing rule 121A will be substituted to mandate that solutions intended for parenteral administration, as well as any accompanying aqueous solvents, must comply with a test for bacterial endotoxins. The option to use a pyrogens test will only be allowed if justified and authorized. The testing procedure will be as per the current edition of the Indian Pharmacopeia (I.P.). This change emphasizes a more specific and potentially sensitive test for the safety of injectable drugs.
Form 20B (Licence to sell, stock, exhibit or offer for sale or distribute drugs by retail)
- A new paragraph 3 will be inserted, requiring that “The sale shall be made under the personal supervision of a competent person,” with a space to mention the name of the competent person. This aims to ensure responsible dispensing of drugs at retail level.
- Under the ‘Conditions of Licence’, a new condition 2A will be added, stating, “The licensee shall report to the licensing authority any change in competent person within one month of such change.” This seeks to maintain an updated record of qualified personnel involved in drug sales.
- The proviso under condition 3(ii)(c), which exempted manufacturers of beverages, confectionary biscuits, and other non-medicinal products from certain licensing conditions when purchasing drugs for processing, will be deleted. A new second proviso will be inserted, clarifying that these conditions will still not apply to the sale of any drug except antimicrobial drugs to such manufacturers. This suggests a stricter control over the sale of antimicrobial drugs even for non-medicinal product processing.
Forms 20-B and Form 20-BB (Conditions of License): Similar to Form 20B, the proviso under condition 3(ii)(c) in these forms will be deleted, and a new second proviso will be inserted, exempting the sale of all drugs except antimicrobial drugs to manufacturers of beverages, confectionary biscuits, and other non-medicinal products from certain conditions.
Forms 21-B and Form 21-BB (Conditions of License): The proviso under condition 4(ii)(c), which provided a similar exemption for manufacturers of hydrogenated vegetable oils in addition to beverages and confectionary, will be deleted. A new second proviso will be inserted, maintaining the exemption for the sale of all drugs except antimicrobial drugs to these manufacturers.
Form 20G (Licence to sell, stock, exhibit or offer for sale or distribute drugs by wholesale or distribute by retail in more than one shop):
- A new paragraph 3A will be inserted, similar to Form 20B, requiring that “The sale shall be made under the personal supervision of a competent person,” with a space for the name.
- Under the ‘Conditions of Licence’, a new condition 2A will be added, mirroring Form 20B, requiring the licensee to report any change in competent person within one month.
Form 21B (Licence to manufacture for sale or for distribution of drugs excluding those specified in Schedule C and C(1) and X): Under the ‘Conditions of Licence’, a new condition 1A will be inserted, requiring the licensee to report any change in competent person within one month.
Schedule H (List of substances to be sold by retail on the prescription of a Registered Medical Practitioner only): A new entry number 6 will be added to the footnote, stating, “Class of drugs mentioned at serial no. 15 of Schedule K shall not be covered under this Schedule.” This indicates a specific exclusion for a certain class of drugs listed in Schedule K from the prescription-only requirement of Schedule H.
These proposed amendments indicate a focus on enhancing the quality control of parenteral drugs, ensuring responsible dispensing through competent personnel, and refining the conditions under which certain industries can procure drugs, with a particular emphasis on stricter control over antimicrobial drugs.
