Ministry of Health and Family Welfare Proposes some amendments in Drugs Rules
MoHFW, after consultation with the DTAB, has issued draft rules vide notification GSR 345 (E) dated 28.05.2025 and proposes amendment to Drugs Rules, 1945 as under;
- Rule 121A is to be substituted to include test for bacterial endotoxin instead of pyrogen test. Pyrogen test to be allowed only in cases where justified and authorized, so as to reduce the use of animals in testing. Test is extended to all parenteral preparations instead of earlier requirement was for parenteral preparations of volumes 10ml or more at a time.
- The conditions of Licences for Sale of drugs by way of wholesale in Forms 20B, 20BB, 21B, 21BB and 20G are set to change, to require Licensees -
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- Sale shall be effected under the personal supervision of a competent person.
- Any change in competent person to be reported to Licensing Authority within one month of such change.
- Can sale any drug, except antimicrobials, to the unlicensed entity for manufacture of non-medicinal products.
- As per Schedule K, sale of certain chemical contraceptives does not require sale licence, however, the said drugs are included under Schedule H and hence, requires prescription of registered medical practitioner for its sale. This anomaly is now set to go by providing exemption by way of note to Schedule H.
Stakeholders can submit their objections and suggestions 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 emailed at drugsdiv-mohfw@gov.in within the period of 30 days from the date of publication i.e. up to 27.06.2025.