Drugs (Amendment) Rules, 2026 revise endotoxin testing standards, introduce competent person supervision in specified sale licences and clarify Schedule H exclusions

Ministry of Health and Family Welfare has notified the Drugs (Amendment) Rules, 2026 (“Amendment”) which amends the Drugs Rules, 1945 (“Principal Rules”). The Amendment has come into force on 16th February 2026 (i.e., the date of its publication in the Official Gazette). The Amendment Rules introduce changes to pharmacopoeial testing standards for parenteral preparations, impose additional supervisory and reporting obligations in specified sale licences and clarify the scope of drugs covered under Schedule H.

Key Highlights:

1. The existing framework governing testing of solutions intended for parenteral administration has been substituted. Solutions of substances meant for parenteral use, including water or any other aqueous solvent supplied along with such substances, are now required to comply with the test for bacterial endotoxins or, where justified and authorised, with the test for pyrogens. The Amendment further mandates that such testing be conducted in accordance with the current edition of the Indian Pharmacopoeia (I.P.).
2. Form 20B has been amended to expressly require that sale under the licence be carried out under the personal supervision of a competent person, whose name is to be specified in the licence itself. In addition, a new condition has been inserted requiring the licensee to report any change in the competent person to the licensing authority within one month of such change.
3. Similar amendments have been carried out in Form 20G. The sale must be conducted under the personal supervision of a competent person, with the name of such person recorded in the licence. Further, the licensee is required to intimate the licensing authority within one month of any change in the competent person.
4. Form 21B has been amended to insert an additional condition requiring the licensee to report any change in the competent person to the licensing authority within one month of such change. While the core structure of the licence remains otherwise unchanged, the Amendment formalises a specific statutory reporting requirement concerning competent personnel.
5. A new entry has been inserted in the footnote to Schedule H clarifying that the class of drugs mentioned at serial number 15 of Schedule K shall not be covered under Schedule H. This operates as a targeted exclusion and clarifies the regulatory positioning of such drugs vis-à-vis prescription and labelling controls under Schedule H.

Source: E Gazette