Notification/Circular No.: G.S.R. 506(E) dated June 22, 2026
Applicable Act/Rule: Drugs and Cosmetics Act, 1940; Drugs Rules, 1945
Applicable Section/Rule: Section 12 and Section 33
Effective Date: July 1, 2027, except serial number 2 of Table 2 in clause (b) of rule 2, which shall come into force on July 1, 2028
A draft of these rules was published vide notification G.S.R. 757(E) dated October 16, 2025, inviting objections and suggestions from persons likely to be affected, within thirty days from the date copies of the Gazette were made available to the public on October 18, 2025. Objections and suggestions received from the public have been considered by the Central Government. The rules are issued after consultation with the Drugs Technical Advisory Board.
In the Drugs Rules, 1945, in Schedule H2, the existing Table is re-numbered as “Table 1”. After Table 1 as so re-numbered, the following Table 2 is inserted:
Serial Number | Therapeutic Category of drug formulations |
1. | All Vaccines |
2. | All Antimicrobials |
3. | All Narcotic Drugs and Psychotropic Substance, listed under the Narcotic Drugs and Psychotropic Substance Act, 1985 and rules made thereunder |
4. | All Anticancer drugs |
The amendment applies to Schedule H2 of the Drugs Rules, 1945. Entities and persons governed by Schedule H2 are impacted to the extent of the new therapeutic categories listed in Table 2. Serial number 2 (All Antimicrobials) has a deferred effective date of July 1, 2028; all other entries in Table 2 are effective July 1, 2027.
Disclaimer: The information contained in this Article is intended solely for personal non-commercial use of the user who accepts full responsibility of its use. The information in the article is general in nature and should not be considered to be legal, tax, accounting, consulting or any other professional advice. We make no representation or warranty of any kind, express or implied regarding the accuracy, adequacy, reliability or completeness of any information on our page/article.
