Proposal for simplification of the process for obtaining test licences for import of drugs under Form 11 of the Drugs Rules, 1945, through an acknowledgement based system

REGD. No. D. L.-33004/99 The Gazette of India CG-DL-E-26062026-273857 EXTRAORDINARY PART II-Section 3-Sub-section (i) PUBLISHED BY AUTHORITY No. 458] NEW DELHI, TUESDAY, JUNE 23, 2026/ASHADHA 2, 1948 MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) NOTIFICATION New Delhi, the 23rd June, 2026 G.S.R. 509(E). — The following draft of certain rules further to amend the Drugs Rules, 1945, which the Central Government proposes to make, in exercise of the powers conferred by sub-section (1) of section 12 of the Drugs and Cosmetics Act, 1940 (23 of 1940), after consultation with the Drugs Technical Advisory Board is hereby published for information of all persons likely to be affected thereby, and notice is hereby given that the said draft rules shall be taken into consideration on or after the expiry of a period of thirty days from the date on which the copies of the Gazette of India containing these draft rules are made available to the public. Objections and suggestions which may be received from any person within the period specified above will be considered by the Central Government. Objections and suggestions, if any, may be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, U-6, Work Hall- C Wing, first floor, Kartavya Bhawan-1, New Delhi, 110001 or emailed at [email protected]. DRAFT RULES 1. (i) These rules may be called the Drugs (...... Amendment) Rules, 2026. (ii) These rules shall come into force from the date as specified by the Government at the time of final publication of the rules in the Official Gazette. 2. In the Drugs Rules, 1945 (hereinafter referred to as the said rules), in rule 33, — (i). in clause (a), for the word and number "Form 11", the words, number and brackets "Form 11 or the acknowledgement of prior intimation under the proviso of sub-rule (1) of rule 34 as the case may be" shall be substituted; (ii). In clause (b), — (a) for the word "licensee" the words, number and brackets "licensee or the holder of the acknowledgement of prior intimation under the proviso of sub-rule (1) of rule 34 as the case may be" shall be substituted; (b) for the word "licence" wherever it may occur, the words, numbers and brackets "licence or the acknowledgement of prior intimation under the proviso of sub-rule (1) of rule 34 as the case may be" shall be substituted; (iii). In clause (c), for the word "licensee" the words, number and brackets "licensee or the holder of the acknowledgement of prior intimation under the proviso of sub-rule (1) of rule 34 as the case may be” shall be substituted; (iv). In clause (d), — (a) for the word "licensee" the words, number and brackets "licensee or the holder of the acknowledgement of prior intimation under the proviso of sub-rule (1) of rule 34 as the case may be" shall be substituted; (b) for the word "licence" the words, numbers and brackets "licence or the acknowledgement of prior intimation under the proviso of sub-rule (1) of rule 34 as the case may be" shall be substituted; (v). In clause (e), — (a) for the word "licensee" the words, number and brackets "licensee or the holder of the acknowledgement of prior intimation under the proviso of sub-rule (1) of rule 34 as the case may be" shall be substituted; (b) for the words "holders of licenses" the words, numbers and brackets "holders of licences or the acknowledgements of prior intimation under the proviso of sub-rule (1) of rule 34 as the case may be" shall be substituted; 3. In the said rules, in rule 34, (i). in the marginal heading, for the word "licence", the words "licence or prior intimation" shall be substituted; (ii). After sub-rule (1), the following proviso shall be inserted, — Provided that in case of import of drug for analytical and non-clinical testing (excluding drugs of category of sex hormones, cytotoxic, beta lactam, biologics with live microorganisms and narcotics and psychotropic drugs) an online application in Form 12 to the Central Licencing Authority shall be submitted as prior intimation and the applicant may import such drug based on the acknowledgment of such intimation."; 4. In the said rules, in rule 35, — (i). in the marginal heading, for the word "licence", the words "licence or acknowledgment of prior intimation" shall be substituted; (ii). in sub-rule (1), for the word “licence”, wherever it may occur, the words, numbers and brackets “licence or the acknowledgement of prior intimation under the proviso of sub-rule (1) of rule 34 as the case may be” shall be substituted; (iii). for sub-rule (2), following shall be substituted — A licensee or the holder of the acknowledgement of prior intimation under the proviso of sub-rule (1) of rule 34 as the case may be, whose licence or acknowledgement of prior intimation has been cancelled, may appeal to Central Government within three months of the date of the order. 5. In the said rule, in Schedule A, — (i). In Form 12, — (a) In the heading, for the word "LICENCE", the words "LICENCE OR PRIOR INTIMATION” shall be substituted; (b) In the opening paragraph, for the word “licence”, the words “licence or prior intimation" shall be substituted; [F. No. DC-DT-11011(11)/5/2026-eoffice] HARSH MANGLA, Jt. Secy. Note: The Drugs Rules, 1945 were published in the Official Gazette vide notification No. F. 28-10/45-H(1). dated the 21st December, 1945 and last amended vide notification number G.S.R....dated .... Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064 and Published by the Controller of Publications, Delhi-110054.