The gazette notification introduces the Drugs (Amendment) Rules, 2023, which amends the Drugs Rules, 1945. The amendment extends the timeline for compliance mentioned in Rule 153 and Rule 153A.
Key Changes
Rule 153 of the Drugs Rules, 1945 is amended to replace the phrase 'within eighteen months' with 'within twenty-four months' in the second proviso.
Rule 153A of the Drugs Rules, 1945 is amended to replace the phrase 'within eighteen months' with 'within twenty-four months' in the second proviso.
The Drugs (Amendment) Rules, 2023, come into effect on the date of their publication in the Official Gazette, which is May 3, 2023.
Impact Analysis
Manufacturers/License Holders
Action Item: Review current compliance timelines for Rules 153 and 153A and adjust project plans to align with the extended twenty-four-month period. Communicate the revised timelines to relevant teams and stakeholders.
Regulatory Bodies (Ministry of Ayush/Central Government)
Action Item: Update internal guidelines and procedures to reflect the amended timelines. Communicate the changes to relevant enforcement teams and ensure consistent application of the revised rules.
Consumers
Action Item: No immediate action required, but continue to monitor the quality and safety of drugs available in the market.
Key Entities Referenced
Drugs and Cosmetics Act, 1940: The principal legislation governing the regulation of drugs and cosmetics in India. Section 33N empowers the Central Government to make rules to amend the Drugs Rules, 1945.
Drugs Rules, 1945: The rules framed under the Drugs and Cosmetics Act, 1940, which provide detailed regulations for the manufacture, sale, distribution, and import of drugs and cosmetics.
Ministry of Ayush: The Ministry responsible for the development and propagation of Ayush systems of medicine, including Ayurveda, Yoga & Naturopathy, Unani, Siddha, and Homoeopathy. The notification is issued by the Ministry of Ayush.
Central Government: The governing body that exercises the powers conferred by the Drugs and Cosmetics Act, 1940 to amend the Drugs Rules, 1945.
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
सी.जी.-डी.एल.-अ.-03052023-245635
xxxGIDHxxx
CG-DL-E-03052023-245635
xxxGIDExxx
असाधारण
EXTRAORDINARY
भाग II—खण् ड 3—उप-खण्ड (i)
PART II—Section 3—Sub-section (i)
प्राजधकार स ेप्रकाजित
PUBLISHED BY AUTHORITY
स.ं 271] नई दिल्ली, बुधवार, मई 3, 2023/विै ाख 13, 1945
No. 271] NEW DELHI, WEDNESDAY, MAY 3, 2023/VAISAKHA 13, 1945
आयषु मत्रं ालय
अजधसचू ना
नई दिल्ली, 24 अप्रैल, 2023
सा.का.जन. 341(अ).—औषजध एव ंप्रसाधन सामग्री अजधजनयम, 1940 (1940 का 23) की धारा 33-ढ की उपधारा (1) के
परंतुक द्वारा प्रित्त िजियों का प्रयोग करते हुए, केन्द्र सरकार औषजध जनयमावली, 1945 में और संिोधन करने के जलए जनम्नजलजखत
जनयम बनाती ह,ै अर्ाात,—
1. सजं िप्त नाम और प्रारंभ: (1) इन जनयमों को औषजध (संिोधन) जनयम, 2023 कहा िा सकेगा।
(2) ये रािपत्र में उनके प्रकािन की तारीख को प्रवृत्त होंगे।
2. औषजध जनयमावली,1945 म,ें-
(क) जनयम 153 में, िसू रे परंतुक में, "अठारह माह के भीतर" िब्िों के जलए, "चौबीस माह के भीतर" िब्िों को प्रजतस्ट्र्ाजपत
दकया िाएगा;
(ख) जनयम 153-क में, िसू रे परंतुक में, "अठारह माह के भीतर" िब्िों के जलए, "चौबीस माह के भीतर" िब्िों को प्रजतस्ट्र्ाजपत
दकया िाएगा।
[फा. स.ं टी-11011/7/2021-डीसीसी (आयुष)]
कजवता गग,ा संयक्ु त सजचव
2930 GI/2023 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
टटप्पणी: मूल जनयम 21 दिसंबर, 1945 की अजधसूचना सख्ं या फा. 28-10/45-एच (1) द्वारा भारत के रािपत्र म ें
प्रकाजित दकए गए र् े और 17 नवंबर, 2022 की अजधसूचना संख्या िी.एस.आर. 823 (स्ट्र्ा.) द्वारा अंजतम बार
संिोजधत दकए गए र्े।
MINISTRY OF AYUSH
NOTIFICATION
New Delhi, the 24th April, 2023
G.S.R. 341(E).__ In exercise of the powers conferred by proviso of sub-section (1) of section 33N of the
Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby makes the following rules further to
amend the Drugs Rules, 1945, namely,—
1. Short title and commencement.— (1) These rules may be called the Drugs (Amendment) Rules, 2023.
(2) They shall come into force on the date of their publication in the Official Gazette.
2. In the Drugs Rules, 1945, -
(a) in rule 153, in the second proviso, for the words “within eighteen months”, the words “within twenty
four months” shall be substituted;
(b) in rule 153A, in the second proviso, for the words “within eighteen months”, the words “within twenty
four months” shall be substituted.
[F. No. T-11011/7/2021-DCC (AYUSH)]
KAVITA GARG, Jt. Secy.
Note: The principal rules were published in the Gazette of India, vide, notification No. F. 28-10/45-H(1), dated the
21st December, 1945 and last amended, vide, notification number G.S.R. 823 (E), dated the 17th November,
2022.
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.