The gazette notification introduces the Drugs (Amendment) Rules, 2023, which amends the Drugs Rules, 1945.
The amendment extends the time period specified in the second proviso of Rule 153 and Rule 153A of the Drugs Rules, 1945.
Key Changes
Rule 153 of the Drugs Rules, 1945 is amended to replace “within eighteen months” with “within twenty four months” in the second proviso.
Rule 153A of the Drugs Rules, 1945 is amended to replace “within eighteen months” with “within twenty four months” in the second proviso.
Impact Analysis
Stakeholders
Consumers: The extension could potentially delay the implementation of certain quality control measures, but it also allows manufacturers more time to ensure compliance, which ultimately benefits consumers.
Suggested Action Items
Legal and regulatory affairs teams should review the updated rules and assess the impact on existing processes and procedures.
Key Entities Referenced
Drugs and Cosmetics Act, 1940: The principal legislation governing the regulation of drugs and cosmetics in India. Section 33N provides the Central Government with the power 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 promotion of Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy systems of medicine.
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
सी.जी.-डी.एल.-अ.-03052023-245635
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CG-DL-E-03052023-245635
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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.