The gazette notification publishes a draft of rules to further amend the Drugs Rules, 1945. This is done in exercise of the powers conferred by subsection (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940.
The notification invites objections and suggestions from all persons likely to be affected by the draft rules. These objections and suggestions will be considered by the Central Government.
The draft rules will come into force on the date of their final publication in the Official Gazette.
Key Changes
The draft rules propose to amend rule 43A of the Drugs Rules, 1945.
The amendment involves substituting the words “and Krishnapatnam port” with “Krishnapatnam and Gangavaram ports”.
The public has 30 days from the date the gazette is available to submit objections or suggestions.
Impact Analysis
Stakeholders
General public: Indirectly affected through the availability and quality of drugs and cosmetics.
Suggested Action Items
Government Affairs: Engage with the Ministry of Health and Family Welfare to understand the rationale behind the proposed changes and to advocate for the company's interests.
Key Entities Referenced
Drugs and Cosmetics Act, 1940: The principal legislation governing the import, manufacture, distribution, and sale of drugs and cosmetics in India.
Drugs Rules, 1945: Rules framed under the Drugs and Cosmetics Act, 1940, providing detailed regulations for the implementation of the Act.
Ministry of Health and Family Welfare: The government ministry responsible for health policy in India.
Krishnapatnam Port: A port in Andhra Pradesh, India, currently listed in Rule 43A of the Drugs Rules, 1945.
Gangavaram Port: A port in Andhra Pradesh, India, proposed to be added to Rule 43A of the Drugs Rules, 1945.
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
सी.जी.-डी.एल.-अ.-02032023-244033
xxxGIDHxxx
CG-DL-E-02032023-244033
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.ं 122] नई दिल्ली, बुधवार, माच च1, 2023/फाल्ग नु 10, 1944
No. 122] NEW DELHI, WEDNESDAY, MARCH 1, 2023/PHALGUNA 10, 1944
स्ट्व ास्ट्् य और पररवार कल्य ाण मत्रं ालय
(स्ट्वास्ट््य और पररवार कल्याण जवभाग)
अजधसचू ना
नई दिल्ली, 1 माच च 2023
सा.का.जन. 158(अ).—औषध और प्रसाधन सामग्री अजधजनयम, 1940 (1940 का 23) की धारा 12 की उप-धारा
(1) और धारा 33 की उप-धारा (1) द्वारा प्रित्त िजियों का प्रयोग करते हुए केंद्र सरकार जचदकत्सा औषध जनयम, 1945 म ें
और संिोधन करने के जलए जिन कजतपय जनयमों को बनान े का प्रस्ट्ताव करती ह ै उनका जनम्नजलजखत मसौिा इससे प्रभाजवत
होने वाल े संभाजवत सभी व्यजियों के सूचनार् च एतद्द्वारा प्रकाजित दकया िाता ह ै और एतद्द्वारा सूचना िी िाती ह ै दक उि
जनयमों का मसौिा इन मसौिा जनयमों स े युि भारत के रािपत्र की प्रजतयां आम िनता के जलए उपलब्ध कराए िाने की
तारीख स े सात दिनों की अवजध समाप्त होने पर या उसके बाि जवचारार्च जलया िाएगा;
ऊपर जनर्िचष्ट अवजध के भीतर दकसी भी व्यजि स े प्राप्त आपजत्तयों और सुझावों पर केंद्र सरकार द्वारा जवचार दकया
िाएगा;
आपजत्तयां और सुझाव, यदि कोई ह,ैं अवर सजचव (औषध), स्ट्वास्ट््य और पररवार कल्याण मंत्रालय, भारत सरकार,
कमरा स.ं 434, सी-ववंग, जनमाणच भवन, नई दिल्ली-110011 को भेि े िा सकत े ह ैं या drugsdiv-mohfw@gov.in. पर
ई-मेल दकए िा सकत े ह।ैं
मसौिा जनयम
1. (1) इन जनयमों का नाम औषध (.......संिोधन) जनयम, 2022 ह।ै
1365 GI/2023 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
(2) य ेजनयम सरकारी रािपत्र म ें इनके अंजतम रूप स ेप्रकािन की तारीख स े प्रवृत होंगे।
2. औषध जनयम, 1945 के जनयम 43क म ें िब्ि “और कृष्णापत्तनम” िब्िों के स्ट्र्ान पर “कृष्णापत्तनम और
गंगावरम बंिरगाह” िब्ि रख ेिाएंगे।
[फा.स.ं एक्स.11035/131/2022-डीआर]
रािीव वधावन, सलाहकार (लागत)
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 1st March,2023
G.S.R. 158(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 subsection (1) of
section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), 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, Room No. 434,C Wing, Nirman Bhavan, New Delhi -
110011 or emailed at drugsdiv-mohfw@gov.in.
DRAFT RULES
1. (1) These rules may be called the Drugs (... Amendment) Rules, 2022.
(2) They shall come into force on the date of their final publication in the Official Gazette.
2. In the Drugs Rules, 1945, in rule 43A, for the words “and Krishnapatnam port”, the words,
“Krishnapatnam and Gangavaram ports” shall be substituted.
[F.No. X.11035/131/2022-DR]
RAJIV WADHAWAN, Advisor (Cost)
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.