This notification, G.S.R. 767(E), dated October 27, 2021, publishes draft rules further amending the New Drugs and Clinical Trials Rules, 2019. The Central Government, in exercise of powers conferred by subsection 1 of section 12 and subsection 1 of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), and in consultation with the Drugs Technical Advisory Board, proposes these amendments. The draft rules will be taken into consideration after forty-five days from the date of availability of this notification to the public. Objections and suggestions are invited and should 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 via email at drugsdivmohfwgov.in.
The proposed amendments, titled the New Drugs and Clinical Trials Rules (Amendment) Rules, 2021, will come into force on the date of their final publication in the Official Gazette. Specifically, the amendment modifies rule 2, sub-rule 1, clause (w), sub-clause (v) of the New Drugs and Clinical Trials Rules, 2019, by substituting "stem cell derived products" with "cell or stem cell derived product". The principal rules were published vide notification number G.S.R. 227(E), dated the 19th March, 2019. The notification is issued under F. No. X. 11014/12/2021-DR.
Key Entities Referenced
New Drugs and Clinical Trials Rules, 2019: A set of rules that the current notification proposes to amend.
Drugs and Cosmetics Act, 1940: The principal act that confers powers to the Central Government to make rules regarding drugs and cosmetics.
Drugs Technical Advisory Board: A board consulted by the Central Government in the exercise of powers conferred by the Drugs and Cosmetics Act, 1940.
Ministry of Health and Family Welfare: The ministry under which the Department of Health and Family Welfare operates; responsible for the notification.
Department of Health and Family Welfare: The department within the Ministry of Health and Family Welfare that issued the notification.
New Delhi: The city where the notification was issued.
Mandeep K. Bhandari: The Joint Secretary who signed the notification.
Nirman Bhavan, New Delhi 110011: Location of Ministry of Health and Family Welfare
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
सी.जी.-डी.एल.-अ.-27102021-230770
xxxGIDHxxx
CG-DL-E-27102021-230770
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.ं 619] नई ददल्ली, बयधवार, अक्त बू र 27, 2021/कार्ततक 5, 1943
No. 619] NEW DELHI, WEDNESDAY, OCTOBER 27, 2021/KARTIKA 5, 1943
स्ट्व ास्ट्् य और पररवार कल्य ाण मत्रं ालय
(स्ट्व ास्ट्् य और पररवार कल्य ाण जवभाग)
अजधसचू ना
नई ददल् ली, 27 अक् तूबर, 2021
सा.का.जन. 767(अ).—नई औषजध और नैदाजनक परीक्षण जनयम, 2019 का संिोधन करने के जलए कजतपय
जनयमों के जनम्नजलजखत प्रारूप, जिसे केन्द्रीय सरकार औषजध तकनीकी सलाहकार बोड ड के परामिड स े औषजध और प्रसाधन
सामग्री अजधजनयम, 1940 (23 के 1940) की धारा 12 की उपधारा (1) और धारा 33 की उपधारा (1) द्वारा प्रदत्त
िजियों का प्रयोग करत े हुए, इसके द्वारा प्रभाजवत होने की संभावना वाले सभी व्यजियों की िानकारी के जलए प्रकाजित
दकया िाता ह ै और एतद्द्वारा सूचना दी िाती ह ै दक उक्त प्रारूप जनयमों पर उस तारीख स े पैंतालीस ददनों की अवजध
समाप् त होने पर या उसके बाद जवचार दकया िाएगा जिस तारीख को इन प्रारूप जनयमों वाले भारत के रािपत्र की प्रजतया ं
िनता को उपलब्ध कराई िाएगी;
केन्द्रीय सरकार द्वारा उपययडि जवजनर्ददष्ट अवजध के भीतर दकसी भी व्यजि स े प्राप्त होने वाली आपजत्तयों और
सयझावों पर जवचार दकया िाएगा;
आपजत्तयां और सयझाव, यदद कोई हों, तो अवर सजचव, (औषजध), स्ट्वास्ट््य और पररवार कल्याण मंत्रालय, भारत
सरकार, कमरा स.ं 434, सी ववग, जनमाडण भवन, नई ददल्ली - 110011 को अग्रेजषत दकया िाए अथवा
drugsdiv-mohfw@gov.in पर ई-मेल की िाए।
प्रारूप जनयम
1. (1) इन जनयमों को नई औषजध और नैदाजनक परीक्षण (….संिोधन) जनयम, 2021 कहा िाएगा।
(2) ये जनयम रािपत्र म ें इनके अंजतम प्रकािन की तारीख को प्रभावी होंगे।
6214 GI/2021 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
2. नई औषजध और नदै ाजनक परीक्षण जनयम, 2019 म,ें जनयम 2 के उप-जनयम (1) म,ें खण्ड (ब) के
उप- खण्ड (v) म,ें “स्ट्टेम सले ” िब्दों के स्ट्थान पर “सेल या स्ट्टेम सेल व्ययत्पन्न उत्पाद” िब्दों को रखा िाएगा ।
[फा. स.ं एक् स.11014/12/2021-डीआर]
डॉ. मनदीप के. भण्डारी, संययक् त सजचव
रटप्पण: मलू जनयम अजधसूचना स.ं सा.का.जन. 227(अ), तारीख: 19 माच,ड 2019 के अधीन सरकारी रािपत्र म ेंप्रकाजित
दकए गए और अंजतम बार अजधसूचना स.ं सा.का.जन.______(अ), तारीख: _____, के अधीन संिोजधत दकए गए।
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 27th October, 2021
G.S.R. 767(E).—The following draft of certain rules further to amend the New Drugs and Clinical
Trials Rules, 2019 which the Central Government proposes to make, in exercise of the powers conferred by
sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of
1940) and in 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 forty-five days from the date on which the copies of
the Gazette of India containing these draft rules are made available to 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 New Drugs and Clinical Trials (......Amendment) Rules, 2021.
(2) They shall come into force on the date of their final publication in the Official Gazette.
2. In the New Drugs and Clinical Trials Rules, 2019, in rule 2, under sub-rule (1), in clause (w), in
sub-clause (v), for the words “stem cell derived products”, the words “cell or stem cell derived product”
shall be substituted.
[F. No. X. 11014/12/2021-DR]
Dr. MANDEEP K. BHANDARI, Jt. Secy.
Note: The principal rules were published in the Gazette of India vide notification number G.S.R. 227(E),
dated the 19th March, 2019 and last amended vide notification number G.S.R. ……(E), 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.