## Policy Analysis Report: New Drugs and Clinical Trials 2nd Amendment Rules, 2022
**1. Executive Summary:**
This report analyzes the New Drugs and Clinical Trials 2nd Amendment Rules, 2022, as published in the Gazette of India on January 18, 2022. This amendment modifies the New Drugs and Clinical Trials Rules, 2019, primarily by introducing the term "Designated Registration Authority" and substituting it for existing terms in specific sections. The core purpose appears to be clarifying the authority responsible for certain regulatory functions related to drug trials and registration. The key finding is that this amendment aims to streamline and clarify the regulatory framework by specifying the designated authority.
**2. Introduction:**
This report aims to provide an informative analysis of the New Drugs and Clinical Trials 2nd Amendment Rules, 2022, based solely on the text published in the Gazette of India, Extraordinary, Part II, Section 3, Subsection i, on January 18, 2022.
**3. Policy Overview:**
* This document is an amendment to the New Drugs and Clinical Trials Rules, 2019.
* Core Objective: Based on the text, the core objective of this *amendment* is to clarify the identity and role of the "Designated Registration Authority" within the existing regulatory framework governing new drugs and clinical trials. This is achieved by formally defining the term and substituting it for other related terms in specific sections.
**4. Background and Rationale:**
This amendment likely addresses a perceived ambiguity or lack of clarity in the original New Drugs and Clinical Trials Rules, 2019. The substitution of "The designated authority" and "Central Licensing Authority" with "The Designated Registration Authority" suggests a need to precisely define and identify the specific entity responsible for the regulatory functions outlined in Form CT-03. This precision likely aims to avoid confusion and ensure accountability in the drug regulation process.
**5. Key Provisions / Changes:**
This amendment introduces the following specific changes:
* **Change 1:** In Rule 2, sub-rule 1, after clause (l), the following clause is inserted: "(la) Designated Registration Authority means the authority designated under subrule 1 of rule 17."
* **Effect:** This formally defines the term "Designated Registration Authority" by referencing sub-rule 1 of rule 17 in the principal rules. This provides a clear legal definition for the term.
* **Change 2:** In the Eighth Schedule, in Form CT-03:
* **(a)(i):** The words "The designated authority" are replaced with "The Designated Registration Authority."
* **Effect:** This substitution directly clarifies that the "Designated Registration Authority," as now formally defined, is the specific authority being referenced in this section of Form CT-03.
* **(a)(ii):** The words, "Regulation of," shall be omitted.
* **Effect:** This removes the words "Regulation of,".
* **(b):** The words "Central Licensing Authority" are replaced with "Designated Registration Authority."
* **Effect:** This substitution clarifies that the "Designated Registration Authority," as now formally defined, is the specific authority being referenced in this section of Form CT-03, instead of the "Central Licensing Authority."
**6. Target Audience and Stakeholders:**
Based on the text, the target audience and stakeholders directly affected by these changes include:
* Pharmaceutical companies and research institutions involved in new drug development and clinical trials.
* Regulatory personnel and staff responsible for administering and enforcing the New Drugs and Clinical Trials Rules.
* The Designated Registration Authority.
**7. Implementation Aspects (Inferred):**
* **Responsible Agency/Bodies:** The "Designated Registration Authority" as defined by referencing sub-rule 1 of rule 17. The Ministry of Health and Family Welfare is the overarching body responsible for the rules. The Drugs Technical Advisory Board was consulted.
* **Timelines/Procedures:** The rules came into force on the date of their publication in the Official Gazette (January 18, 2022). No other specific timelines or procedures are detailed in this amendment text itself.
* The implementation hinges on the accurate identification and application of the term "Designated Registration Authority" in relevant processes and documentation, especially Form CT-03.
**8. Expected Outcomes / Impact of Changes:**
The likely intended outcome of these specific changes is to:
* Reduce ambiguity and confusion regarding the responsible authority for specific regulatory functions related to new drugs and clinical trials.
* Streamline the regulatory process by clearly identifying the "Designated Registration Authority."
* Improve the clarity and enforceability of the New Drugs and Clinical Trials Rules, 2019.
* Ensure a consistent application of the regulations.
**9. Conclusion:**
The New Drugs and Clinical Trials 2nd Amendment Rules, 2022, represent a targeted effort to enhance the clarity and precision of the existing regulatory framework. By defining and substituting terms with "Designated Registration Authority" in specific sections, the amendment aims to streamline processes, reduce ambiguity, and improve accountability within the drug development and clinical trials landscape. This amendment is significant as it contributes to a more efficient and transparent regulatory environment for the pharmaceutical industry.
Key Entities Referenced
NEW DELHI: Location of the notification's publishing.
TUESDAY, JANUARY 18, 2022: Date of the notification.
PAUSHA 28, 1943: Date of the notification according to the Indian national calendar.
MINISTRY OF HEALTH AND FAMILY WELFARE: The ministry responsible for the notification.
Department of Health and Family Welfare: The department within the ministry responsible for the notification.
NOTIFICATION: Type of document.
G.S.R.21E: Notification number.
New Drugs and Clinical Trials Rules, 2019: The rules being amended.
Drugs and Cosmetics Act, 1940: The act under which the rules are being amended.
23 of 1940: Reference to the Drugs and Cosmetics Act, 1940.
Government of India: The government issuing the notification.
G.S.R. 524E: Previous notification number, dated the 2nd August, 2021.
2nd August, 2021: Date of the previous notification (G.S.R. 524E).
Central Government: The governing body responsible for considering suggestions and objections and exercising powers conferred by the act.
Drugs Technical Advisory Board: The board consulted by the Central Government.
New Drugs and Clinical Trials 2nd Amendment Rules, 2022: The title of the amended rules.
Official Gazette: The official publication where the rules are published.
Designated Registration Authority: The authority designated under subrule 1 of rule 17;.
Eighth Schedule: Schedule in the principal rules where Form CT03 is found.
Form CT03: A form within the Eighth Schedule that is subject to changes.
Central Licensing Authority: Authority to be replaced with 'Designated Registration Authority'.
F.No. X.11014132021DR: File number.
DR. MANDEEP K BHANDARI: Jt. Secy.
G.S.R. 227E: The original notification number for the principal rules, dated the 19th March, 2019.
19th March, 2019: Date of the original notification for the principal rules (G.S.R. 227E).
G.S.R. 14E: The last amended notification number, dated the 13th January, 2022.
13th January, 2022: Date of the last amended notification (G.S.R. 14E).
Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi110064: The publishing location.
Controller of Publications, Delhi110054: The publisher.
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
xxxGIDHxxx
सी.जी.-डी.एxलx.x-GअID.-E1x9xx0 12022-232732
CG-DL-E-19012022-232732
ऄसाधारण
EXTRAORDINARY
भाग II—खण् ड 3—ईप-खण्ड (i)
PART II—Section 3—Sub-section (i)
प्राजधकार स ेप्रकाजित
PUBLISHED BY AUTHORITY
स.ं 21 नइ दद्ली, मगं लवार, िनवरी 18, 2022/पौष 28, 1943
No. 21] NEW DELHI, TUESDAY, JANUARY 18, 2022/PAUSHA 28, 1943
स्ट्व ास्ट्् य रर पिरवार क्य ाण मरालं ालय
(स्ट्वास्ट््य रर पिरवार क्य ाण जवभाग)
ऄजधसचू ना
नइ दद्ल ी, 18 िनवरी, 2022
सा.का.जन. 21. (ऄ).—नइ रषजध रर नैदाजनक परीक्षण जनयम, 2019 का अग े रर सिं ोधन करने के जलए
कजतपय जनयमों का प्रारूप, रषजध रर प्रसाधन सामग्री ऄजधजनयम, 1940 (1940 का 23) की धारा 33 की ईपधारा (1)
के साथ पिित धारा 12 की ईपधारा (1) के ऄधीन यथा ऄपेजक्षत, भारत सरकार के स्ट् वास्ट् ् य रर पिरवार क् याण मंरालालय
(स्ट् वास्ट् थ य् रर पिरवार क् याण जवभाग) की ऄजधसूचना सं. सा.का.जन. 524(ऄ), तारीख 2ऄगस्ट्त, 2021 द्वारा भारत के
रािपराल, ऄसाधारण, भाग 2, खंड 3, ईपखंड (i) में प्रकाजित दकया गया था, जिसमें ईन सभी व् यजययों से, जिनके ईससे
प्रभाजवत होने की संभावना ह ै ईस तारीख से, जिसको ईक् त ऄजधसूचना ऄन्तर्ववष्ट करन े वाली रािपराल की प्रजतयां िनता को
ईपलब् ध करा दी गइ थी, पैंतालीस ददनों की ऄवजध के ऄवसान से पहल े अक्षपे रर सुझाव अमं जरालत दकए गए थे;
रर, ईय रािपराल की प्रजतयां 2ऄगस्ट्त, 2021 को िनता को ईपलब् ध करा दी गइ थीं;
रर, ईक्त जनयमों पर िनता स ेप्राप्त अक्षेपों रर सुझावों पर केन् रीय सरकार द्वारा जवचार कर जलया गया ह;ै
368 GI/2022 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
ऄत: ऄब, केन् रीय सरकार, रषजध रर प्रसाधन सामग्री ऄजधजनयम, 1940 (1940 का 23) की धारा 12 रर
धारा 33 द्वारा प्रदत्त िजययों का प्रयोग करते हुए, रषजध तकनीकी सलाहकार बोड ड स े परामिड करने के पश् चात,् नइ
रषजध रर नैदाजनक परीक्षण जनयम, 2019 का संिोधन करन े के जलए जनम्न जलजखत जनयम बनाती ह,ै ऄथाडत्:—
(1) आन जनयमों का संजक्षप्त नाम नइ रषजध रर नैदाजनक परीक्षण (दसू रा संिोधन) जनयम, 2022 ह।ै
(2) य ेरािपराल म ें ईनके प्रकािन की तारीख को प्रवृत होंगे।
2. नइ रषजध रर नैदाजनक परीक्षण जनयम, 2019 (जिस े आसम ें आसके पश्चात् मूल जनयम कहा िाएगा) में,
जनयम 2 के ईपजनयम (1) में, खण्ड (ि) के पश्चात्, जनम्नजलजखत खंड ऄंतःस्ट्थाजपत दकए िाएगं े, ऄथाडत:् —
“(ि क) “जनधाडिरत रजिस्ट्रीकरण प्राजधकारी” स े जनयम 17 के ईपजनयम (1) के ऄधीन पदाजभजहत प्राजधकारी ऄजभप्रेत
ह;ै”
1. मूल जनयम म8ें ,वीं ऄनुसूची के प्ररूप सी.टी.-03 म,ें —
(क) पैरा 1 म,ें —
(i) "जनधाडिरत प्राजधकारी" िब्दों को "जनधाडिरत रजिस्ट्रीकरण प्राजधकारी" िब्दों स े प्रजतस्ट्थाजपत दकया
िाएगा ;
(ii) “के जवजनयमन” िब्दों का लोप दकया िाएगा;
(ख) “नामजनर्ददष्ट प्राजधकरण” िब्दों के स्ट्थान पर “जनधाडिरत रजिस्ट्रीकरण प्राजधकारी” िब्दों को रखा िाएगा।
[फा.सं. एक् स. 11014/13/2021—डीअर]
डॉ. मनदीप के भण्डारी, संयुक् त सजचव
िटप्प ण:- मूल जनयम, भारत के रािपराल म ें ऄजधसूचना संखयांक सा.का.जन. 227(ऄ), तारीख 19 माच,ड 2019 द्वारा
प्रकाजित दकए गए रर ऄंजतम बार ऄजधसूचना स.ं सा.का.जन. 14(ऄ), तारीख 13 िनवरी, 2022 द्वारा संिोजधत
दकए गए।
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 18th January, 2022
G.S.R.21(E).—Whereas a draft of certain rules further to amend the New Drugs and Clinical Trials
Rules, 2019, was published as required by sub-section(1) of section 12 read with sub-section(1) of section
33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), vide notification of the Government of India in the
Ministry of Health and Family Welfare (Department of Health and Family Welfare) number G.S.R. 524(E),
dated the 2nd August, 2021, in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i),
inviting objections and suggestions from persons likely to be affected thereby, before the expiry of a period
of forty-five days from the date on which the copies of the Official Gazette containing the said notification
were made available to the public;
And whereas copies of the Gazette were made available to the public on 2nd August, 2021;
And whereas, objections and suggestions received from the public on the said rules have been
considered by the Central Government;[भाग II—खण् ड 3(i)] भारत का रािपराल : ऄसाधारण 3
Now, therefore, in exercise of the powers conferred by section 12 and section 33 of the Drugs and
Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with the Drugs Technical
Advisory Board, hereby makes the following rules further to amend the New Drugs and Clinical Trials
Rules, 2019, namely:—
1. (1) These rules may be called the New Drugs and Clinical Trials (2nd Amendment) Rules, 2022.
(2) They shall come into force on the date of their publication in the Official Gazette.
2. In the New Drugs and Clinical Trials Rules, 2019 (hereafter referred to as the principal rules), in
rule 2, in sub-rule(1), after clause (l), the following clause shall be inserted, namely:─
“(la) “Designated Registration Authority” means the authority designated under sub-rule (1) of rule
17;”
3. In the principal rules, in Eighth Schedule, in Form CT-03,─
(a) In para1,─
(i) for the words, “The designated authority”, the words “The Designated Registration
Authority” shall be substituted;
(ii) the words, “Regulation of”, shall be omitted;
(b) For the words, “Central Licensing Authority”, the words “Designated Registration
Authority” shall be substituted.
[F.No. X.11014/13/2021-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 No. G.S.R. 14(E), dated the 13th
January, 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.