**Report on the Drugs Seventh Amendment Rules, 2022**
**1. Executive Summary:**
This report analyzes the Drugs Seventh Amendment Rules, 2022, which amends the Drugs Rules, 1945. The primary purpose of this amendment, based on the provided text, is to streamline the application process for manufacturing new drugs by requiring simultaneous applications for both manufacturing licenses and new drug approvals. The key change involves modifying rule 75 of the Drugs Rules, 1945, to include a new subrule mandating this simultaneous application. This amendment aims to improve the efficiency of the drug approval process.
**2. Introduction:**
This report provides an overview and analysis of the Drugs Seventh Amendment Rules, 2022. The analysis is based solely on the text of the provided official notification. This report is intended to inform affected industries about the specific changes introduced by this amendment.
**3. Policy Overview:**
* **Original Policy:** The Drugs Rules, 1945.
* **Core Objective(s):** The amendment's core objective, as inferred from the text, is to streamline the process for obtaining licenses to manufacture new drugs by synchronizing the application process.
**4. Background and Rationale:**
This amendment appears to address potential inefficiencies in the previous application process, where applications for manufacturing licenses and new drug approvals may have been processed sequentially. This could lead to delays and uncertainty for manufacturers. The amendment aims to resolve this by requiring simultaneous applications, potentially reducing the overall time required to bring new drugs to market. The text suggests a desire for a more coordinated approach.
**5. Key Provisions / Changes:**
This amendment introduces changes specifically to Rule 75 of the Drugs Rules, 1945. The following details the specific changes introduced by the provided amendment text:
* **Specific Part of the Original Policy Being Changed:** Rule 75 of the Drugs Rules, 1945. Also refers to rules 80 and 122B of the New Drugs and Clinical Trials Rules, 2019 and these rules respectively.
* **New Rule/Provision:** A new subrule, designated as 3A, is inserted into Rule 75. This subrule mandates that the application referred to in subrule 3 of rule 75 (application for manufacturing license) and the application for grant of permission to manufacture new drug for sale or distribution under rule 80 of the New Drugs and Clinical Trials Rules, 2019 or rule 122B of these rules, as the case may be, shall be made simultaneously. Subrule 6 is also substituted to state that where an application is for manufacture of drug formulations falling under the purview of new drug, the license to manufacture for sale or distribution of the drugs shall be granted after approval of the drug as new drug.
* **Difference/Effect of the Change:** Previously, the applications could have been made separately. Now, the applications must be submitted at the same time. The effect is a more coordinated and (hopefully) faster review process. Furthermore, the manufacturing license is contingent on the new drug approval.
**6. Target Audience and Stakeholders:**
The target audience primarily includes pharmaceutical manufacturers, particularly those involved in the development and manufacturing of new drugs. This also affects the regulatory bodies responsible for processing drug approvals and manufacturing licenses, and any entity looking to manufacture drug formulations falling under the purview of new drug
**7. Implementation Aspects (Inferred):**
* **Responsible Agency/Bodies:** The Central Government, Ministry of Health and Family Welfare, and the Drugs Technical Advisory Board are mentioned in the text. The Drug Controller is likely the primary implementing body.
* **Timelines/Procedures:** The amendment came into force on the date of its publication in the Official Gazette (August 24, 2022). The text specifies that applications must be made simultaneously. Specific procedures for simultaneous submission will likely be detailed in separate guidelines or circulars.
**8. Expected Outcomes / Impact of Changes:**
The intended outcome of this amendment is to streamline the drug approval process, reducing delays for manufacturers seeking to produce new drugs. The simultaneous application requirement is expected to improve coordination between the licensing and approval processes, potentially leading to faster market access for new drugs.
**9. Conclusion:**
The Drugs Seventh Amendment Rules, 2022, represents a significant step towards improving the efficiency of the drug approval process in India. By mandating simultaneous applications for manufacturing licenses and new drug approvals, the amendment aims to reduce delays and promote faster access to new medicines. This amendment will likely have a positive impact on the pharmaceutical industry and the availability of new drugs to patients.
Key Entities Referenced
Drugs Rules, 1945: A set of rules pertaining to drugs, which is being amended by the current notification.
Drugs and Cosmetics Act, 1940: An act of the Indian parliament related to drugs and cosmetics. Specifically, sections 12 and 33 are referenced as providing the power to make the amendments.
Ministry of Health and Family Welfare: The Indian government ministry responsible for health and family welfare policies. The Department of Health and Family Welfare within the ministry is specifically mentioned.
Central Government: The government of India, which is exercising powers conferred by the Drugs and Cosmetics Act, 1940 to amend the Drugs Rules, 1945.
Drugs Technical Advisory Board: A board consulted by the Central Government before making amendments to the Drugs Rules, 1945.
Drugs Seventh Amendment Rules, 2022: The title of the amendment to the Drugs Rules, 1945, introduced by this notification.
New Drugs and Clinical Trials Rules, 2019: Rules related to new drugs and clinical trials, specifically rule 80 is referenced in the context of applications for manufacturing drugs.
Dr. Mandeep K Bhandari: Jt. Secy., likely a Joint Secretary in the Ministry, signing the notification.
New Delhi, Delhi: The location of the Ministry of Health and Family Welfare, where the notification was issued.
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
सी.जी.-डी.एल.-अ.-24082022-238359
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CG-DL-E-24082022-238359
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ऄसाधारण
EXTRAORDINARY
भाग II—खण् ड 3—ईप-खण्ड (i)
PART II—Section 3—Sub-section (i)
प्राजधकार स ेप्रकाजित
PUBLISHED BY AUTHORITY
स.ं 578] नइ ददल्ली, बुधवार, ऄगस्ट्त 24, 2022/भार 2, 1944
No. 578] NEW DELHI, WEDNESDAY, AUGUST 24, 2022/BHADRA 2, 1944
स्ट्व ास्ट्् य और पररवार कल्य ाण मत्रं ालय
(स्ट्व ास्ट्् य और पररवार कल्य ाण जवभाग)
ऄजधसचू ना
नइ ददल् ली, 24 ऄगस्ट्त, 2022
सा.का.जन. 654(ऄ).—औषजध जनयम, 1945 का और संिोधन करने के जलए कजतपय जनयमों का प्रारूप, औषजध
और प्रसाधन सामग्री ऄजधजनयम, 1940 (1940 का 23) की धारा 12 की ईपधारा (1) और धारा 33 की ईपधारा (1) के
ऄधीन यथा ऄपेजित, भारत सरकार के स्ट् वास्ट् ् य और पररवार कल् याण मंत्रालय (स्ट् वास्ट् ् य और पररवार कल् याण जवभाग) की
ऄजधसूचना स.ं सा.का.जन. 382(ऄ), तारीख 23 मइ, 2022 द्वारा भारत के रािपत्र, ऄसाधारण, भाग II, खंड 3, ईपखंड (i)
म ें प्रकाजित दकया गया था, जिसम ें ईन सभी व् यजययों स,े जिनके ईससे प्रभाजवत होने की संभावना ह ै ईस तारीख स,े जिसको
ईक्त ऄजधसूचना ऄन्तर्ववष्ट करने वाली रािपत्र की प्रजतयां िनता को ईपलब् ध करा दी गइ थीं, तीस ददनों की ऄवजध के
ऄवसान स े पहले अिेप और सझु ाव अंमजत्रत दकए गए थ;े
और, ईय रािपत्र की प्रजतयां 23 मइ, 2022 को िनता को ईपलब् ध करा दी गइ थीं;
और, ईक्त जनयमों पर िनता स ेप्राप्त अिेप और सुझावों पर केन् रीय सरकार द्वारा जवचार कर जलया गया ह;ै
ऄत: ऄब, केन् रीय सरकार, औषजध और प्रसाधन सामग्री ऄजधजनयम, 1940 (1940 का 23) की धारा 12 और
धारा 33 द्वारा प्रदत् त िजययों का प्रयोग करत े हुए, औषजध तकनीकी सलाहकार बोडड स े परामि ड करने के पश् चात,् औषजध
जनयम, 1945 का और संिोधन करन े के जलए जनम्न जलजखत जनयम बनाती ह,ै ऄथाडत:्—
1. (1) आन जनयमों का संजिप्त नाम औषजध (सातवां संिोधन) जनयम, 2022 ह।ै
(2) य े रािपत्र म ेंईनके प्रकािन की तारीख को प्रवृत होंगे।
5727 GI/2022 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
2. औषजध जनयम 1945 के जनयम 75 म,ें —
(क) ईप-जनयम (3) के पश्चात,् जनम्नजलजखत ईप-जनयम ऄंतःस्ट्थाजपत दकया िाएगा, ऄथाडत:् —
“(3क) आन जनयमों के जनयम 75 के ईप-जनयम (3) म ें जनर्ददष्ट अवेदन और नइ औषजध और नैदाजनक परीिण
जनयम, 2019 के जनयम 80 या आन जनयमों के जनयम 122ख, के ऄधीन जबक्री या जवतरण के जलए नइ औषजध
के जवजनमाडण की ऄनुमजत देन े के जलए अवेदन, यथाजस्ट्थजत एक साथ दकया िाएगा ।" ;
(ख) ईप-जनयम (6) के स्ट्थान पर, जनम्नजलजखत ईप-जनयम रखा िाएगा, ऄथातड :् —
“िहां आस जनयम के ऄधीन कोइ अवेदन नइ औषजध और नैदाजनक परीिण जनयम, 2019 के जनयम 80 या
जनयम 122ख के ऄधीन नइ औषजध के दायरे म ें अन े वाली औषजध जवजनर्वमजत के जवजनमाडण के जलए ह,ै
औषजध के जबक्री या जवतरण के जलए जवजनमाडण की ऄनुज्ञजप्त नइ औषजध के रूप म ें औषजध के ऄनुमोदन के
पश्चात ्प्रदान की िाएगी ।” ।
[फा. सं. एक् स. 11014/2/2022–डीअर]
डॉ. मनदीप के भण्डारी, संयुक् त सजचव
रिप्प ण : मूल जनयम, भारत के रािपत्र में ऄजधसूचना संखयांक एफ. 28-10/45-एच (1), तारीख 21 ददसम् बर, 1945
द्वारा प्रकाजित दकए गए थे और ऄजधसूचना संखयांक सा.का.जन. 623(ऄ), तारीख 10 ऄगस्ट्त, 2022 द्वारा ऄंजतम
बार संिोजधत दकए गए थे।
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 24th August, 2022
G.S.R. 654(E).—Whereas a draft of certain rules further to amend the Drugs Rules, 1945, was
published, as required under sub-section (1) of section 12 and 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. 382(E), dated the
23rd May, 2022, 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 thirty 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 said Official Gazette were made available to the public on the
23rd May, 2022;
And whereas, objections and suggestions received from the public on the said rules have been
considered by the Central Government;
Now, therefore, in exercise of the powers conferred by sections 12 and 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 Drugs Rules, 1945, namely:—
1. (1) These rules may be called the Drugs (Seventh Amendment) Rules, 2022.
(2) They shall come into force on the date of their publication in the Official Gazette.
2. In the Drugs Rules 1945, in rule 75,—
“(a) after sub-rule (3), the following sub-rule shall be inserted, namely:―
“(3A) The application referred to in sub-rule (3) of rule 75 of these rules, and the application for
grant of permission to manufacture new drug for sale or distribution under rule 80 of the New
Drugs and Clinical Trials Rules, 2019 or rule 122B of these rules, as the case may be, shall be
made simultaneously.”;[भाग II—खण् ड 3(i)] भारत का रािपत्र : ऄसाधारण 3
(b) for sub-rule (6), the following sub-rule shall be substituted, namely:―
“Where an application under this rule is for the manufacture of drug formulations falling under
the purview of new drug under rule 80 of the New Drugs and Clinical Trials Rules, 2019 or rule
122B, the licence to manufacture for sale or distribution of the drugs shall be granted after
approval of the drug as new drug.”.
[F. No. X.11014/2/2022-DR]
Dr. MANDEEP K BHANDARI, Jt. Secy.
Note : The principal rules were published in the Gazette of India vide notification number F.28-10/45-H(1),
dated the 21st December, 1945 and last amended vide notification number G.S.R. 623(E), dated the
10th August, 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.