Executive Summary:
This notification announces amendments to the Drugs Rules, 1945, as per the Drugs and Cosmetics Act, 1940. These amendments, referred to as the Drugs 5th Amendment Rules, 2021, will come into force on the date of their publication in the Official Gazette. The central government considered public feedback on the draft rules before finalizing them.
Key Points / Main Content:
* **Amendment Overview:**
* The Drugs Rules, 1945 are further amended.
* These rules are called the Drugs 5th Amendment Rules, 2021.
* These rules come into force on the date of their publication in the Official Gazette.
* **Rule 90 Amendment:**
* In subrule 2, the term "Form 29" is replaced with "Form 30".
* **Subrule Insertion:**
* A new subrule is inserted after the amended subrule 2.
* **License Granting:**
* The licensing authority may grant a license in Form 29 within seven working days of receiving a completed application in Form 30.
* If no communication is received within seven days, the license is deemed granted.
Impact Analysis:
* **Licensing Authorities:**
* Impact: Must process Form 29 licenses within seven working days of receiving completed Form 30 applications.
* Action Required: Ensure procedures are in place to meet the seven-day deadline for license approval or communication.
* **Applicants for Drug Licenses:**
* Impact: Can expect quicker license approvals (deemed approval if no communication within seven days).
* Action Required: Submit complete Form 30 applications to facilitate prompt processing and be aware of the deemed approval provision.
* **Central Government:**
* Impact: Responsible for implementing and overseeing the amended Drugs Rules.
* Action Required: Ensure that these amendments are effectively communicated and enforced.
Key Entities Referenced
Drugs Rules, 1945: A set of rules pertaining to drugs, which are being amended by this notification.
Drugs and Cosmetics Act, 1940: An act of the Indian Parliament related to drugs and cosmetics, under which the present notification is issued.
Ministry of Health and Family Welfare: The Indian government ministry responsible for health and family welfare policies and programs.
New Delhi: The location of the Ministry of Health and Family Welfare, where the notification was issued (Union Territory of Delhi).
Drugs Technical Advisory Board: A board that the Central Government consults with when amending the Drugs Rules, 1945.
Drugs 5th Amendment Rules, 2021: The name given to the amendments to the Drugs Rules, 1945, as specified in this notification.
Form 29: A form mentioned in the Drugs Rules, 1945, which is related to licensing.
Form 30: A form mentioned in the Drugs Rules, 1945, which is related to licensing.
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
सी.जी.-डी.एल.-अ.-27102021-230769
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CG-DL-E-27102021-230769
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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.ं 618] नइ ददल्ली, बुधवार, ऄक्त बू र 27, 2021/कार्वतक 5, 1943
No. 618] 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)
ऄजधसचू ना
नइ ददल् ली, 27 ऄक् तूबर, 2021
सा.का.जन. 766(ऄ).—औषजध जनयम, 1945 का और संिोधन करन े के जलए कजतपय जनयमों का प्रारूप, औषजध
और प्रसाधन सामग्री ऄजधजनयम, 1940 (1940 का 23) की धारा 12 की ईप-धारा (1) और धारा 33 की ईप-धारा (1)
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. 533(ऄ), तारीख 3 ऄगस्ट्त, 2021 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 सुझाव अंमजत्रत दकए गए थ;े
और, ईय रािपत्र की प्रजतयां 3 ऄगस्ट्त, 2021 को िनता को ईपलब् ध करा दी गइ थीं;
और, ईक्त जनयमों पर िनता स ेप्राप्त अिेप और सझु ावों 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 करते हुए, औषजध तकनीकी सलाहकार बोडड स े परामिड करन े 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 (पांचवां संिोधन) जनयम, 2021 ह।ै
(2) ये जनयम रािपत्र म ें आनके प्रकािन की तारीख को प्रवृत्त होंगे।
6213 GI/2021 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
(2) औषजध जनयम, 1945 म,ें जनयम 90 म,ें —
(i) ईप-जनयम (2) में, “प्ररूप 29” िब्दों और ऄंकों के स्ट्थान पर, “प्ररूप 30” िब्दों और ऄंकों को रखा िाएगा;
(ii) यथासंिोजधत ईप-जनयम (2) के पश्चात,् जनम्नजलजखत ईप-जनयम को ऄंतःस्ट्थाजपत दकया िाएगा, ऄथातड ्:—
“(3) लाआसेंजसग प्राजधकरण द्वारा प्ररूप 29 म ें लाआसेंस जवजधवत भरे हुए प्ररूप 30 म ें अवदे न की प्राजप्त की
तारीख स े सात काय-ड ददवसों के ऄंदर प्रदान दकया िाए, और ऐसे मामलों म ें िहां अवेदक द्वारा ऐसी
सात काय-ड ददवसों की ऄवजध के ऄंदर लाआसेंजसग प्राजधकरण स े कोइ सूचना प्राप्त नहीं होती ह,ै तो लाआसेंस
लाआसेंजसग प्राजधकरण द्वारा प्रदत्त माना िाएगा ।” ।
[फा. स.ं एक् स. 11014/2/2021-डीअर]
डॉ. मनदीप के. भण्डारी, संयुक् त सजचव
रिप्पण: मलू जनयम ऄजधसुचना स.ं एफ. 28-10/45-एच (1), तारीख 21 ददसम् बर, 1945 के द्वारा रािपत्र म ें प्रकाजित
दकए गए और ऄंजतम बार ऄजधसूचना स.ं सा.का.जन. 716(ऄ), तारीख 1, ऄक्िूबर, 2021 के ऄधीन 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. 766(E).—Whereas a draft of certain rules further to amend the Drugs Rules, 1945,
was published, as required under sub-section (1) of sections 12 and sub-section (1) of 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. 533(E), dated the 3rd 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 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
3rd August, 2021;
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 (5th Amendment) Rules, 2021.
(2) They shall come into force on the date of their publication in the Official Gazette.
2. In the Drugs Rules, 1945, in rule 90,—
(i) in sub-rule(2), for the word and figures “Form 29”, the word and figures “Form 30”
shall be substituted;[भाग II—खण् ड 3(i)] भारत का रािपत्र : ऄसाधारण 3
(ii) after sub-rule(2) as so amended, the following sub-rule shall be inserted, namely:—
“(3) The license in Form 29 may be granted by the licensing authority within a period
of seven working days from the date of receipt of the application duly completed in
Form 30, and in case where no communication is received by the applicant from
licensing authority within the said period of seven days, the licensing authority shall
be deemed to have granted the license.”
[F. No. X. 11014/2/2021-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. 716(E), dated the 1st October, 2021.
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.