Executive Summary:
This notification from the Ministry of Health and Family Welfare publishes draft rules to further amend the Drugs and Cosmetics Rules, 1945. The amendments address the labeling of vaccine preparations and the definition of new drugs. The draft rules were published on July 14, 2014, and were open for public comment for forty-five days from the date the copies of the Gazette of India containing these draft rules were made available to the public.
Key Points / Main Content:
Amendments to Drugs and Cosmetics Rules, 1945:
* These rules may be called the Drugs and Cosmetics 8th Amendment Rules, 2014.
Vaccine Labeling:
* Every vaccine preparation label must include the new drug permission number granted by the licensing authority as defined in clause b of rule 21.
Definition of New Drugs:
* The following shall be deemed to be new drugs unless certified otherwise by the licensing authority as defined in clause b of rule 21:
* All vaccines
* Recombinant DNA (rDNA) derived drugs
* All New Drug Delivery Systems, including modified release dosage forms of a drug formulation
Impact Analysis:
Manufacturers of Vaccine Preparations:
* Impact: Must include the new drug permission number on vaccine labels.
* Action Required: Update vaccine labels to comply with the new labeling requirement.
Manufacturers of rDNA-derived drugs and New Drug Delivery Systems:
* Impact: Affected by the revised definition of "new drugs."
* Action Required: Ensure compliance with requirements for new drugs or obtain certification from the licensing authority if their products are not considered new drugs.
Licensing Authorities:
* Impact: Responsible for enforcing the new rules and providing certifications.
* Action Required: Implement the new rules and process applications for certification of drugs not considered new.
General Public:
* Impact: Affected by changes in drug regulation.
* Action Required: N/A
Key Entities Referenced
Drugs and Cosmetics Rules, 1945: A set of rules in India governing the import, manufacture, distribution, and sale of drugs and cosmetics. This notification proposes amendments to these rules.
Drugs and Cosmetics Act, 1940: An act of the Parliament of India that regulates the import, manufacture and distribution of drugs and cosmetics.
Drugs Technical Advisory Board: An advisory board that provides technical advice to the Central Government of India on matters related to drugs and cosmetics.
Ministry of Health and Family Welfare: A ministry of the Government of India responsible for health policy in India.
Nirman Bhawan, New Delhi 110011: Location of the Ministry of Health and Family Welfare, Government of India.
Drugs and Cosmetics 8th Amendment Rules, 2014: The name proposed for the amendments to the Drugs and Cosmetics Rules, 1945, as outlined in the notification.
Gazette of India: A public journal and an official record of the Government of India.
New Delhi: The capital of India, where the notification was issued.
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[फा.स.ं एBस-11014/1/2014-डीएफBयसू ी ]
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MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 14th July, 2014
G.S.R. 502(E).— The following draft rules further to amend the Drugs and Cosmetics Rules, 1945, which the
Central Government proposes to make, in exercise of the powers conferred by section 12 and section 33 of the Drugs and
Cosmetics Act, 1940 (23 of 1940), after consultation with the Drugs Technical Advisory Board, is hereby published for the
information of all persons likely to be affected thereby, and the 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 the public;
The objections and suggestions which may be received from any person with respect to the said draft rules within
the period specified above, will be considered by the Central Government;
Objections and suggestions, if any, may be addressed to the Secretary, Ministry of Health and Family Welfare,
Government of India, Nirman Bhawan, New Delhi- 110011.
Draft rules
1. These rules may be called the Drugs and Cosmetics (8th Amendment) Rules, 2014.
2. In the Drugs and Cosmetics Rules, 1945,-
(a) in rule 96, in sub-rule (1), after clause (xii), the following clause shall be inserted, namely:-
“(xiii) Every vaccine preparation shall bear on its label the number of the new drug permission
granted by the licensing authority as defined in clause (b) of rule 21”.
(b) in rule 122E, in the Explanation, for clause (i), the following shall be substituted, namely:-
“(i) All vaccines, recombinant DNA (r-DNA) derived drugs and all New Drug Delivery Systems
including modified release dosage forms of a drug formulation shall be deemed to be new drugs
unless certified otherwise by the licensing authority as defined in clause (b) of rule 21”.
[F. No. X-11014/1/2014-DFQC]
ARUN K. PANDA, Jt. Secy.
Note.- The principal rules were published in the Gazette of India, vide notification No. F. 28-10/45-H (1) dated the
21st December, 1945 and last amended vide notification number G.S.R. 346(E) dated 21st May, 2014.
Printed by the Manager, Government of India Press, Ring Road, Mayapuri, New Delhi-110064
and Published by the Controller of Publications, Delhi-110054.