Executive Summary:
This notification concerns draft rules further amending the Drugs and Cosmetics Rules of 1945. It includes amendments related to provisos concerning drug manufacturing and importation. The draft rules are published for public feedback, which must be submitted within forty-five days of the gazette's publication.
Key Points / Main Content:
Amendments to the Drugs and Cosmetics Rules, 1945:
* Rule 105 Amendments:
* In subrule 2, the second and third provisos are to be reworded by substituting "Provided also that" and "Provided further that" for each other respectively.
* A new proviso is inserted, mandating that Diclofenac injection for human use must be in a single unit dose pack.
* Rule 122A Amendments (Import of Vaccines/Biological Products):
* After subrule 3, a new subrule 4 is inserted.
* If any changes occur after the import license is granted (manufacturing process, facility, site, batch size, shelf life, presentation, etc.) that may affect the vaccine/product's identity, strength, quality, or purity, the importer must apply to the Licensing Authority (as per rule 21b).
* The application must include technical data for approval and be accompanied by a fee of fifteen thousand rupees.
* Rule 122B Amendments (Manufacturing of Vaccines/Biological Products):
* After subrule 3, a new subrule 4 is inserted.
* If any changes occur after the manufacturing license is granted (manufacturing process, facility, site, batch size, shelf life, presentation, etc.) that may affect the vaccine/product's identity, strength, quality, or purity, the manufacturer must apply to the Licensing Authority (as per rule 21b).
* The application must include technical data for approval and be accompanied by a fee of fifteen thousand rupees.
Impact Analysis:
* Drug Manufacturers:
* Impact: Manufacturers of Diclofenac injections must comply with single unit dose packaging. Manufacturers of vaccines/biological products must apply for approval for certain post-licensing changes.
* Action Required: Modify packaging for Diclofenac injections. Submit applications with technical data and fees for changes affecting vaccine/biological product characteristics.
* Importers of Vaccines/Biological Products:
* Impact: Importers must apply for approval for certain post-licensing changes that may affect the vaccine/product's identity, strength, quality, or purity.
* Action Required: Submit applications with technical data and fees for changes affecting imported vaccine/biological product characteristics.
* Central Government (Ministry of Health and Family Welfare):
* Impact: Responsible for considering objections/suggestions on the draft rules.
* Action Required: Review and consider feedback on the draft rules submitted within the specified timeframe.
* Public:
* Impact: Potentially affected by changes in drug manufacturing and import regulations.
* Action Required: Submit any objections or suggestions on the proposed draft rules in writing to the Ministry of Health and Family Welfare within forty-five days of the gazette's publication.
Key Entities Referenced
Drugs and Cosmetics Rules, 1945: The principal rules being amended by this notification.
Drugs and Cosmetics Act, 1940: The Act that confers powers to the Central Government to make rules.
Drugs Technical Advisory Board: An advisory board consulted before amending the Drugs and Cosmetics Rules.
Ministry of Health and Family Welfare: The ministry to which objections or suggestions regarding the draft rules can be submitted.
Nirman Bhawan, New Delhi: Address of the Ministry of Health and Family Welfare where objections can be sent.
Drugs and Cosmetics 9th Amendment Rules, 2014: The title of the new rules being introduced.
Diclofenac injection: Specific drug mentioned with packaging requirements for human use.
Licensing Authority: Authority to which the importer/manufacturer shall submit application for approval
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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. 503(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 will be taken
into consideration after the expiry of a period of forty-five days from the date on which the copies of the Official Gazette of
India in which this notification is published, are made available to the public;
Any person interested in making any objection or suggestion on the proposed draft rules may do so in writing for
consideration of the Central Government within the period so specified through post 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 (9th Amendment) Rules, 2014.
2. In the Drugs and Cosmetics Rules, 1945,-
(a) in rule 105, in sub-rule (2),-
(i) in the second proviso, for the words “Provided also that”, the words “Provided further that” shall be
substituted;
(ii) in the third proviso, for the words “Provided further that”, the words “Provided also that” shall be
substituted;
(iii) after the third proviso, the following proviso shall be inserted namely:-
“Provided also that Diclofenac injection for human use shall be in single unit dose pack only.” ;
(b) in rule 122A, after sub-rule (3), and before the proviso, the following sub-rule shall be inserted, namely:-
“(4) If there is a change, such as manufacturing process, manufacturing facility, site of manufacture, batch size, shelf
life, presentation or any other change which may affect its identity, strength, quality, purity, after granting
permission for importing a vaccine or biological product as a new drug, the importer shall submit application to the
Licensing Authority, as referred to in clause (b) of rule 21, duly supported by technical data for the purpose of
approval and accompanied by a fee of rupees fifteen thousand.”
(c) in rule 122B, after sub-rule (3), and before the proviso, the following sub-rule shall be inserted, namely:-
“(4) If there is a change, such as manufacturing process, manufacturing facility, site of manufacture, batch size, shelf
life, presentation or any other change which may affect its identity, strength, quality, purity, after granting
permission for manufacturing a vaccine or biological product as a new drug, the manufacturer shall submit
application to the Licensing Authority, as referred to in clause (b) of rule 21, duly supported by technical data for the
purpose of approval and accompanied by a fee of rupees fifteen thousand.”
[F. No. 18-6/2013-DC]
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 published in the Gazette of India, Extraordinary, Part II, Section 3,
Sub-section (i), vide G.S.R. 346(E), dated the 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.