Executive Summary:
This notification announces a draft of amendments to the Drugs and Cosmetics Rules, 1945, concerning sterile solutions for parenteral administration manufactured for export by 100% export-oriented units. The draft rules are published for public consultation, with a 45-day period for submitting objections and suggestions. The amendments pertain to exemptions under Schedule K of the Drugs and Cosmetics Rules, 1945.
Key Points / Main Content:
* **Purpose:** To amend the Drugs and Cosmetics Rules, 1945.
* **Legal Basis:** Amendments are proposed under Section 12 and Section 33 of the Drugs and Cosmetics Act, 1940.
* **Consultation:** The draft rules are published for public consultation.
* **Objection Period:** A period of 45 days is given for submitting objections and suggestions from the date the draft rules are made available.
* **Submission of Feedback:** Objections and suggestions should be addressed to the Under Secretary Drugs, Ministry of Health and Family Welfare, or emailed to drugsdivmohfwgov.in.
* **Amendment Details:**
* In Schedule K of the Drugs and Cosmetics Rules, 1945, a new entry is inserted after serial number 35.
* Serial number 36 pertains to sterile solutions intended for parenteral administration with 100 ml in one container of the finished dosage form for single use.
* These solutions are exempt from Chapter IV of the Act and related rules, which require a license in Form 28D or 28DA from the Central Licence Approving Authority.
* This exemption is conditional: the drugs must be manufactured for export under a license granted by the State Licensing Authority for 100% export-oriented units.
* **Effective Date:** The rules will come into force upon their final publication in the Official Gazette.
Impact Analysis:
**Central Government:**
* *Impact:* Must consider objections and suggestions received during the consultation period and finalize the amendment.
* *Action Required:* Review and address feedback; publish the final amendment in the Official Gazette.
**Drug Manufacturers (100% Export-Oriented Units):**
* *Impact:* Potential exemption from certain licensing requirements (Form 28D or 28DA) under specific conditions for sterile solutions intended for parenteral administration.
* *Action Required:* Review the draft rules and assess eligibility for the exemption; submit objections or suggestions if necessary; comply with the conditions for exemption, including holding a State Licensing Authority-granted export license.
**State Licensing Authorities:**
* *Impact:* Responsible for granting licenses to 100% export-oriented units manufacturing sterile solutions intended for parenteral administration.
* *Action Required:* Ensure compliance with the amended rules when granting licenses; be aware of the new exemption conditions.
**Drugs Technical Advisory Board:**
* *Impact:* Consulted during the drafting of the rules.
* *Action Required:* N/A.
Key Entities Referenced
Drugs and Cosmetics Rules, 1945: A set of rules related to drugs and cosmetics, which is being amended by this notification.
Drugs and Cosmetics Act, 1940: The principal legislation governing drugs and cosmetics, which confers powers to make rules.
Drugs Technical Advisory Board: A board consulted during the amendment process of the Drugs and Cosmetics Rules.
Central Government: The governing body responsible for making the amendments to the Drugs and Cosmetics Rules.
Ministry of Health and Family Welfare: The government ministry responsible for health and family welfare.
New Delhi: The location of the Ministry of Health and Family Welfare, where objections and suggestions can be addressed.
Nirman Bhavan, New Delhi 110011: Address of the Ministry of Health and Family Welfare.
Schedule K: A schedule within the Drugs and Cosmetics Rules, 1945, where amendments are being made.
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4394 GI/2018 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
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[एफ. सं. ए< स.11014/10/2018-डीआर]
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MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 30th July, 2018
G.S.R. 719(E).—The following draft of certain 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 information of all persons likely to be affected thereby, and notice is hereby given that said draft rules will
be taken into consideration on or after the expiry of a period of forty-five days from the date on which copies of the
Gazette of India containing these draft rules are made available to the public.
Objections and suggestions which may be received from any person within the period specified above will be
considered by the Central Government.
Objections and suggestions, if any, may be addressed to the Under Secretary (Drugs), Ministry of Health and
Family Welfare, Government of India, Room No. 414 A, D Wing, Nirman Bhavan, New Delhi - 110011 or emailed at
drugsdiv-mohfw@gov.in.
DRAFT RULES
1. (1) These rules may be called the Drugs and Cosmetics (………. Amendment) Rules, 2018.
(2) They shall come into force on the date of their final publication in the Official Gazette.
2. In the Drugs and Cosmetics Rules, 1945, in Schedule K, after serial number 35 and the entries relating thereto,
the following serial number and entries shall be inserted, namely:-
Class of Drugs Extent and Conditions of Exemption
“36. Sterile solutions intended for parenteral The provisions of Chapter IV of the Act and rules thereunder which
administration with 100 ml in one container require them to obtain a licence in Form 28D or 28DA from the Central
of the finished dosage form for single use Licence Approving Authority subject to the condition that such drugs
manufactured for export by the hundred per have been manufactured for export purpose under a licence granted by the
cent export oriented units. State Licensing Authority.” .
[F.No. X.11014/10/2018-DR]
SUDHIR KUMAR, Jt. Secy.
Note: The principal rules were published in the Official Gazette vide notification No.F.28-10/45-H (1), dated
21st December, 1945 and last amended vide notification number G.S.R ………… (E), dated …………..
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.