Date: 2014-02-13Category: Extra OrdinaryState: Union GovernmentCountry: India
The Central Govt. hereby revokes the notification G.S.R. 378(E) dated 18th June, 2013 subject to the condition that manufacturers shall mention the following on their package insert and promotional literature of the drug.
Executive Summary:
This notification from the Ministry of Health and Family Welfare revokes the previous suspension on the manufacture, sale, and distribution of Analgin and all drug formulations containing Analgin for human use. The revocation is based on the recommendations of the Drugs Technical Advisory Board. However, manufacturers must include specific information on package inserts and promotional materials. The notification is effective as of February 13, 2014.
Key Points / Main Content:
* **Revocation of Suspension:**
* The Central Government revokes notification G.S.R. 378E, dated June 18, 2013, which had suspended Analgin.
* **Conditions for Revocation:**
* Manufacturers must include the following on package inserts and promotional literature:
* The drug is indicated for severe pain or pain due to tumor.
* The drug is indicated for bringing down temperature in refractory cases when other antipyretics fail.
* **Authority:**
* The decision is based on the recommendations of the Drugs Technical Advisory Board from its 65th meeting held on November 25, 2013.
Impact Analysis:
* **Manufacturers:**
* Impact: Can resume manufacture, sale, and distribution of Analgin formulations.
* Action Required: Must update package inserts and promotional literature with the specified indications for the drug.
* **Healthcare Professionals:**
* Impact: Can again prescribe Analgin, but need to be aware of the specific indications.
* **Patients:**
* Impact: Analgin becomes available again as a treatment option for severe pain, pain due to tumor, and refractory fever.
* **Regulatory Bodies:**
* Impact: Need to enforce the updated labeling requirements for Analgin products.
Key Entities Referenced
Analgin: A drug whose manufacture, sale, and distribution were initially suspended by the Central Government due to safety concerns, but later revoked subject to certain conditions.
Drugs and Cosmetic Act, 1940: Indian legislation that empowers the Central Government to regulate the manufacture, sale, and distribution of drugs and cosmetics. Section 26A is specifically referenced.
Ministry of Health and Family Welfare: The Indian government ministry responsible for health policy in India. The Department of Health and Family Welfare is explicitly mentioned.
Drugs Technical Advisory Board: A board that examined the issue of suspension of manufacture and sale of Analgin and recommended that the suspension of the drug should be revoked and allowed to be marketed subject to certain conditions.
G.S.R. 378 E: The notification number, dated 18th June, 2013, through which the Central Government initially suspended the manufacture for sale, sale and distribution of Analgin.
New Delhi: The location where the notification was issued, which is the capital of India.
Severe pain or pain due to tumor: Indication for use of Analgin as specified in the policy document
refractory cases: Condition under which Analgin can be used as an antipyretic
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592 GI/2014 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and family welfare )
NOTIFICATION
New Delhi, the 13th February, 2014
G.S.R. 86 (E).—Whereas the Central Government was satisfied that the use of the drug Analgin and all drug
formulations containing Analgin for human use was likely to involve risk to human beings and whereas safer
alternatives to the said drug are available;
Whereas, the Central Government was satisfied that it was necessary and expedient to regulate by way of
suspension, the manufacture for sale, sale and distribution of the said drugs in the country in public interest, and
accordingly in exercise of the powers conferred by Section 26A of the Drugs and Cosmetic Act, 1940 (23 of 1940), the
Central Government suspended the manufacture for sale, sale and distribution of Analgin and all formulations
containing Analgin for human use through the notification number G.S.R. 378 (E), dated 18th June, 2013;
Whereas, the Drugs Technical Advisory Board has examined the issue of suspension of manufacture and sale
of the said drug on 25th November, 2013 in its 65th meeting and recommended that the suspension of the drug should
be revoked and allowed to be marketed subject to certain conditions which the manufacturers shall mention on their
package insert and promotional literature of the drug;
Now, therefore, on the basis of the recommendations of the Drugs Technical Advisory Board, the Central
Government hereby revokes the notification G.S.R. 378(E) dated 18th June, 2013 subject to the condition that
manufacturers shall mention the following on their package insert and promotional literature of the drug:—
“The drug is indicated for Severe pain or pain due to tumor and also for bringing down temperature in
refractory cases when other antipyretics fail to do so.”.
[F.No. 4-01/2011-DC/Analgin]
ARUN K. PANDA, Jt. Secy.
Printed by the Manager, Government of India Press, Ring Road, Mayapuri, New Delhi-110064
and Published by the Controller of Publications, Delhi-110054.