**Executive Summary:**
This notification, issued by the Ministry of Health and Family Welfare on July 11, 2014, prohibits the manufacture for sale, sale, and distribution of the fixed-dose combination of Flupenthixol and Melitracen for human use in India, effective immediately. This decision follows a review process prompted by a High Court order and is based on the recommendation of the Drugs Technical Advisory Board, which advised discontinuing the drug's use due to safety concerns and the availability of safer alternatives. The legal basis for this action is Section 26A of the Drugs and Cosmetics Act, 1940.
**Key Points / Main Content:**
* **Prohibition of Drug:**
* The manufacture for sale, sale, and distribution of the fixed-dose combination of Flupenthixol and Melitracen for human use is prohibited.
* The prohibition is effective immediately.
* **Legal Basis and Authority:**
* The action is taken under Section 26A of the Drugs and Cosmetics Act, 1940.
* The decision is based on the recommendations of the Drugs Technical Advisory Board.
* The Central Government is exercising its powers to regulate drugs in the public interest.
* **Context and Background:**
* The Central Government previously suspended the drug via notification G.S.R. 377E dated 18th June, 2013.
* The High Court of Karnataka quashed the earlier notification and remanded the matter for reconsideration.
* The Drugs Technical Advisory Board reviewed the matter in its 65th meeting on 25th November, 2013.
* The Board recommended discontinuing the use of the drug due to safety concerns and the availability of safer alternatives.
**Impact Analysis**
**Manufacturers, Sellers, and Distributors of Flupenthixol and Melitracen:**
* *Impact:* Prohibition of manufacturing, selling, and distributing the specified drug combination will likely lead to financial losses and require adjustments to product lines.
* *Action Required:* Immediately cease all manufacturing, sales, and distribution activities related to the fixed-dose combination of Flupenthixol and Melitracen.
**Healthcare Professionals:**
* *Impact:* Doctors must discontinue prescribing the drug combination.
* *Action Required:* Discontinue prescribing the fixed-dose combination of Flupenthixol and Melitracen and switch patients to safer alternatives.
**Patients:**
* *Impact:* Patients currently using the drug combination will need to consult with their healthcare providers for alternative treatments.
* *Action Required:* Consult with healthcare providers to discuss alternative treatment options.
**Regulatory Authorities:**
* *Impact:* Responsible for enforcing the prohibition.
* *Action Required:* Enforce the ban on the manufacture, sale, and distribution of the drug.
Key Entities Referenced
Flupenthixol and Melitracen: A fixed-dose combination drug whose manufacture, sale, and distribution are being regulated due to potential risks to human health.
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 mentioned as the source of power for the order.
Ministry of Health and Family Welfare: The Indian government ministry responsible for health policy in India. It issued the notification.
New Delhi: The location where the notification was issued.
Drugs Technical Advisory Board: A statutory body under the Drugs and Cosmetics Act, 1940, that advises the government on technical matters related to drugs and cosmetics. It recommended discontinuing the drug Flupenthixol and Melitracen.
High Court of Karnataka: The High Court of the state of Karnataka which quashed an earlier notification regarding the drug and remanded the matter for reconsideration.
18th June, 2013: Date of the original notification regarding the suspension of the drug, which was later quashed by the High Court of Karnataka.
25th November, 2013: Date of the 65th meeting of the Drugs Technical Advisory Board, during which the suspension of Flupenthixol and Melitracen was discussed.
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2842 GI/2014 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
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[फा. सं. 4-01/2011-डीसी (पाट,-डीनसीट (Deanxit)]
अLण कु. पMड ा, संयु त सिचव
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 11th July, 2014
G.S.R. 498(E).—Whereas the Central Government was satisfied that the use of the drug ‘fixed dose
combination of Flupenthixol and Melitracen’ 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 drug 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
fixed dose combination of Flupenthixol and Melitracen for human use through the notification number
G.S.R. 377(E) dated 18th June, 2013;
Whereas the Hon’ble High Court of Karnataka in their order dated 14th August, 2013 in the case of
WP No. 28354/2013 (GM-RES) quashed the notification and remanded the matter back to reconsider afresh
by the respondents and take a decision one way or other in accordance with the Law.
Whereas, the Drugs Technical Advisory Board, a statutory body under the Drugs and Cosmetics Act,
1940, has examined the issue of suspension of manufacture and sale of the said drug in its 65th meeting on
25th November, 2013 and recommended that the use of the drug should be discontinued from the country.
Now, therefore, on the basis of the recommendations of the Drugs Technical Advisory Board and in
exercise of the powers conferred by Section 26A of the Drugs and Cosmetic Act, 1940 (23 of 1940), the
Central Government hereby prohibits the manufacture for sale, sale and distribution of the following drug
with immediate effect :—
“Fixed dose combination of Flupenthixol and Melitracen for human use” .
[F. No. 4-01/2011-DC (Pt.Deanxit)]
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.