Executive Summary:
This notification, issued by the Ministry of Health and Family Welfare, prohibits the marketing of Buclizine as an appetite stimulant due to lack of clinical evidence and potential risks. The decision follows recommendations from the Subject Expert Committee and Drugs Technical Advisory Board. Manufacturers must now label Buclizine products with a warning against its use as an appetite stimulant, effective December 13, 2018.
Key Points / Main Content:
* **Prohibition of Buclizine as Appetite Stimulant:**
* The Central Government prohibits the manufacture, sale, and distribution of Buclizine for use as an appetite stimulant.
* This decision is based on the lack of rational justification for its use as an appetite stimulant and potential risks to human beings.
* **Recommendations and Examinations:**
* The Subject Expert Committee found no clinical trial study reports justifying Buclizine's use as an appetite stimulant.
* The Drugs Technical Advisory Board recommended prohibiting Buclizine for appetite stimulation, but supported continued marketing for allergic conditions and motion sickness.
* **Labeling Requirements:**
* Manufacturers must label Buclizine containers, package inserts, and promotional literature with the words "Not to be used as appetite stimulant."
* This labeling requirement is mandated under section 26A of the Drugs and Cosmetics Act, 1940.
Impact Analysis:
* **Manufacturers of Buclizine:**
* *Impact:* Restricted from marketing Buclizine as an appetite stimulant; must comply with new labeling requirements.
* *Action Required:* Update labels, package inserts, and promotional materials to include the warning "Not to be used as appetite stimulant." Cease marketing the drug for appetite stimulation purposes.
* **Healthcare Professionals:**
* *Impact:* Need to be aware of the restricted use of Buclizine and avoid prescribing it as an appetite stimulant.
* *Action Required:* Consider alternative treatments for patients seeking appetite stimulants.
* **Consumers:**
* *Impact:* Should not use Buclizine as an appetite stimulant due to its lack of therapeutic value for this purpose and potential risks.
* *Action Required:* Consult healthcare professionals for appropriate appetite-related treatments.
* **Regulatory Bodies:**
* *Impact:* Required to enforce the new regulations and ensure compliance by manufacturers.
* *Action Required:* Monitor the market to ensure Buclizine is not being marketed or sold as an appetite stimulant and that proper labeling is in place.
Key Entities Referenced
Buclizine: A drug whose use as an appetite stimulant for human use is being regulated by the Central Government due to lack of clinical trial study report on human beings and potential risk to human beings.
Drugs and Cosmetics Act, 1940: A law that confers powers to the Central Government to regulate the manufacture, sale, or distribution of drugs.
Ministry of Health and Family Welfare: The government ministry responsible for health and family welfare policies, which issued the notification regarding Buclizine.
Department of Health and Family Welfare: The department within the Ministry of Health and Family Welfare that is involved in the notification process.
Subject Expert Committee: A committee constituted by the Central Government that examined the matter of Buclizine as an appetite stimulant.
Drugs Technical Advisory Board: A board that considered the matter of Buclizine and recommended prohibiting its manufacture, sale, and distribution as an appetite stimulant.
New Delhi: The city in Delhi where the notification was issued.
Sudhir Kumar: Jt. Secy. who is responsible for the notification.
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सुधीर कुमार, संयु(cid:21) त सिचव
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 13th December, 2018.
S.O. 6161(E).—Whereas it has been brought to the notice of the Central Government that the use of the drug
Buclizine as appetite stimulant for human use is not rational;
And, whereas, the matter has been examined by the Subject Expert Committee constituted by the Central
Government and the said Committee has stated that no clinical trial study report on human beings to justify the use of the
Buclizine as an appetite stimulant has been produced by the manufacturers and hence, the said committee has not
recommended the continued marketing of the aforesaid drug as an appetite stimulant;
And, whereas, the Drugs Technical Advisory Board has also considered the said matter and recommended for
prohibiting the manufacture, sale and distribution of Buclizine for the indication “as appetite stimulant” in public interest
and continuing the marketing for the indications “symptomatic treatment of various allergic conditions (rhinitis,
conjunctivitis and urticaria) and for prevention and treatment of motion sickness”;
And, whereas, after examination of the recommendations of the Subject Expert Committee and Drugs Technical
Advisory Board, the Central Government is satisfied that the use of said drug Buclizine do not have any therapeutic value
claimed for as an appetite stimulant and is likely to involve risk to human beings;
Now, therefore, in exercise of the powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23
of 1940), the Central Government, on being satisfied that it is hereby necessary and expedient in public interest to do so
regulates the manufacture, sale or distribution of Buclizine and its formulations for use in human beings subject to the
conditions that the manufacturer shall label the container of Buclizine and its formulation and also mention in
conspicuous manner on the package insert and promotional literature of Buclizine and its formulation with the words
“Not to be used as appetite stimulant”.
[F.No. X.11014/18/2017-DRS]
SUDHIR KUMAR, Jt. Secy.
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.