Executive Summary:
This notification, issued by the Ministry of Health and Family Welfare on February 17, 2017, rescinds a previous suspension on the manufacture, sale, and distribution of letrozole for induction of ovulation in anovulatory infertility. The rescission follows recommendations from the Indian Council for Medical Research and the Drugs Technical Advisory Board. It is effective immediately, except for actions already taken or omitted before this rescission.
Key Points / Main Content:
* **Rescission of Previous Notification:**
* The notification G.S.R. 752E, dated October 12, 2011, which suspended the manufacture, sale, and distribution of letrozole for induction of ovulation in anovulatory infertility, is rescinded.
* **Basis for Rescission:**
* The Indian Council for Medical Research conducted a systematic review and meta-analysis, recommending the revocation of the suspension.
* The Drugs Technical Advisory Board, in its Seventy-fifth meeting on January 3, 2017, also recommended revoking the suspension.
* **Approval for Use:**
* Letrozole is now allowed for induction of ovulation in anovulatory infertility.
Impact Analysis:
* **Manufacturers and Distributors of Letrozole:**
* Impact: Can now manufacture, sell, and distribute letrozole for the specified use without the previous restrictions.
* Action Required: Ensure compliance with all other applicable regulations and guidelines for the manufacture, sale, and distribution of drugs.
* **Medical Professionals:**
* Impact: Can now prescribe letrozole for induction of ovulation in anovulatory infertility.
* Action Required: Stay informed about the latest research and guidelines regarding the use of letrozole and monitor patients accordingly.
* **Patients with Anovulatory Infertility:**
* Impact: Have access to letrozole as a treatment option for induction of ovulation.
* Action Required: Consult with medical professionals to determine if letrozole is an appropriate treatment option.
* **Regulatory Authorities (e.g., Drug Controllers):**
* Impact: The previous restrictions on letrozole are lifted, requiring adjustments in monitoring and enforcement activities.
* Action Required: Update relevant documentation and procedures to reflect the rescission of the notification and monitor the manufacture, sale, and distribution of letrozole accordingly.
Key Entities Referenced
Drugs and Cosmetics Act, 1940: A legislative act referred to in the notification regarding the powers conferred to the Central Government.
Ministry of Health and Family Welfare: The Indian government ministry responsible for health and family welfare policies; the publisher of the notification.
Letrozole: A drug whose manufacture, sale, and distribution for induction of ovulation in anovulatory infertility was initially suspended and subsequently revoked.
Indian Council for Medical Research: An organization in the Central Government that conducted a systematic review and meta-analysis of Letrozole.
Drugs Technical Advisory Board: A board that examined the suspension of Letrozole and recommended its revocation.
New Delhi: The location where the notification was issued.
G.S.R. 752E: The notification number, dated 12th October 2011, that initially suspended the manufacture, sale and distribution of Letrozole.
Section 26A: Section of the Drugs and Cosmetics Act, 1940 that gives power to central government.
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फा. सं. ए_स.11014/4/2017-डी.आर.
कु(cid:11)दन लाल शमाK, संयु' सिचव
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 17th February, 2017
G.S.R. 145(E).—Whereas the Central Government had in exercise of the powers conferred by section 26A of
the Drugs and Cosmetics Act, 1940 (23 of 1940), suspended the manufacture for sale, sale and distribution of letrozole
for induction of ovulation in anovulatory infertility vide the notification of the Government of India in the Ministry of
Health and Family Welfare, Department of Health and Family Welfare, published in the Gazette of India, Extraordinary,
Part II, Section 3, Sub-section (i), vide number G.S.R. 752(E), dated the 12th October, 2011, after taking note of the fact
that the use of the drug letrozole for induction of ovulation in anovulatory infertility was likely to involve risk to human
beings;
And whereas, the Indian Council for Medical Research in the Central Government conducted a systematic
review and meta analysis including studies in India in respect of the drug letrozole for induction of ovulation in
anovulatory infertility and whereas, the expert committee of the Indian Council for Medical Research recommended that
suspension of manufacture and sale of the said drug may be revoked;
And whereas, the Drugs Technical Advisory Board has now examined the issue of suspension of manufacture
and sale of the said drug on 3rd January, 2017 in its Seventy-fifth meeting and recommended that the suspension of
manufacture, sale and distribution of the said drug may be revoked and the drug be allowed for induction of ovulation in
anovulatory infertility;
Now, therefore, the Central Government in exercise of the powers conferred by section 26A of the said Act,
hereby rescinds the notification of the Government of India in the Ministry of Health and Family Welfare, Department of
Health and Family Welfare, published in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i), vide
G.S.R. 752(E), dated the 12th October, 2011 with immediate effect, except as respects things done or omitted to be done
before such rescission.
[F. No. X.11014/4/2017-DR]
K. L. SHARMA, 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.