**Summary:**
This office memorandum, reference number BDVET.CELL 042017, issued by the Directorate General of Health Services, Central Drugs Standard Control Organization (CDSCO), addresses the need for strict regulatory control over the manufacture, sale, and distribution of oxytocin, and to curb its misuse. Following a meeting held on March 14, 2017, by the Secretary, Health and Family Welfare, Ministry of Health and Family Welfare, a decision was made to establish a mechanism within CDSCO for receiving complaints regarding the illegal production and misuse of oxytocin nationwide.
All Zonal, Sub-Zonal, and Port offices of CDSCO are directed to create systems for receiving complaints via email, complaint boxes, or other means, and to address these complaints appropriately. These offices are required to forward a monthly report to CDSCO HQ, addressed to Mr. S. Dey, DDC I, to ensure compliance with the Drugs and Cosmetics Act, 1940, and Rules 1945, regarding the manufacture of oxytocin for both human and animal use, and to effectively curb its misuse. The directive is issued by Dr. G. N. Singh, Drugs Controller General India.
Key Entities Referenced
Central Drugs Standard Control Organization: A national regulatory body under the Directorate General of Health Services, Ministry of Health and Family Welfare, responsible for drug regulation in India.
Oxytocin: A drug whose manufacture, sale, and distribution are being strictly regulated to curb its misuse.
Ministry of Health and Family Welfare: The government ministry responsible for health policy in India.
High Court of Himachal Pradesh: The High Court of the state of Himachal Pradesh in India, which issued a judgment related to oxytocin manufacturing.
Drugs and Cosmetics Act, 1940: An act of the Parliament of India that regulates the import, manufacture, distribution and sale of drugs and cosmetics.
Drugs and Cosmetics Rules, 1945: The rules framed under the Drugs and Cosmetics Act, 1940, providing detailed regulations for drugs and cosmetics.
Dr. G. N. Singh: The Drugs Controller General of India at the time of the memorandum.
S. Dey: DDC I at CDSCO HQ, to whom monthly reports should be forwarded.
F. No: BD/VET.CELL/ 04-2017
Directorate of General of Health Services
Central Drugs Standard Control Organization
FDA Bhawan, Kotla Road, New Delhi
(O/o DCG (I))
OFFICE MEMORANDUM SQ MrnrQ 2017
Subject: Strict regulatory control over manufacture, sale and distribution of oxytocin
and to curb its misuse -reg.
The Secretary, Health and Family Welfare, Ministry of Health and Family Welfare took
a meeting on 14.03.2017 to take stock of situation relating to restricting and regulating
manufacturing of oxytocin and to permit its manufacturing in PSU in compliance to the
judgment of the High Court of Himachal Pradesh.
It was decided in the meeting that a mechanism should be created in CDSCO to
receive complaints regarding illegal production of oxytocin and its misuse in the country.
All the Zonal / Sub- Zonal / Port offices of CDSCO are hereby directed to create a
mechanism of receiving complaints regarding illegal production / import of oxytocin and its
misuse in the country through E-mail or other means including a Complaint Box in their
respective offices as well as a system to address such complaints.
A monthly report in this regard should be forwarded to CDSCO (HQ), (with attention to
Mr. S. Dey, DDC (I) to ensure that the drug is manufactured in the country for human and
animals in compliance to the regulatory provisions of the Drugs and Cosmetics Act, 1940 and
Rules 1945 made thereunder and its misuse is curbed.
(Dr. G. N. Singh)
Drugs Controller Genefal (India)
To
All Zonal/ Sub-Zonal / Port offices of CDSCO