**Executive Summary:**
This Office Memorandum addresses the misuse of Oxytocin in India and mandates special operations to prevent and detect its illegal manufacturing, sale, distribution, and import. Import of Oxytocin is prohibited effective April 24, 2018. Regulations regarding the manufacture of Oxytocin for domestic use will be enforced from July 1, 2018. The Drugs Controller General of India (DCGI) is directed to conduct these operations with police cooperation.
**Key Points / Main Content:**
* **Prohibition and Regulation of Oxytocin:**
* Import of Oxytocin is prohibited.
* Manufacture, sale, and distribution of Oxytocin are regulated to prevent misuse.
* **Manufacturing Guidelines:**
* Oxytocin formulations for domestic use are restricted to public sector undertakings or companies, and must have barcodes on the label.
* Oxytocin formulations for export can be manufactured by both public and private sector companies, and must have barcodes on the label.
* API (Active Pharmaceutical Ingredient) of Oxytocin must be supplied only to public sector manufacturers licensed under the Drugs and Cosmetics Rules, 1945, for domestic formulations.
* API of Oxytocin can be supplied to both public and private sector manufacturers licensed under the Drugs and Cosmetics Rules, 1945, for export formulations.
* **Distribution Guidelines:**
* Oxytocin formulations manufactured by public sector companies for domestic use must be supplied for human and veterinary use only to:
* Registered hospitals and clinics (public and private sectors), or
* Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP), Affordable Medicines and Reliable Implants for Treatment (AMRIT) outlets, or any other government entity specified by the Central Government.
* Sale of Oxytocin through retail chemists is prohibited.
* **Enforcement and Deadlines:**
* Regulations for Oxytocin manufacture for domestic use will be enforced from July 1, 2018.
* The ban on Oxytocin import is effective immediately from April 24, 2018.
* **Action Required:**
* The DCGI is directed to conduct special operations to prevent and detect illegal activities related to Oxytocin with police cooperation.
* Action taken must be reported to the CDSCO office at the earliest.
**Impact Analysis:**
* **Drugs Controller General of India (DCGI):**
* *Impact:* Responsible for conducting special operations to prevent and detect illegal activities related to Oxytocin.
* *Action Required:* Conduct special operations with police cooperation and report actions taken to the CDSCO office.
* **Public and Private Sector Oxytocin Manufacturers:**
* *Impact:* Manufacturing and supply chains are now regulated, with restrictions based on sector and end-use (domestic vs. export). Public sector companies are favored for domestic formulations.
* *Action Required:* Comply with manufacturing and distribution guidelines. Public sector manufacturers must prepare to meet domestic demand, and all manufacturers must ensure barcode compliance.
* **Hospitals, Clinics (Public & Private), PMBJP, AMRIT Outlets:**
* *Impact:* These are now the primary legal channels for sourcing Oxytocin for domestic use.
* *Action Required:* Establish direct supply relationships with public sector manufacturers or government-approved entities.
* **Retail Chemists:**
* *Impact:* Prohibited from selling Oxytocin.
* *Action Required:* Cease selling Oxytocin immediately.
* **Farmers and Dairy Owners:**
* *Impact:* Restricted access to Oxytocin for veterinary use, aiming to prevent misuse on milch animals.
* *Action Required:* Seek alternative veterinary solutions and comply with regulations.
* **Zonal/Sub-Zonal Offices & Port Offices of CDSCO:**
* *Impact:* Responsible for implementing and enforcing the regulations at their respective jurisdictions.
* *Action Required:* Implement and enforce the regulations, monitor compliance, and report any violations.
Key Entities Referenced
Directorate General of Health Services: An organization within the government responsible for health services.
Central Drugs Standard Control Organization: The national regulatory body for pharmaceuticals and medical devices in India.
Oxytocin: A drug whose manufacturing, import, sale, and distribution are being regulated to prevent misuse.
Ministry of Health and Family Welfare: A government ministry responsible for public health in India.
Drugs and Cosmetics Rules, 1945: A set of rules governing the regulation of drugs and cosmetics in India.
Pradhan Mantri Bhartiya Janaushadhi Pariyojana: A campaign launched by the Government of India to provide quality medicines at affordable prices to the masses.
Affordable Medicines and Reliable Implants for Treatment: An initiative to provide affordable medicines and implants.
Dr. S. Eswara Reddy: Drugs Controller General of India
File No. X-11026/103/2018-BD
Directorate General of Health Services
Central Drugs Standard Control Organization
FDA Bhawan, Kotla road, New Delhi
(Biological Division)
FDA Bhawan, Kotla Road
New Delhi-110011
Dated- \
Office Memorandum . .
Subject: Special operations to prevent and detect illegal manufacturing of (API,
formulations) and import of Oxytocin in India - regarding.
As you are aware, reports have appeared time to time in various fora about
misuse of Oxytocin in the country by the farmers and dairy owners to extract
milk from milch animals.
Cases of illegal manufacture, import and sale of the drug and its misuse by
the farmers or dairy owners have also been unearthed from time to time in
different parts of the country.
[he issue has been discussed in several meetings at highest level of
government and it has been decided that DCG(I) to conduct special operations to
prevent and detect illegal manufacturing of (API, formulations) and import of
Oxytocin in India with the cooperation of Police wherever required.
The Ministry of Health and Family Welfare has issued the Gazette
notifications vide GSR No.390 (E) dated 24.04.2018 to prohibit the import of
Oxytocin in public interest.
The Ministry of Health and Family Welfare has also issued Gazette
notifications vide GSR No.411 (E) dated 27.04.2018 to regulate and restrict the
manufacture. sale and distribution of Oxytocin in the country to prevent its misuse
by unauthorized persons or otherwise. The Central Government has regulated the
manufacture for sale or for distribution of Oxytocin under section 26A of the said
Act in the following manner:
l, Phe manufacture of Oxytocin formulations for domestic use shall be by public sector
undertakings or companies only and the label of the product shall bear barcodes.
IL. (he manufacture of Oxytocin formulations for export purposes shall be open to both
public and private sector companies and the packs of such manufacture for exports
shall bear barcodes.
ll. The manutactures of active pharmaceutical ingredient (API) of Oxytocin
shall supply the API only to the public sector manufacturers licensed under
the Drugs and Cosmetics Rules. 1945 for manufacture of formulations of the
‘ said drug for domestic use.
IV. The manufacturers of active pharmaceutical ingredient of Oxytocin shall supply the
said active pharmaceutical ingredient to the manufacturers in public and private sectorlicensed under the Drugs and Cosmetics Rules. 1945 for manufacture of formulations
of the said drug for export purpose.
V. The Oxytocin formulations manufactured by the public sector companies or
undertakings licensed under the Drugs and Cosmetics Rules. 1945 for domestic use
shall supply the formulations meant for human and veterinary use only.-
a) To the registered hospitals and clinics in public and private sector directly: or
(b) To the Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP) and Affordable
Medicines and Reliable Implants for Treatment (AMRIT) outlets or any other
Government entity which may be specified by the Central Government for this
purpose in the country which shall further supply the drug to the registered hospitals
and clinics in public and private sector.
VI. The Oxytocin in any form or name shall not be allowed to be sold through retail Chemist.
Phe regulations with regard manufacture of Oxytocin for domestic use will
come into force on 1° July 2018 as per GSR 411(E). However, the ban on import
takes immediate effect as per GSR 390 (E) dated 24.04.2018.
.
As decided at the highest level of government, you are hereby directed to conduct
special operations to prevent and detect illegal manufacturing. sale and distribution of
Oxytocin with the cooperation of Police wherever required. This matter should be given top
priority and the action taken in the matter should be forwarded to this office at the earliest.
Asp
S
(Dr. S. Eswara Reddy)
Drugs Controller General (India)
To
Zonal/Subzonal offices/all port offices of CDSCO.
Copy to-
1. PPS to JS (R), Ministry of Health and Family Welfare, Nirman Bhawan, New Delhi-
110011.
Chief Commissioners of customs of all port offices.
by
fhe Director NIT] Aayog (Health division) Government of India Sansad Marg. New
Delhi-110001
4. IP cell of CDSCO (HQ) for uploading in CDSCO website.
bo