**Executive Summary:**
This policy addresses the misuse of Oxytocin in India, specifically its illegal manufacture, import, and sale. It mandates special operations to prevent and detect these illegal activities, involving cooperation with the police where necessary. The import of Oxytocin is prohibited immediately, while regulations on domestic manufacture came into effect on July 1, 2018.
**Key Points / Main Content:**
* **Import Prohibition:**
* Import of Oxytocin is prohibited with immediate effect (GSR No. 390 E dated 24.04.2018).
* **Manufacturing Regulations:**
* Domestic manufacturing of Oxytocin formulations is restricted to public sector undertakings or companies.
* Labels of Oxytocin products for domestic use must bear barcodes.
* Manufacturing for export is open to both public and private sector companies; export packs must have barcodes.
* Manufacturers of Oxytocin API must supply API only to public sector manufacturers licensed under the Drugs and Cosmetics Rules, 1945 for domestic formulations.
* Manufacturers of Oxytocin API can supply API to both public and private sector companies licensed under the Drugs and Cosmetics Rules, 1945 for export formulations.
* **Distribution Regulations:**
* Oxytocin formulations manufactured by public sector companies for domestic use must be supplied for human and veterinary use to:
* Registered hospitals and clinics (public and private sectors).
* Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP) and Affordable Medicines and Reliable Implants for Treatment (AMRIT) outlets, or other specified government entities for further distribution to registered hospitals and clinics.
* Sale of Oxytocin through retail chemists is prohibited.
* Regulations for domestic manufacturing came into effect on July 1, 2018 (GSR 411E).
**Impact Analysis:**
* **State Drugs Controllers:**
* *Impact:* Responsible for conducting special operations to prevent and detect illegal manufacturing, sale, and distribution of Oxytocin.
* *Action Required:* Conduct special operations with police cooperation where needed and forward details of actions taken to the Drugs Controller General of India.
* **Public Sector Undertakings/Companies:**
* *Impact:* Restricted to manufacturing Oxytocin formulations for domestic use and must ensure products bear barcodes.
* *Action Required:* Comply with manufacturing and supply regulations, including barcode requirements.
* **Private Sector Companies:**
* *Impact:* Allowed to manufacture Oxytocin formulations for export purposes only and must ensure export packs bear barcodes.
* *Action Required:* Comply with manufacturing regulations, including barcode requirements for export products.
* **API Manufacturers:**
* *Impact:* Must adhere to specific supply restrictions based on whether the final formulation is for domestic or export use.
* *Action Required:* Supply API only to authorized manufacturers as per the policy guidelines.
* **Hospitals and Clinics (Public and Private):**
* *Impact:* Will receive Oxytocin formulations directly from public sector manufacturers or through designated government outlets.
* *Action Required:* Ensure they source Oxytocin only from authorized channels.
Key Entities Referenced
Oxytocin: A drug whose illegal manufacturing, import, sale, and misuse is being addressed by special operations.
Directorate General of Health Services: An organization under which Central Drugs Standard Control Organization operates.
Central Drugs Standard Control Organization: A regulatory body responsible for controlling drugs standards; the sender of the notification.
Ministry of Health and Family Welfare: The government ministry that issued Gazette notifications regarding Oxytocin.
GSR No.390 E: Gazette notification that prohibits the import of Oxytocin.
GSR No.411 E: Gazette notification that regulates and restricts the manufacture, sale and distribution of Oxytocin.
Drugs and Cosmetics Rules, 1945: The rules under which Oxytocin manufacture is licensed.
New Delhi, Delhi: Location of FDA Bhawan, Ministry of Health and Family Welfare and NITI Aayog.
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- i
To
;
The All State Drugs Controllers,
Subject: Special operations to prevent and detect illegal manufacturing of (API,
formulations) and import of Oxytocin in India - regarding.
Sir / Madam,
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 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.
(he 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:
iC lhe 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.
Il. The manufactures 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 sector
licensed 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 clinies in public and private sector.
VI. The Oxytocin imany form or name shall not be allowed to be sold through retail Chemist.
The regulations with regard manufacture of Oxytocin for domestic use will
come into foree 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 requested to conduct
special operations to prevent and detect illegal manufacturing, sale and distribution of
Oxytocin with the cooperation of Police wherever required.
Details of action taken in the matter may please be forwarded to this office for further
action,
Yours faithfully.
(Dr. S. Eswara Reddy)
Drugs Controller General (India)
Copy to-
I. PPS to JS (R), Ministry of Health and Family Welfare. Nirman Bhawan, New Delhi-
110011,
Chief Commissioners of customs of GW all port offices.
The Director NIT] Aayog (Health division) Government of India Sansad Marg, New
Delhi-110001
+. TT cell of CDSCO (HQ) for uploading in CDSCO website.
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