**Executive Summary:**
This public notice from the Central Drugs Standard Control Organization (CDSCO) addresses the misuse of Oxytocin in India. It outlines measures taken to regulate Oxytocin, including restrictions on its import, manufacture, sale, and distribution. Stakeholders are requested to provide comments and suggestions on the proposals to curb misuse within 15 days of the notice date (February 28, 2018).
**Key Points / Main Content:**
* **Background:**
* Reports of Oxytocin misuse by farmers and dairy owners to extract milk from animals.
* CDSCO and Ministry of Health and Family Welfare have implemented measures to prevent misuse.
* **Existing Regulations:**
* Oxytocin is a Schedule H drug, requiring a Registered Medical Practitioner's prescription for retail sale.
* Oxytocin Injection must be packed in single-unit blister packs since April 2001.
* Manufacturers of bulk Oxytocin can only supply the active pharmaceutical ingredient to licensed formulation manufacturers (since January 17, 2014).
* Formulations for veterinary use can only be sold to veterinary hospitals (since January 17, 2014).
* **Proposed Measures (Under Consideration):**
* Prohibit the import of Oxytocin and its formulations for both human and animal use.
* Regulate and restrict Oxytocin formulations for human use to supply only registered hospitals and clinics (public and private).
* Implement a barcoding system for Oxytocin formulations to ensure track and trace.
* Restrict Oxytocin formulation manufacturing to public sector units only.
* The above proposals will not apply to Oxytocin meant for export.
* **Call for Stakeholder Input:**
* All stakeholders are requested to forward their comments/suggestions on the above proposals.
* Submit comments via email to dcinic.in or in hard copies to the Oo DCGI, CDSCO, FDA Bhawan, Kotla Road, New Delhi 110002.
* Deadline for submission is within 15 days of the notice date (February 28, 2018).
**Impact Analysis:**
* **Oxytocin Manufacturers:**
* *Impact:* Potential changes to manufacturing, import, and distribution processes. May be restricted to public sector units.
* *Action Required:* Provide comments/suggestions on the proposed measures to the CDSCO within 15 days of the notice.
* **Hospitals and Clinics (Public and Private):**
* *Impact:* Potential changes to how Oxytocin is supplied and accessed. May be the only entities authorized to receive Oxytocin formulations.
* *Action Required:* Provide comments/suggestions on the proposed measures to the CDSCO within 15 days of the notice.
* **Veterinary Hospitals:**
* *Impact:* May continue to be the only entities authorized to purchase veterinary Oxytocin formulations.
* *Action Required:* Provide comments/suggestions on the proposed measures to the CDSCO within 15 days of the notice.
* **Farmers and Dairy Owners:**
* *Impact:* Aim to prevent Oxytocin misuse in animals.
* *Action Required:* N/A (This is the group the policy is targeting).
* **General Public:**
* *Impact:* Potential impact on access to Oxytocin for legitimate medical needs.
* *Action Required:* Provide comments/suggestions on the proposed measures to the CDSCO within 15 days of the notice.
* **Importers of Oxytocin:**
* *Impact:* Imports may be prohibited.
* *Action Required:* Provide comments/suggestions on the proposed measures to the CDSCO within 15 days of the notice.
Key Entities Referenced
Oxytocin: A drug whose import, manufacture, sale, and distribution are being restricted to curb its misuse, particularly in the context of dairy farming.
Central Drugs Standard Control Organisation CDSCO: A regulatory body involved in taking measures to prevent the misuse of Oxytocin in India.
Ministry of Health and Family Welfare: The government ministry responsible for health and family welfare, which has taken measures to prevent the misuse of Oxytocin.
Drugs and Cosmetics Rules, 1945: A set of rules under which Oxytocin is included in Schedule H, requiring it to be sold under prescription.
Drugs and Cosmetics Act, 1940: The legislation under which restrictions have been placed on the manufacture, sale, and distribution of Oxytocin.
High Court of Himachal Pradesh: The court that directed consideration of restricting Oxytocin manufacture to public sector companies.
Karnataka Antibiotics and Pharmaceuticals Limited KAPL Bangalore, Karnataka: A public sector company considered for restricting the manufacture of Oxytocin.
Dr.S.Eswara Reddy: Drugs Controller General India.
File No: X-11026/40/2018-BD
Directorate General of Health Services
Central Drugs Standard Control Organization
FDA Bhawan, Kotla road, New Delhi
(O/o DCG (I)
PUBLIC NOTICE
28 February, 2018.
Sub: Restriction on import, manufacture, sale and distribution of
Oxytocin to curb its misuse - regarding
Reports have appeared from 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.
2. Central Drugs Standard Control Organisation (CDSCO) and Ministry of
Health and Family Welfare have taken various measures to prevent the
misuse of the drug.
3. Oxytocin is included in Schedule H to the Drugs & Cosmetics Rules,
1945, requiring that the drug should be sold by retail under the prescription
of a Registered Medical Practitioner only.
4. To avoid bulk sale of Oxytocin injection, a provision was made under
the said Rules in April 2001 that the Oxytocin Injection shall be packed in
single unit blister pack only.
5. The manufacture for sale, sale or for distribution of the drug have also
been restricted on 17-01-2014 under Section 26A of the Drugs and
Cosmetics Act, 1940 providing that;
i. The manufacturers of bulk Oxytocin drug shall supply the active
pharmaceutical ingredient only to the manufacturers licensed
under the Drugs and Cosmetics Rules, 1945 for manufacture of
formulations of the said drug.
ii. The formulations meant for veterinary use shall be sold to the
veterinary hospitals only.
6. Hon’ble High Court of Himachal Pradesh in its order dated 15-03-
2016 in CWPIL No. 16 of 2014 has directed to consider the feasibility of
restricting the manufacture of Oxytocin only in public sector companies.7. Accordingly, Ministry of Health and Family Welfare has taken up the
matter with the Department of Pharmaceuticals for restricting the
manufacture of Oxytocin in Karnataka Antibiotics and Pharmaceuticals
Limited (KAPL) Bangalore.
8. As the whole issue of Oxytocin is of paramount importance for
protection of human and animal health, following proposals are under
consideration to curb its misuse.
i. To prohibit the import of the Oxytocin and its formulations for
human use as well as animal use under section 10A of the Drugs
and Cosmetics Act, 1940.
ii. To regulate and restrict the Oxytocin formulations for human use
under Section 26A of the Drugs and Cosmetics Act, 1940 so that
the drug is supplied only to registered hospitals and clinics in
public and private sector.
ili, To adopt bar-coding system for manufacture of Oxytocin
formulations so as to ensure track and traceability of the product to
avoid its misuse.
iv. Manufacturing of Oxytocin (formulation) shall be restricted in
public sector units only.
However, above proposals shall not be applicable for Oxytocin meant for
export purpose.
9. All the stakeholders are requested to forward their comments /
suggestions on the above proposals through email at dci@nic.in or in hard
copies to the O/o DCG(I), CDSCO, FDA Bhawan, Kotla Road, New Delhi-
110002, within 15 days of issue of this notice, so as to consider the matter
further. Lok 23(2\2f
(Dr.S.Eswara Reddy)
Drugs Controller General (India)