On April 26, 2018, Department of Health and Family Welfare, Ministry of Health and Family Welfare, Government of India, vide its notification G.S.R. 411(E)1, issued directions regarding import, manufacture, sale and distribution of Oxytocin, to curb its misuse2. The government, in exercise of the powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 and in suppression of the notification number G.S.R. 29(E) dated January 17, 2014, declared that the drug Oxytocin shall be manufactured for sale, or for distribution, or sold in the manner specified below:

  1. The 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.
  2. The 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.
  3. The manufacturers of active pharmaceutical ingredient of Oxytocin shall supply the active pharmaceuti- cal ingredient only to the manufacturers in public sector, holding license under the Drugs and Cosmetics Rules, 1945, for manufacture of formulations of the said drug, for domestic use.
  4. The manufacturers of active pharmaceutical ingredient of Oxytocin shall supply the said active pharma- ceutical ingredient to the manufacturers in public and private sector, holding license under the Drugs and Cosmetics Rules, 1945, for manufacture of formulations of the said drug, for export purpose.
  5. The Oxytocin formulations manufactured by the public sector companies or undertakings licensed un- der the Drugs and Cosmetics Rules, 1945, for domestic use shall supply the formulations meant for hu- man and veterinary use only:
    • to the registered hospitals and clinics in public and private sector directly; or
    • 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.
  6. The Oxytocin in any form or name shall not be allowed to be sold through retail chemists.

Oxytocin is a neurotransmitter and peptide hormone which causes uterine contractions thereby, inducing labour naturally and controls post-delivery bleeding. But it is misused in the agriculture and dairy industry where cattle are injected with it, to make them release milk., After various measures to curb oxytocin misuse oOn April 20, 2018, the Health Ministry of India has released a gazette draft proposal for public/stockholder comment regarding labeling specification of Oxytocin formulation to facilitate product traceability which has been proposed to amend rule 96, in sub-rule (1) after clause (xii) of Drug and Cosmetic Rules, 1945, which reads3:

"(Xiii) (A). The manufacturers of drug formulations of oxytocin shall print the details specified below cking and tracing of their products, namely:

  1.                 Primary level packaging of two-dimensional barcode encoding unique and universal global product identification code in the 14 digits Global Trade Item Number format along with batch number, expiry date and a unique serial number of the primary pack;
  2.                 Secondary level packaging of one or two-dimensional barcode encoding unique and univer- sal global product identification code in the 14 digits Global Trade Item Number format along with batch number, expiry date and a unique serial number of the secondary pack;
  3.                  Tertiary level packaging of one dimensional barcode encoding unique and universal global product identification code in the 14 digits Global Trade Item Number format along with batch number, expiry date and a unique serial number of the Tertiary pack.

(B) The manufacturer of drug formulation shall maintain the data in the parent — child relationship for all three level of packaging and their movement in its supply chain.

(C) The data referred to in sub-rule (2) shall be uploaded on the central portal of the Central Govern- ment by the manufacturer or its designated agency before release of the drugs for sale or distribution.

(D) The responsibility of the correctness, completeness and ensuring timely upload of data on the Cen- tral portal shall be that of the manufacturer."

Note – The said draft rules will be taken into consideration on or after the expiry of a period of forty-five days from the date of publication via Gazette notification. Further, these rules shall come into effect after six months of the publication of the final rules in the Gazette of India.

Conclusion

The regulation over oxytocin manufacturing by public sector undertakings or companies only, barcodes labelling specification, sale and distribution to the registered hospitals and clinics are the major step taken by government to keep strict vigilance of oxytocin misuse at various level of its demand- supply chain. Moreover, the proposed concept of oxytocin supply chain data management on a central portal with manufacturers' support will ensure vement and delivery for the intended purpose only.

Footnotes

1 This notification shall come into force on the first day of July 2018.

2 http://www.egazette.nic.in/WriteReadData/2018/185017.pdf

3 http://www.egazette.nic.in/WriteReadData/2018/184866.pdf

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