On September 22, 2017, The Central Drug Standard Control Organization (CDSCO) has notified to all the state drug controllers regarding strict regulatory control over manufacture, sale and distribution of Oxytocin and to curb its misuse. The CDSCO has received the letter from Ministry of Health and Family Welfare vide F.No. BD/VET/CELL/13.2014 (Pt-1) dated 09-05-2017 that the following measures are to be taken in order to comply the direction of the Hon'ble High court, Himachal Pradesh on the subject cited above-

I. Constitution of special task force in each District, of each State, to ensure that no prohibited/ regulated drug including Oxytocin is freely available in each district in open market, save and except in manner prescribed.

II. Concerned Drug Controllers of the States where licenses of manufacturing of Oxytocin have been issued shall examine the license of all existing manufacturers of Oxytocin to ensure that the same have been issued strictly in accordance to the Drugs and Cosmetics Act, 1940 and Rules 1945 and that the manufacturers mandatorily comply with all the conditions of the Act and rules framed there under. Immediate appropriate actions as per the statutory provisions may be taken wherever violations of the rules are found.

III. The State Drug Controllers shall place on their respective websites, by 10th of each month, details of licenses issued to various manufacturers along with the monthly statement of production and sales of Oxytocin with complete particulars and details furnished by manufacturers. The manufacturer of Oxytocin shall in turn submit these details beforehand, so as to reach the office of drug Controller by 7th of every month.

IV. The wholesaler and retailers of all prohibited scheduled drugs including Oxytocin shall maintain records, as required under law and the same shall be produced for inspection after every quarter before the officer specifically deployed for this purpose by the drug controller. V. You may take appropriate steps of undertaking IEC activities for sensitizing public about ill effects of Oxytocin both on humans and the animals specially mulching cattle, and about penal provisions for abuse/misuse of Oxytocin27.

About Oxytocin

Oxytocin, a neuro-hormone that also acts as neurotransmitter in brain, is naturally released in large amounts by the posterior pituitary gland in mammals. Oxytocin is known to induce contractions of the uterus during labour and stimulate ejection of milk during breastfeeding. It also promotes the maternal nurturing behavior along with general psychological stability in women as per various researches. Synthetic Oxytocin is being widely administered in obstetric practice for induction of labour, control of bleeding following delivery, and for the stimulation of milk letdown reflex in human and cattle as well. However, along the way people started using Oxytocin injections unsystematically on milch animals not only during delivery of a calf, but more frequently to get benefit/profit out of that for example – a milch cattle injected 5 ml of Oxytocin twice a day just five minutes before of milking, so that milk flows fast out of the udder28.

There have been many complaints regarding misuse of Oxytocin injection in milch cattle to increase milk production by dairy owner and also to increase the size of vegetables and fruits by farmers in the country.

However, there no scientific data in support of such practices is available. The National Dairy Research Institute (NDRI) and Indian Council of Agricultural Research (ICAR) has informed that there is no scientific evidence that artificial use of Oxytocin has adversely affected progeny of cattle and buffaloes resulting in dwindling of livestock. However, continuous Oxytocin use could lead to a progressive addiction and lack of response to normal let down of milk29.

Regulation of manufacture , sale and distribution of Oxytocin in recent years

The Government of India, Ministry of Health and Family Welfare, issued a notification under Section 26A of the Drugs and Cosmetics Act, 1940 vide G.S.R. 29(E) dated January 17, 2014 restricting the manufacture and sale of Oxytocin as under:

  • The manufacturers of bulk Oxytocin drug shall supply the active pharmaceutical drug only to the manufacturers licensed under the Drugs and Cosmetics Rules, 1945 for manufacture of formulations of the said drug.
  • The formulations meant for veterinary use shall be sold to the veterinary hospitals only30.

Further, the Department of Animal Husbandry, Dairying and Fisheries have also issued an Advisory to all the State Governments to comply with the provisions of the above-mentioned notification. Despite this, the continued misuse of Oxytocin injection in the country has been considered by the Drug Consultative Meeting (DCC) as well as Drug Technical Advisory Board (DTAB) in its various meetings.

In the 69th meeting of DTAB, the board opposed against Oxytocin prohibition, as it has definite use for therapeutic purposes. The problem of misuse of Oxytocin is more related to stricter control over the manufacture and sale of the drug especially through clandestine channels.31

Similarly, the 49th DCC meeting also raised the following recommendations to fight against the misuse of Oxytocin in the country:

  • State Drug Regulatory officials must conduct raids with the assistance of Police Authorities at the suspected outlets of such drugs near the dairy farms after due surveillance to apprehend culprits red-handed.
  • The manufacture and sale of Oxytocin formulations by the licensed manufacturers in the State should be monitored regularly.
  • States should share information about the raids conducted and results of investigations with other concerned State Drug Control Authorities and Zonal offices for interstate coordination.
  • Samples of milk may be drawn to assess the presence of Oxytocin in milk.
  • Rapid test for detection of Oxytocin may be developed.
  • The Port offices of CDSCO shall inform custom authorities that import of all peptide formulations be monitored for their use.
  • The Central Government may request Police authorities of States to take cognizance of offences related to misuse of Oxytocin.
  • FSSAI may be asked to explore the possibility of declaring the use of Oxytocin on animals for production of milk as an offence under the FSSAI Act.
  • Each State and Central regulatory system must develop an intelligence wing for keeping close watch, sharing of information and prompt action for checking/eradicating the misuse of Oxytocin in the country32.

Conclusion:

The manufacture, sale and distribution of Oxytocin is well described under the provisions of the Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945. However, a strict vigilance and regular monitoring/ inspection of Oxytocin misuse by Central and State drug authorities are recommended.

Footnotes

27 http://www.cdsco.nic.in/writereaddata/notice22_9_2017. pdf

28 http://www.bwcindia.org/Web/Awareness/LearnAbout/ Oxytocin.html

29 http://dahd.nic.in/sites/default/files/LS%20328.pdf

30 http://cdsco.nic.in/writereaddata/G.S.R.%2029%20(E).pdf

31 http://www.cdsco.nic.in/writereaddata/70th%20DTAB%20 minutes.pdf

32 http://www.cdsco.nic.in/writereaddata/Minutes%20of%20 %20DCC%20dated%2016_10_2015%20.pdf

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