India: CDSCO Notice Regarding Strict Regulatory Control Over Manufacture, Sale And Distribution Of Oxytocin And To Curb Its Misuse

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.


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.


27 pdf

28 Oxytocin.html



31 minutes.pdf

32 %20DCC%20dated%2016_10_2015%20.pdf

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on

Click to Login as an existing user or Register so you can print this article.

Similar Articles
Relevancy Powered by MondaqAI
In association with
Related Topics
Similar Articles
Relevancy Powered by MondaqAI
Related Articles
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Mondaq Free Registration
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
Mondaq News Alert (some suggested topics and region)
Select Topics
Registration (please scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of

To Use you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.


The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.


Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions