Govt bans import of oxytocin, puts restrictions on domestic use

The Government of India has banned the import of the oxytocin and its formulations for human use and also to regulate and restricted the oxytocin formulations for human use. Its manufacture will also be stringently control and will be allowed only by public sector companies or undertakings licensed under the Drugs and Cosmetics Rules, 1945 for domestic use

Govt bans import of oxytocin, puts restrictions on domestic use
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What is Oxytocin?

Oxytocin or Pitocin is an injection used on pregnant women to induce labour. It is also used in animal husbandry, in bovine animals upon injecting the drug, the milk, which is otherwise stored in the udder of the cattle for its calves, is released, giving a few additional litres of milk.

Oxytocin is included in the Schedule H to the Drugs and Cosmetic Rules, 1945, requiring that the drug should be sold by retail under the prescription of a registered medical practitioner only

There have been some reports from time to time in various forums about misuse of oxytocin in the country by the farmers and dairy owners to extract milk from milch animals.

Central Drugs Standard Control Organisation and Ministry of Health and Family Welfare have taken various measures to prevent misuse of the drug.

notification

The notification from the Ministry of Health and Family Welfare stated:

The Central Government is satisfied that the use of the drug Oxytocin and its formulation in any name or manner is likely to involve certain risk to human beings and animals and that it is necessary and expedient to prohibit the import of the said drugs in the public interest.

Now, therefore, in exercise of the powers conferred by Section 10A of the Drugs and Cosmetics Act,1940 (23 of 1940), the Central Government hereby makes the following amendment in the notification of the Government of India in the Ministry of Health and Family Welfare No. G.S.R. 577(E), dated the 23rd July,1983, namely:

In the table below to the said notification, after serial number 11 and the entry relating thereto, the following serial number and entry shall be inserted, namely: Oxytocin and its formulation in any name or manner.”

Regarding the manufacture of oxytocin, the notification from Ministry of Health and Family Welfare stated:

The Drugs Technical Advisory Board constituted under section 5 of the Drugs and Cosmetics Act,1940 (23 of 1940) considered the said issue in its meeting held on the 12th February 2018 and recommended that oxytocin formulations for human use be regulated and restricted to be supplied only to registered hospitals and clinics in public and private sector to prevent misuse of the said drug;

And whereas, the Central Government, on the basis of the recommendations of the said Board and after examination of the matter, is satisfied that unregulated and illegal use of the drug oxytocin is likely to involve risk to human beings or animals and that in the public interest it is necessary and expedient to regulate and restrict the manufacture, sale and distribution of the drug oxytocin in the country to prevent its misuse by unauthorised persons or otherwise.

notifivation

Therefore, in exercise of the powers conferred by section 26A of the said Act, and in supersession of the notification number G.S.R. 29(E) dated 17th January, 2014, the Central Government hereby directs that the drug oxytocin shall be manufactured for sale or for distribution or sold in the manner specified below, namely:

  • 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.
  • 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.
  • The manufacturers of active pharmaceutical ingredient of oxytocin shall supply the active pharmaceutical ingredient 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.
  • 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.
  • 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, 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.
  • The oxytocin in any form or name shall not be allowed to be sold through retail chemist. This notification shall come into force on the first day of July 2018.