Govt Allows Import Of Oxytocin Reference Standards For Test & Analysis


Mumbai : The Central government has allowed import of oxytocin reference standards for test and analysis after submission of test license issued by the Drugs Controller General of India (DCGI).

According to a notification issued by Directorate General of Foreign Trade (DGFT) on May 23, 2022, import of oxytocin reference standards is allowed exclusively for test and analysis subject to submission of test license issued by DCGI/CDSCO for items such as hormones, prostaglandins, thromboxanes and leukotrienes, natural or reproduced by synthesis; derivatives and structural analogues thereof, including chain modified polypeptides, used primarily as hormones, polypeptide hormones, protein hormones and glycoprotein hormones, their derivatives and structural analogues.

The items also cover steroidal hormones, their derivatives and structural analogues, catecholamine hormones, their derivatives and structural analogues and medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale.

This came after a request from the drug industry. The Union government received several representations from industry representatives seeking permission for import of drug reference standards for the purpose of test and analysis.

However, import of oxytocin shall remain prohibited.

The government in April 2018 imposed a ban on import of oxytocin and its formulations to prevent its misuse by dairy owners and farmers to increase milk production and raise the size of vegetables. It also restricted the manufacture of oxytocin formulations for domestic use to the public sector only.

However, the government in October 2021 exempted import of active pharmaceutical ingredient (API) of peptide hormone oxytocin for the purpose of manufacturing formulations exclusively for exports.

Oxytocin is a natural hormone that stimulates uterine contractions in childbirth and lactation after childbirth. Oxytocin is also used to reduce bleeding after childbirth. It may also be used along with other medications or procedures to end a pregnancy. Oxytocin is in a class of medications called oxytocic hormones.

In March 2018, the central government indicated to regulate and restrict oxytocin for human use so that the drug is supplied only to registered hospitals and clinics in the public and private sector to prevent its misuse.

The Drugs Technical Advisory Board (DTAB) in its 78th meeting held on February 12, 2018 had also agreed to prohibit the import of oxytocin and its formulations for human use as well as animal use under Section 10 of the Drugs and Cosmetics Act, 1940.

Acting on DTAB’s recommendation, the government has allowed only public sector undertakings to manufacture oxytocin formulations for domestic use with an aim to regulate its production.

09 dt 23-05-22 Eng-250522080525


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