The Union health ministry is planning to amend the Director General of Foreign Trade (DGFT) notification for allowing import of oxytocin API to manufacture formulations in the country for export purpose only.
Oxytocin is an essential life-saving drug used widely for women during childbirth for the induction and augmentation of labour to make childbirth safe and prevent death resulting from postpartum haemorrhage (PPH).
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As of today, import of DMF grade API of Oxytocin is not possible since it has been kept in prohibited list by the DGFT through a notification dated April 24, 2018.
Industry representation has also been made to recommend DGFT to shift oxytocin API from prohibited list to restricted list.
As per the DGFT notification, the import of oxytocin and its formulation in any name or manner has been prohibited in India in exercise of the powers conferred under Section 10A of the Drugs and Cosmetics (D&C) Act, 1940.
However, import of oxytocin reference standard for the purpose of test and analysis has been exempted through a notification dated January 27, 2020.
Drugs Technical Advisory Board (DTAB) was also apprised that Sun Pharmaceutical Industries Limited, in its representation dated September 15, 2020 stated that it is developing oxytocin formulation for export to the regulated market like the USA and requires DMF grade of oxytocin API.
DTAB deliberated the matter and recommended to amend the notification for allowing import of oxytocin API to manufacture formulations only for export purpose.
Further, the chairman DTAB Sunil Kumar also stated that he will give an opportunity to Indian pharmaceutical manufacturers to export such drugs to various countries and also facilitate Atmanirbhar Bharat.
The Central government had prohibited import of oxytocin in public interest by amending notification dated July 23, 1983 through a notification dated April 24, 2018 as its use and its formulation in any name or manner may involve certain risk to human beings and animals.
Subsequent to issuance of the said notification dated April 24, 2018 for prohibition of import of drug oxytocin and its formulation in any name or manner, the Central government received representations from various stakeholders to allow import of oxytocin reference standards for the purpose of examination, test or analysis.
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