CDSCO notifies import of Oxytocin Reference Standards

The Union health ministry has notified import of oxytocin reference standards exclusively for test and analysis through a gazette notification dated January 27, 2020.

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CDSCO

CDSCO Notifies Import Of Oxytocin Reference Standards Exclusively For Test And Analysis

The Union health ministry has notified import of oxytocin reference standards exclusively for test and analysis through a gazette notification dated January 27, 2020.

To download the notification, Click here

As per the Central Government notification, import of oxytocin reference standards is necessary exclusively for the purpose of examination, test or analysis before carrying out commercial manufacturing of the drug.

Import of oxytocin reference standards exclusively for test and analysis has been done in exercise of the powers conferred by section 10A of the Drugs and Cosmetics (D&C) Act, 1940 (23 of 1940).

The notification further states, “The Central Government makes the following amendment in the notification of the Government of India in the Ministry of Health and Family Welfare dated July 23, 1983.

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In the said notification, in the Table, for serial number 12 and the entry relating thereto, the following serial number and entry shall be inserted – “12 oxytocin and its formulation in any name or manner except oxytocin reference standards imported exclusively for the purpose of test and analysis.”

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).

Central Government had prohibited the import of oxytocin in public interest by amending notification dated the 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.

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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.

Government had earlier banned manufacture and sale of oxytocin by private manufacturers and restricted manufacturing rights to only one public sector undertaking (PSU) named Karnataka Antibiotics and Pharmaceuticals Ltd (KAPL).

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