Alerts & Updates 29th Aug 2018

Medical Devices, Pharma & Life Sciences – Court Update

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By a Notification dated 27.04.2018 bearing no. G.S.R No. 411 (E) dated 27.04.2018, the Central Government, in exercise of powers under Section 26 A of the Drugs & Cosmetics Act, 1940, prohibited private sector companies from manufacturing for sale in India, importing and selling Oxytocin in India w.e.f. 01.07.2018 and by subsequent notification dated 29.06.2018 bearing no. G.S.R 602(E), extended such date to 01.09.2018.

Oxytocin is an essential medicine listed in the National List of Essential Medicines, 2015 and as such a “Scheduled Formulation” under the Drugs (Prices Control) Order, 2013.

Attached is our short update on the facts leading to such prohibition and the pending challenge before the Delhi High Court. The Central Government’s action will be tested against the guidelines laid down by the Hon’ble Supreme Court in Union of India vs Pfizer Ltd. (2018) 2 SCC 39 (the FDC case) regarding the manner in which action under Section 26 A is to be taken.

Hope you find the attached update useful. We look forward to your comments, views and insights.

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