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Supreme Court Refers to Three-Judge Bench the Question Whether Quantity of Mixture or Pure Drug Content Determines Punishment Under NDPS Act. The Court Held That E. Micheal Raj Requires Reconsideration as It Omitted Note 2 of Notification and the Scheme of the Act Treating Preparations as a Whole.

The Supreme Court, in a reference arising from multiple appeals and writ petitions, considered the correctness of the decision in E. Micheal Raj v. In...

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Supreme Court Sets Aside Division Bench Order Allowing Biosimilar Launch Without Biosimilarity Claim — Remands to High Court for Fresh Consideration of Interim Relief in Drug Regulatory Dispute

The Supreme Court of India heard an appeal against an interim order of the Delhi High Court Division Bench dated 18.09.2019. The dispute involved M/s ...

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Supreme Court Upholds Quashing of Notification Restricting Oxytocin Manufacture to Public Sector. Notification under Section 26A of Drugs and Cosmetics Act, 1940 held invalid for being arbitrary and disproportionate to the objective of curbing misuse.

The case involves a challenge to a notification issued by the Ministry of Health and Family Welfare under Section 26A of the Drugs and Cosmetics Act, ...

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Bombay High Court Dismisses Bayer's Challenge to Compulsory License for Nexavar Under Section 84 of Patents Act, 1970. Court Holds That Patentee's Import of Drug at High Price Does Not Satisfy Reasonable Requirements of Public or Constitute Working of Invention in India.

The petitioner, Bayer Corporation, a US-based pharmaceutical company, held a patent for the drug Sorafenib Tosylate, sold under the brand name Nexavar...