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Bombay High Court Quashes Criminal Complaint in Drugs and Cosmetics Act Case Due to Violation of Statutory Right Under Section 25(4) — Delay in Filing Complaint After Expiry of Shelf Life Deprives Accused of Right to Get Sample Tested from Central Drugs Laboratory.

The petitioners, a pharmaceutical company and its directors/employees, were accused in a criminal complaint filed by the Drug Inspector under the Drug...

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High Court of Karnataka Quashes Criminal Proceedings Against Drug Manufacturer in NSQ Case Due to Prejudicial Delay in Testing. Delay of 20 Months in Analysis of Drug Sample Violated Right to Challenge Government Analyst's Report Under Section 25(3) of Drugs and Cosmetics Act, 1940.

The criminal petition under Section 482 of the Code of Criminal Procedure, 1973, was filed by M/s Zim Laboratories Ltd. and its officers (the manufact...

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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...