Fasken | Canada | 6 Mar 2024
On January 26, Health Canada issued a notice clarifying how a drug’s “dormant” status on the drug product database may affect whether that drug must…
Rouse | Global | 4 Mar 2024
Data exclusivity is generally understood to mean generic drug makers may not rely on data submitted by the originator to obtain approval for the same…
Arogya Legal | India | 6 Feb 2024
India’s central food regulatory authority, The Food Safety and Standards Authority of India (FSSAI), has approved an amendment to the existing…
Arogya Legal | India | 24 Jan 2024
In this article, we have discussed rounding-off principles that manufacturers and importers of drugs and medical devices should follow while…
Arogya Legal | India | 15 Jan 2024
Central Drugs Standards Control Organisation (CDSCO) has declared two Fixed Dose Combinations (FDCs) as rational. State Licensing Authorities can…
Arogya Legal | India | 12 Jan 2024
India’s small and medium-sized pharma manufacturers may not be able to comply with the new Good Manufacturing Practices which are going to come into…
Arogya Legal | India | 11 Jan 2024
India's Delhi High Court (DHC) has initiated a suo motu public interest litigation (PIL) against the repackaging or rebranding of expired food…
Arogya Legal | India | 10 Jan 2024
A two-judge bench of the Delhi High Court in India has upheld plant patent protection for the type of potato that was being used by major consumer…
Arogya Legal | India | 8 Jan 2024
The Government of India has notified the revised Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical…
Arogya Legal | India | 3 Jan 2024
The Export Inspection Agency under the Department of Commerce will henceforth issue health certificate to milk and milk product exporters only when…