Central Drugs Standard Control Organisation

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A Closer Look at India’s Pet Care Sector and Regulatory Grey Areas

In Part I of this series, titled ‘The (Pawsome) Pet Care Sector: Through a Legal Lens’, we provided a broad overview of the registration and compliance requirements for entities in the pet care industry. We also discussed factors like the entry options, the sector’s migration to the online mode, and relevant judicial pronouncements.

The legal framework for pet care in India is spread across a host of rules and legislations. The relevant regulatory duties are also divided between various regulators including the Food and Safety Standards Authority of India (“FSSAI”), the Central Drugs Standard Control Organisation (“CDSCO”), and the Animal Welfare Board of India, among others. Therefore, industry players will have to keep track of a wide range of legislations (along with relevant State rules and municipal laws) to ensure proper compliance.Continue Reading Barking up the Right Tree: A Closer Look at India’s Pet Care Sector and Regulatory Grey Areas

New Drugs and Clinical Trials Rules, 2019 – A Regulatory Overview India 

Issues around payment of compensation in cases of clinical trial related injury, disability and death have long remained open. Despite a directive from the Hon’ble Apex Court, much was left open to question. On March 19 of this year, the Ministry of Health and Family Welfare (MoHFW) eventually took steps in this regard and notified the New Drugs and Clinical Trials Rules, 2019 (NDCT Rules) under the aegis of the Drugs and Cosmetics Act, 1940 (D&C Act), thus bringing an end to a long-drawn-out process to codify the rules applicable to clinical trials.
Continue Reading New Drugs and Clinical Trials Rules, 2019 – A Regulatory Overview