Litigation and Consulting

Introduction to drugs and cosmetics cases allied laws

The Drugs and Cosmetics Act of 1940 and Rules of 1945, which regulate the manufacturing and sale of drugs and cosmetics, are at the core of Mace's expertise. The Act contains comprehensive provisions for regulating the manufacture, storage, sale and distribution, stock, and offer for sale of drugs and cosmetics. The Act further provides for Ayurvedic preparations, Homeopathy medicines, and Medical devices, all of which Mace is well-versed in.

The Act is a complete Code in itself. It provides detailed procedures and statutory compliances for the prosecuting agencies and imposes obligations on the aggrieved persons to comply diligently with specific requirements. The operating procedures are found in the Rules of 1945. The elaborate rules for various kinds of drugs, cosmetics, and blood banks set the procedures to be adopted by the drug authorities.

With the introduction of the Cosmetics Rules, 2020, provisions from the Drugs and Cosmetics Rules 1945 were deleted, and new sets of rules called Cosmetics Rules, 2020, were created. There has been a significant change in the regulation of medical devices. The ‘Medical Devices Rules,2017’ are now being implemented, which manufacturers of medical devices are required to comply with. These changes are crucial for all stakeholders in the industry to be aware of. For new drugs, separate rules have been framed, i.e. New Drugs and Clinical Trial Rules, 2019 and put into force.

Prosecution for Not Standard Quality (NSQ) drugs, New Drugs and Fixed Dose Combination (FDC), License Suspension and Cancellation, Trademark, Patent and Copyright disputes, etc., are significant areas that found their way to litigation in the Court of law.

The following disputes are witnessed by pharmaceutical companies under the D&C Act 1940: