Practice Areas

Drugs and Cosmetics Litigations

The Drugs and Cosmetics Act 1940 and Rules 1945 form a complete regulatory code governing the manufacture, storage, sale, and distribution of drugs, cosmetics, and related categories like Ayurvedic, Homeopathic, and medical devices, all of which Mace specializes in. Subsequent frameworks such as the Cosmetics Rules 2020, Medical Devices Rules 2017, and New Drugs and Clinical Trial Rules 2019 have reshaped compliance requirements for industry stakeholders. Litigation under this Act commonly arises in matters involving not-of-standard-quality drugs, spurious or adulterated products, misbranding, unlicensed manufacturing, licensing actions, FDCs, new drugs, medical devices, trademark and IP disputes, procedural lapses, inspector appointments, sanctions, enforcement powers, and various compliance obligations. Pharmaceutical companies frequently face disputes across this wide spectrum of regulatory, procedural, and enforcement issues.

Whether you require assistance with pharmaceutical litigation, pharma regulatory compliance, or directors' criminal liability related to the healthcare sector, Mace Corporate Associates offers the expertise and proven track record you need. Mace is one of the leading drugs and cosmetics lawyers in Delhi, and has the distinction of being a pharmaceutical lawyer, a legal expert specialising in Clinical Trials and Medical Device Regulations. Mace Corporate Associates is a top law firm with a rich history of providing expert legal services in New Delhi and across India. MACE is one of the few law firms that specialise in Pharmaceutical Laws.

Our firm has an unparalleled reputation for handling complex cases under a wide range of Healthcare Law and pharmaceutical regulations. Our team provides strategic legal counsel, advisory services, and robust litigation support for matters including, but not limited to:

• Drugs and Cosmetics Act
• Clinical Trial and Medical Devices Rules
• Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954
• NDPS Act
• Nutraceutical Regulations
• Clinical Establishments (Registration and Regulation) Act, 2010
• FSSA (Food Safety and Standards Act)
• Drugs Price Control Order, 2013

What truly sets us apart is our deep expertise, backed by a proprietary database of historical and current legislation, as well as an extensive database of judgments. These resources are critical to our consistent success in advising and representing clients in the pharmaceutical trade. With a presence in almost all major High Courts, including Bombay, Ahmedabad, Nagpur, Aurangabad, Bengaluru, Chennai, Kochi, Hyderabad, Amaravati, Delhi, Jaipur, Chandigarh, Shimla, Nainital, and Srinagar, we are well-equipped to handle litigation no matter where your case is located. Our local associates ensure seamless delivery and a commitment to the highest professional and ethical standards.

We have a proven track record as a pharmaceutical litigation lawyer for advice and regulatory compliance.