Singh & Singh has extensive experience and expertise in providing legal advice on a range of regulatory and associated issues in the pharmaceutical, healthcare and life sciences industries. The Firm regularly works with leading domestic and multinational pharmaceutical, cosmetic, and life sciences companies, providing them with advisory and litigation services to navigate the complex regulatory landscape in India and ensuring compliance with laws and regulations.
The Firm offers its services at each stage of the regulatory framework including development, manufacturing, sale, distribution and marketing of drugs, medical devices, cosmetics etc. This includes inter alia obtaining permission/ licenses for conducting clinical trials, obtaining manufacturing and marketing approvals from the Regulatory Authorities, import/export permissions, drug licensing, facilitating representations and presentations before Government/ Regulatory Bodies such as Drugs Controller General of India (DCGI), National Pharmaceutical Pricing Authority (NPPA), and Ministry of Chemicals & Fertilisers, Department of Pharmaceuticals.
Landmark Cases
Some landmark cases where the Firm was involved:
Roche Products (India) Pvt. Ltd v. Zydus Lifesciences Ltd. & Ors.
Singh & Singh represented Reliance Life Sciences
This case addresses critical issues relating to approval and marketing of biosimilar drugs.
Union Of India vs Pfizer Ltd.
AIR 2018 SCC 265Singh & Singh represented Pfizer Ltd.
The Hon'ble Supreme Court held that prior consultation with the DTAB was not mandatory for the Central Government to exercise its powers under Section 26A of the Drugs & Cosmetics Act.
F-Hoffman La Roche Ltd. & Ors. v Drugs Controller General of India & Ors.
Singh & Singh represented Hetero Healthcare Ltd.
The case is before the Delhi High Court for biosimilar versions of Trastuzumab.