Food and Pharmaceutical Law

The Food and Pharmaceutical team is equipped and possesses diverse experience in assisting clients with a wide range of issues. Working closely with the Regulatory and the Labour and Employment group, the lawyers give advise on the necessary regulatory issues relevant in the formation of food processing units including licensing, securing approvals under the labour laws for a manufacturing unit, packaging standards & norms, and several other aspects arising from various regulations related to the food sector such as Food Safety and Standards Act and corresponding Rules & Regulations, Legal Metrology Act and Rules and Bureau of Indian Standards.

In the pharmaceutical sector, our team has counseled clients in setting up manufacturing units in India for pharmaceutical companies and R&D units in Special Economic Zones. The experience also includes counseling in establishment, marketing authorization strategies, research & development, promotional practices, safety issues, health care, product classifications, pricing policy of drugs & devices, issues related to pharmacovigilence, taxation, labour and IP issues related to all classes of wellness industry, including alternative therapies, beauty, counseling, fitness and slimming, nutrition and rejuvenation. Together with the IP team, the lawyers also counsel clients on IP infringement of pharma products, dietary supplements, proprietary medicines, Drug and Cosmetics laws, Good Manufacturing Practice requirements and transactions involving the development, manufacture and commercialization of medicinal products (drugs or devices or any specialized product). The team has counseled and represented clients on diverse issues ranging from governing laws for drafting pricing policy for drugs and medical devices to laws on vaccination in India and legal requirements for pursuing medical internship programs by foreign medical students in Indian hospitals.

Our lawyers possess extensive knowledge on clinical trial regulations in India, representing drug manufacturers engaged in conducting clinical trials in India which is becoming a favorite destination for numerous global pharma companies. The lawyers have drafted, reviewed and negotiated several clinical trial contracts (both sponsor and investigator initiated), SOPs for numerous multi-national pharmaceutical companies. The experience also involves counseling clients on the prevailing clinical trial laws, as well as issues emanating under contract law, working with contract research organizations, and interfacing with the Ministry of Health and Welfare as well as the other regulators including the Drugs Controller General of India. The firm possesses the necessary pragmatic experience, skills and knowledge of good clinical practices (in Indian and other jurisdictions) and provides advise so that the clinical trials are conducted in accordance with the law, policy and best industry practices.