Ashwin Sapra

Practice Areas

Partner, Head Pharmaceuticals, Healthcare & Lifesciences

Ashwin heads the Firms Pharmaceuticals, Healthcare and Life Sciences practice. A subject matter specialist, he brings over 25 years of extensive domestic and international experience of advising clients on regulatory, transactional, IP and litigation issues in the pharmaceutical, medical devices and healthcare sector. He routinely advises the Firms international and domestic clients on complex regulatory issues relating to the approval, import, sale/ marketing/ distribution of drugs, cosmetics, nutraceuticals, medical devices and diagnostic kits/ equipment’s in India. Ashwin also advises key clients on regulatory and liability issues pertaining to recall/ withdrawal of drugs and medical devices.

Relevant Experience:

Healthcare and Regulatory Compliance:

• Advising on regulatory issues pertaining to development, approval, manufacture, and marketing of drugs, cosmetics and medical devices in India. Ashwin routinely advises clients on regulatory, ethical, product liability and compliance issues pertaining to clinical trials in India and further advises clients on government and industry anti-kickback statutes and issues related to drug promotion in terms of physician-patient and drug representative- physician interactions. He regularly engages in review and analysis of regulatory approvals and registration licenses of target companies as part of business incorporation and due diligence efforts in large scale business merger/ acquisition matters. Ashwin also advises bio-tech companies on regulatory requirements that govern access and use of domestic biological resources.

Intellectual Property:

• Advising clients in the pharmaceutical and bio-technology/ life sciences sector on IP portfolio protection strategy, management, prosecution, enforcement and litigation. Apart from deep rooted experience in supervising freedom-to-operate searches for domestic and foreign clients. He has extensive experience in conducting IP portfolio audits for clients and providing guidance on the setting up of in-house standard operating procedures pertaining to IP asset protection and has previously been involved in creating IP concept presentations to educate client employees on IP issues.

Professional Memberships

Bar Council of Delhi and Delhi High Court Bar Association