Clasis Law

Tuesday, 22 August 2017

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Healthcare Regulatory and Compliance Affairs

Healthcare Regulatory and Compliance Affairs

The Firm is well equipped to cater to its clients in the Pharmaceutical, Healthcare, Medical Devices and Lifesciences industry. Our members have extensive experience in advising clients in the healthcare sector in connection with their proposed investments in India as well as regulatory issues pertaining to the research and development, manufacture, marketing and import of drugs, cosmetics and medical devices. The Firm also routinely advises clients on regulatory, ethical and compliance issues pertaining to clinical trials in India.  

Apart from regular advisory and transactional ability, the Firm also specializes in regulator areas including obtaining the requisite registrations/ approvals and maintaining compliance thereafter. Members of this highly specialized practice have worked on a diverse nature of applications for registrations/ approvals including manufacturing site and product registrations, new product approvals, change notifications, re-registrations of manufacturing site and product, import license for Indian agents/ importers/ subsidiaries of foreign manufacturers etc.

In addition, our industry experts advise clients on government and industry anti-kickback statutes and guidelines relating to physician-patient and drug representative- physician interactions. Our members have advised clients on anti-bribery and anti-corruption issues arising out of Indian (The Prevention of Corruption Act, The Prevention of Money Laundering Act), US (The Foreign Corrupt Practices Act) and UK (Bribery Act) legislations governing ethical business practices in the pharmaceutical and healthcare sector.

The Firm actively monitors legislative and policy developments at a national and state level and advises clients on specific actions needed to address potential threats with respect to new regulations and formation of risk mitigation strategies having legal, ethical, policy and risk management considerations.