India is one of the largest medical device markets in Asia. This market is expected to grow at 15% a year for the foreseeable future. A growing middle class has led the government to allocate the equivalent of 5% of annual GDP to expand and improve health care in the country. Despite this, it is expected that the greatest demand for medical devices will come from private hospitals and clinics. Currently, 75% of India’s medical device market consists of imports. This webinar will discuss the nuts and bolts of importing medical devices into India, including tax consequences. Panelists will also cover joint ventures for the manufacture of medical devices in India for both the domestic and export market, clinical investigations and quality standards. Topics will include India’s Drugs and Cosmetics Act and Rules, and their implementation by the Central Drugs Standard Control Organization (CDSCO) as the key medical device regulatory organization in India. Specific attention will be given to structuring transactions, the regulatory framework, as well as proposals for creating a comprehensive framework and single regulatory body specifically for medical devices.
Moderator: Bhalinder L. Rikhye, Peltz & Walker, New York
Amy Hariani, Director and Legal Counsel for the U.S.-India Business Council (USIBC), Washington, D.C. Ms. Hariani manages the Life Sciences and Legal and Professional Services portfolios.
Rohan Shah, Managing Partner Economic Laws Practice (ELP), Mumbai. Mr Shah is well known for his expertise on advisory, policy and controversial issues related to domestic and international taxation in India.
Third speaker to be announced
There will be a 15 minute question and answer period
ABA Section of International Law
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