India is home to some of the world’s largest pharmaceutical companies and makes a significant contribution to the global output of drugs each year. India’s reputation as the pharmacy of the world has only grown in recent years. In the medical device sector as well, India is on its way to making a mark globally. The growth of the Indian pharmaceutical and medical device industry can be attributed in part to the well-established regulatory framework governing drugs and medical devices manufactured and marketed in India. Medicinal products have been regulated in India since the 1940s and the government has been making efforts in recent years to ensure the manner of regulating drugs and medical devices is in line with global standards. This has encouraged many foreign players to consider marketing their products in India as well as sourcing their products from India to meet the demand in other jurisdictions.

In this guide, Dr. Milind Antani, Darren Punnen and Shreya Shenolikar provide a comprehensive overview of the regulatory framework applicable to drugs and medical devices. The guide covers the entire supply chain from approval of drugs and medical devices to their sale to the end consumer. They have also provided information on the manner in which pharmaceutical adjacent products such as alternative medicinal products and nutraceuticals are regulated.

The complete article can be accessed here.

Reproduced from Practical Law with the permission of the publishers. For further information, visit practicallaw.com