The market for medical electronics in India is worth USD 1 Billion Dollars and is expected to is expected to grow by five times in the next three years. The Pharmaceutical sector alone is worth USD 36.7 billion dollars. The Drugs and Cosmetics Act, 1940; India’s principal legislation governing this industry, prescribes a stringent regulatory framework that is often uncertain in its application to emerging technologies. Seen in the context of India’s emphasis on universal health care; businesses often have to grapple with an unclear statutory compliance regime in addition to difficulties around IP protection and enforcement.
Lawyers at Factum Law not only have strong fundamentals in the Drugs and Cosmetics Act, 1940; but have served on ethics committees which review clinical trials of new drugs. Combined with our expertise in the jurisprudence governing data privacy and telemedicine; we are uniquely suited to assist clients in this sector in complying with the law, preparing to meet changing context and scenarios imposed by the mandate for universal healthcare defined in the constitution and achieving protection for their Intellectual property.