The registration process in India is about to take a positive change, with the proposal to regulate medical devices and drugs separately. According to AdvaMed, the Indian medical device industry is predicted to be be a US $30 billion in the next 10 years with adequate guidance policy and support. Sanjay Banerji of AdvaMed India said, “The healthcare industry will grow to US $30 billion with proper policies and appropriate regulatory guidance in India. The new draft of the Drugs and Cosmetics Bill, 2015 will provide answers to several challenges the healthcare industry face. Presently, medical devices in India is regulated the same as drugs under the Drugs and Cosmetics Act (Notified Medical Devices in India).”
As one of the Emerging markets, the Indian healthcare industry is likely to grow fast as the statistics show overseas manufacturer interest in the market. Banerji further said: “It may be complicated as they were totally different and should be regulated differently. The new amendment bill will allow classifying medical devices based on risks, separate regulation for medical devices, clinical trials which would make registration of medical devices in India stringent and straight forward (Documents required for Medical Device Registration in India). AdvaMed also recommended reducing the duty for life saving medical devices.
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