On the recommendation of India’s Drugs Technical Advisory Board, the government has agreed to delink the medical devices sector from the pharmaceutical sector according to a report in The Times of India.
India’s Central Drugs Standards Control Organization will post the revised schedule on its Website, and will issue a legal notification regarding the change to the drug rules, the newspaper reported. Additionally, the new regulations require efficacy and safety testing to ensure that products made in India are produced according to internationally recognized standards.
India’s medtech industry is expected to surge forward. Becton, Dickinson & Co., CEO Vincent Forlenza told Livemint that he expects the Indian medtech market to grow more than 10% in the next five years due to growth in private sector investment in India’s hospital infrastructure, an expansion in the insurance marketplace, and India’s growing middle class. Siemens too has made sizable investments in medical device manufacturing facilities in the country. However, India still imports 70% of its medical devices. Economic Times reports that the U.S.‒India Business Council expects India’s medtech industry to grow from its current $4.4 billion in sales to $7 billion by 2016.
Having a separate body to regulate the medtech industry would “expedite the ongoing creation of research and development and product innovation that medical device companies offer India, leading to faster growth of medical device manufacturing in the country,” Maulik Nanavaty, senior vice president and president for neuromodulation at Boston Scientific, told Economic Times in July.
