The crucial Drugs & Cosmetics (Amendment) Bill 2015 which has been pending for long may be taken up during the Monsoon Session for passage since Prime Minister Narendra Modi has now appealed to medical device manufacturers to manufacture life saving devices to propagate India’s healthcare ecosystem as part of his “Make in India” campaign.
Medical devices form an extremely diverse product category, with over 14,000 different types ranging in complexity from wound dressings, adhesive bandages and syringes to pacemakers, prosthetics and MRI machines. However, despite being central to medical practice, they are lesser known to public and policymakers than pharmaceuticals.
The passage of Bill in the Parliament would be a big leap forward for healthcare delivery and allied sectors in India, and for the first time in India’s regulatory and legislative history, distinguishes medical devices from pharmaceuticals.
A draft National Medical Device Policy has also been put out to strengthen the initiative in the medical device sector. The government has opened up the sector, allowing foreign companies to invest in both brownfield and greenfield projects through the automatic route, distinguishing FDI policy for medical devices from that for pharmaceuticals.
Medical devices play a crucial role in diagnosing and managing diseases, particularly non-communicable diseases, by allowing people to live longer, healthier and more productive lives. The criticality of medical devices in dealing with India’s huge disease burden has often been overlooked, and worse, misunderstood.
“Our members are eager to respond to the Prime Minister’s ‘Make in India’ call and the Drugs & Cosmetics (Amendment) Bill 2015 will be vital in taking this to the last mile by establishing a clear, predictable and globally harmonised regulatory environment,” said Sanjay Banerjee, Chair of AdvaMed’s India Working Group which represents global medical devices manufacturing companies.
The changing demographics of India and lifestyle of its citizens has resulted in non-communicable diseases like diabetes and cancer becoming responsible for an increasing number of deaths and medical devices play a critical role in the treatment of non-communicable diseases. “The regulatory framework in our healthcare sector must adapt itself to this new reality and carve out a separate space for medical devices and stop treating them as simply drugs,” added Banerjee.
According to a recently released WHO report, non-communicable diseases accounted for an appalling 60 per percent of deaths in India in 2014.