Draft paper on national policy for the medical devices- reduce imports from 80% to 30% in next 10 years.

 

The department of pharmaceuticals (DoP) has released a draft paper on national policy for the medical devices, inviting feedback and remarks of the industry and stakeholders, till the 25 March. The efforts of the government is to reduce import dependence from 80% to below 30% in next 10 years and ensure self-reliance quotient of 80% in Med-Tech by ensuring Make in India with SMART milestones.The report envisaged that by 2047, 

1. India will be one amongst Top 5 Global manufacturing hubs in terms of value and technology for Medical Devices. 
2. India will be home to 25 MedTech $Bn companies and home & originator to 25 high end futuristic technologies in MedTech. 
3. India will emerge as Champion in critical components, cancer diagnostics, medical imaging, ultrasonic scans, molecular imaging, & PCR technologies .India will achieve 10-12% of Global Market Share of Medical Devices Sector to arrive at a $100-300 Bn industry.
4. India will have about 50 Medical Devices Clusters across India for faster clinical testing of Medical Devices to boost product development and innovation.

The Government has allowed 100% foreign direct investments (FDI) in medical devices sector while prescribing that domestically sourced components must contribute to 25-50 per cent of the cost of medical devices to qualify for public tenders and also has notified 135 in-vitro diagnostic medical devices and 19 medical devices where there is sufficient local capacity and local competition available in the country.

Recognizing the need for higher levels of investments for the creation of testing and laboratory facilities, the sub-scheme “Assistance to Medical Device Industry for Common Facility Centre” has been revised and renamed as “Promotion of Medical Device Parks” which has been approved by the Government of India on 20th March 2020. The parks will provide common testing and laboratory facilities/centre at one place reducing the manufacturing cost significantly and will help in creating a robust ecosystem for medical device manufacturing in the country. The total financial outlay of the scheme is ₹ 400 crore and the maximum assistance under the scheme for one Medical Device Park would be limited to ₹ 100 crore. The model is Andhra Pradesh MedTech Zone, India’s first exclusive medical device manufacturing park result of MoU signed between the state government and Association of Indian Medical Devices Industry (AiMeD), the Foundation Stone of the 270-acre exclusive manufacturing park was laid on August 19, 2016 at Nadupur village of Pedda Gantyada Mandal in Vishakhapatnam by Andhra Pradesh Chief Minister Mr Chandrababu Naidu.