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AMTZ releases report on medical device mfg in India in collaboration with WHO, DIPP, DoP

Shardul Nautiyal, Mumbai
Thursday, February 16, 2017, 08:00 Hrs  [IST]

Andhra Pradesh MedTech Zone (AMTZ) in collaboration with Department of Pharmaceuticals (DoP), Department of Industrial Policy and Promotion (DIPP) and World Health Organization (WHO) has released a report titled “Medical Device Manufacturing in India: A Sunrise”.

AMTZ is India's first government funded medical devices manufacturing park at Visakhapatnam in Andhra Pradesh. The foundation stone of India’s first exclusive medical device manufacturing park was laid on August 19, 2016 at Nadupur village of Pedda Gantyada Mandal in Vishakhapatnam by Andhra Pradesh chief minister Chandrababu Naidu.

The major aim of this report is to analyse the current situation and provide suggestions for the future developments in the medical device manufacturing area. The report emphasizes the need for collective measures from the government, industry and research community which will lead to reduction in healthcare costs across the country.

The report gives a low down on global and Indian medical device market highlighting global and Indian medical device market size, segments, growth factors for high demand in India, existing and proposed device clusters in the country, high import trend in Indian scenario and high potential manufacturing segments in India.

Other areas touched upon include improving regulatory landscape for medical devices in India. It focuses on the changes brought about in the regulatory scenario to boost the medical device manufacturing in India. The various initiatives include Materiovigilance Programme of India, Schedule M-III, mandatorily significant experience for manufacturing supervisor, Drugs & Cosmetic (Amendment) Bill, 2015, Draft National Medical Device Policy, 2015, Make in India initiative, establishment of medical device parks and medical device testing labs, corrections in the inverted duty structure, voluntary scheme for certification of medical devices – ICMED, WHO global model regulatory framework for medical devices including IVDs, July 2016.

The report also talks about situational analysis of core medical devices manufacturing sector. A situational analysis of medical devices core manufacturing sector (non-import) based on the survey conducted by AiMeD, PHD Chambers of Commerce and Industry and the World Association for Small and Medium Enterprises (WASME) is presented in the report.

The key findings in the report towards following actionable dimensions for the medical device industry are registration and certification, R&D and Intellectual Property, investments and turnover, human resources and skills and product range.

The report was released at India Medical Device Conference-2017 jointly organized by the DoP, DIPP and Federation of Indian Chambers of Commerce & Industry (FICCI) recently. India Medical Device Conference 2017 is one of the largest exhibition and conference for the Indian Pharmaceutical market.

Session was attended by Union Minister for Chemicals and Fertilizers Ananth Kumar, Chief Minister of Karnataka Siddharamaiah, Minister of State for Chemicals and Fertilizers Mansukh L Mandaviya, Nirmala Sitharaman, Minister of State for Commerce & Industry, Dr. Henk Bekedam, WHO Representative to India and officials from the government, industry and trade associations.

The swift work and progress done in a matter of 6 months from the time of inception of AMTZ was applauded by the audience and everybody present at the event.

AMTZ has already announced bookings of factories at a refundable fee of Rs.6,250; Rs.12,500 & Rs.25,000 for a 0.25 acre; 0.50 acre and 1.00 acre manufacturing unit respectively. AMTZ has been receiving bookings continuously since the launch of booking on 2nd October.

AMTZ would include facilities such as component testing centre, electro-magnetic interference laboratory, medical grade low vacuum molding, cabinet molding, injection molding centres, 3D designing and printing for medical grade products, sterilization and toxicity testing centre, radiation testing centre, gamma irradiation facility, rapid prototyping centre, warehousing and regulator’s office.

 

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