Burning issues related to medical device & diagnostics deliberated at AMTZ-SEARN meet

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Issues related to regulatory approvals, access to universal healthcare, regulation, vigilance and price control were deliberated during a recent Andhra Pradesh Med Tech Zone (AMTZ) hosted workshop at Vizag on medical device and diagnostics.

The workshop was organised in collaboration with World Health Organisation (WHO) which witnessed participation of delegates from seven of the South-East Asian Regulatory Network (SEARN) nations namely Bhutan, Nepal, Bangladesh, Sri Lanka, Maldives, Thailand and Timor-Leste.

SEARN delegates shared their concern on huge dependency on imports, almost at 100%, where a framework proposed by AMTZ can help ease regulatory approvals and hence achieve accessible universal healthcare.

Besides the National Institute of Biologicals (NIB) and the Central Drug Standards Control Organisation (CDSCO) officials, WHO representatives from the India country office as well as headquarters in Geneva also presented their perspectives.

Speaking on the sidelines of the conference, Dr Jitendar Sharma, CEO, AMTZ elucidated the role AMTZ has played in the regulatory framework in India. He spoke about the WHO guidelines for pre-qualification in in-vitro diagnostics (IVDs) that are being adapted at AMTZ along with vaccines in drugs thus enabling manufacturers of medical devices on pan India to access UN markets. He also offered to be of help to all the countries with the repository of experience that AMTZ and its group of institutions have in the field of medical technology.

Dr. Poonam Malakondaiah, Special Chief Secretary, Health, Government of India expressed hope that these deliberations would lead to a better regulatory framework that wouldn’t stifle but augment the production of medical devices thus giving boost in tackling diseases at much faster pace.

Regulators from different countries shared the regulatory frame work in their respective countries and the issues that they are facing as far as medical devices are concerned. The regulators who participated were Md Razibul Habiib – Bangladesh, Kinga Jamphel, Bhutan, Dr Ravikant Sharma, deputy drug controller (DDC), Government of India, Hashim Aboobakuru, Maldives, Narayan Prasad Dhakal, Nepal, Upeksha Aponso, Srilanka, Sirinmas Katchamart, Thailand, Delfim da Costa Xavier Ferreira, Timor-Leste

Dr Manisha Shridhar, regional advisor, WHO Regional Office for South-East Asia (SEARO), New Delhi appreciated the viewpoints of representatives from all the countries and assured that this working group will find solutions that could be helpful in achieving public health goals of various countries.

She underlined the fact that different countries are at different stages as far as regulation of medical devices is concerned and and addressing them would lead to a better regulatory framework across the board.

Dr Madhur Gupta, WHO, India office underlined the need for standardization of medical device regulatory framework and assist smaller countries in building the regulatory capacity. She also took the participants through the work done by WHO towards achieving this goal.

The representatives from all the countries expressed optimism in seeing an integrated medical devices eco- system at AMTZ being developed in such a short time which includes common scientific facilities, regulatory frame work, incubation hub and manufacturing besides creating a conducive environment for the production of medical devices.

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