WHO’s meet on medtech regulations at AMTZ brings SE Asian nations together

While the South-East Asian delegates mentioned of their dependency on import, almost at 100 percent, at the same time, the framework proposed by AMTZ could help access regulatory approvals


Visakhapatnam: Andhra Pradesh MedTech Zone (AMTZ), Vizag headed a pioneering meet up of World Health Organization (WHO) in the medical device and diagnostic domains as a part of the South-East Asian Regulatory Network (SEARN).

The day long program had attendees from delegates from seven South East Asian Regulatory bodies namely, Bhutan, Nepal, Bangladesh, Sri Lanka, Maldives, Thailand and Timor-Leste. WHO representatives from the India country office as well as the headquarters in Geneva also presented their perspectives. National Biological Institute and the Central Drug Standards Control General’s office were also part of the event. The key areas of discussion and deliberations were Regulation, Vigilance and Price Control.

Welcoming the representatives of various countries, Dr Jitendar Sharma, MD and 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 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.

While the South-East Asian delegates mentioned of their dependency on import, almost at 100 percent, the framework proposed by AMTZ can also help access regulatory approvals, which in turn can help access universal healthcare success.

Dr Poonam Malakondaiah expressed hope that these deliberations would lead to a better regulatory framework that wouldn’t stifle but augment the production of medical devices which would aid in tackling diseases at much faster pace.

Regulators from different countries have 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 are Mr.Md Razibul Habiib – Bangladesh, Mr Kinga Jamphel- Bhutan, Dr Ravikant Sharma- Deputy Drug Controller, Government of India , Mr Hashim Aboobakuru – Maldives, Mr Narayan Prasad Dhakal – Nepal  Mrs Upeksha Aponso – Srilanka, Mrs Sirinmas Katchamart- Thailand, Mr Delfim da Costa Xavier Ferreira-Timor-Leste

Dr Manisha Shridhar, regional adviser 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 understanding various standpoints 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 happiness in seeing an integrated medical devices ecosystem being developed in such a short time which includes Common Scientific Facilities, Regulatory Frame Work, Incubation Hub, Manufacturing besides creating a very hassle-free environment for the production of medical devices.

Dr Madhur Gupta in her closing remarks saw the future evolving out of AMTZ and KIHT and hoped that the medical devices would see a product category such as Bharat Products.

The participants enthusiastically took the tour of the zone and are definitely carrying back with them a lot to ponder over and implement in their respective countries.