Countries of the South-East Asia Region Launch Path-breaking Initiative to Guarantee High-Quality Medical Products

SEAR/PR/1643

25/11/2016, New Delhi, India, – In a move to guarantee access to high-quality medical products that can protect, diagnose and treat illness and disease in the WHO South-East Asia Region Member countries today launched a path-breaking initiative that will enhance information sharing, collaboration and convergence of regulatory practices across the Region.

“Access to high-quality medical products is a matter of life and death for everyone. The coming together of the Region’s regulatory agencies marks a watershed moment that will ensure medical products produced and sold in the Region do exactly what they are supposed to. This will benefit the vulnerable in particular, who are often pushed into poverty when paying for low-quality or unsafe products. It will also enhance our ability to effectively tackle health security threats such as antimicrobial resistance and tuberculosis, which are exacerbated by ineffective drugs that breed resistance,” Dr Poonam Khetrapal Singh, Regional Director for WHO South-East Asia said.

The presence of poor quality medical products on the market is the result of limited regulatory capacity to enforce best practices needed to develop, produce and distribute them. While many regulatory authorities in the Region lack sufficient technical capacity, staff and resources to perform effectively, even well-resourced authorities are hard-pressed to thoroughly evaluate all new products and enforce existing regulations. The new South-East Asia Regulatory Network (SEARN) aims to change that.

“The network, which connects every one of the Region’s national regulatory authorities, will help harmonize existing regulations and streamline work-sharing arrangements in order to get the most out of our collective strengths,” Dr Boonchai Somboonsok, Secretary General of Thailand’s Food and Drug Administration said. “By collaborating and working together we can learn from one another while effectively regulating the vast number of products available in our countries.”

For the Region’s smaller countries – such as Bhutan and Maldives – SEARN will significantly expand the ability for national regulators to ensure medical products are safe and of adequate quality.

“Greater information sharing, collaboration and alignment of regulatory standards in the Region will be of great use to Bhutan. As a smaller country it is important for us to work with national regulators in other countries and have rapid access to regulatory information about products we import to Bhutan to ensure their quality and safety. We’re immensely pleased to be a part of this initiative and look forward to its implementation,” Sonam Dorji, the former head of Bhutan’s Drug Regulatory Authority said.

At the same time as protecting consumers, SEARN will have a substantial impact on how the medical product market’s supply side functions. “As a major producer of medical products India is very much looking forward to SEARN’s full implementation of planned activities. By working together to increase regulatory capacity SEARN will ensure that only products that are of a high standard can get to the markets we are supplying. SEARN will also help to improve convergence towards good regulatory practices in the Region,” Dr G N Singh, the Drugs Controller General of India, Central Drugs Standard Control Organization, said.

Dr Khetrapal Singh further emphasized how the new initiative would accelerate progress towards achieving the Sustainable Development Goals via the attainment of universal health coverage. “By ensuring medical products are of a high quality we will expand health coverage and ensure every member of society can get the care they need,” Dr Khetrapal Singh said. “SEARN will strengthen health systems across South-East Asia and help fulfill each person’s right to the highest attainable standard of health.”

SEARN was established as an outcome of regional meetings in 2015 and 2016. It exists on a voluntary basis and will meet annually in addition to carrying out ongoing joint activities.

The WHO South-East Asia Region is comprised of 11 countries, all of whom are now SEARN members. These countries are Bangladesh, Bhutan, Democratic People’s Republic of Korea, India, Indonesia, Maldives, Myanmar, Nepal, Sri Lanka, Thailand and Timor-Leste.

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Shamila Sharma
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