First independent drug testing lab in country

Islamabad:Export of medicines from Pakistan is set to register a boost in the days ahead, with the World Health Organisation (WHO) pre-qualifying first independent drug testing laboratory in the country.

Located in the federal capital, the state-of-the art laboratory has been found by the WHO to operating at an acceptable level of compliance of its Good Practices for Pharmaceutical Quality Control Laboratories (GPPQCL).

Most modern equipment has been imported from Germany and Japan for the laboratory which is using United State’s Federal Drug Authority (FDA) compliant software, to make sure that the drugs tested by it meet the international standards.

Over the past three years, the top markets for Pakistan have not varied much. Afghanistan, Sri Lanka, Philippines, Vietnam, Lithuania and South Sudan have been the biggest markets for Pakistani pharmaceuticals.

However, market share of Pakistani medicines in Afghanistan has been on the downward trend for the past three years, falling to $65 million in 2018 from $75 million in 2016 due to loss of market share to India. Similarly, market share in Vietnam declined to 0.4 percent in 2018 from 1.0 percent in 2016 due to increasing presence of Indian products.

The market in the Western world had remained unexplored due to their stringent compliance requirements, but the establishment of a WHO accredited independent drug quality control lab will remove this hurdle enabling hundreds of pharmaceutical companies to have an access to the markets in USA and Europe.

Talking to a select group of reporters here Dr Ambreen Amir, Chief Operating Officer, Prime Health private ltd said there were around 700 pharmaceutical companies in Pakistan and the country had an enormous potential for export of generic medicines.

She said the establishment of an independent laboratory meeting the international standards would help pharma industry find new destinations, which it could not access in the past due to stringent compliance requirements of the regulations in US, Europe and other developed countries.

About the capacity of the WHO pre-qualified lab, she said it can perform comprehensive analysis from credible prediction of in vivo disintegration and dissolution profile of a tablet to testing for any impurities and determination of a medicine’s shelf life under specific temperature and humidity.