ISLAMABAD: The Drug Regulatory Authority of Pakistan (Drap) has decided to double its federal drug inspectors for more efficient market surveillance and to open the avenue to exporting medicines to Europe and the United States.

Drap CEO Dr Asim Rauf told Dawn the authority is “moving towards the World Health Organisation’s global benchmarking tool (GBT) III”, which would allow it to export medicines to a number of countries and help bridge the gap between Pakistan’s imports and exports.

The GBTs represent the primary means by which the WHO evaluates regulatory systems.

The methodoly enables it, and regulatory authorities, to identify strengths and areas for improvement, facilitate the formulation of an institutional development plan to build upon strengths and address the identified gaps, prioritise interventions and monitor progress and achievements.

Appointment of 25 more inspectors will be completed within three to four months, Drap CEO says

Dr Rauf said it has been decided to appoint 25 more federal drug inspectors, bringing the total number from 24 to 49 across the country.

“The appointment process will be completed within three to four months and foreign trainers will be called to train them. Initially, those inspectors will be deputed along with the already serving inspectors to learn or get experience, but later they will be allowed to work independently,” he said.

After this, he said, it will become possible to carry out international standard inspections and the advanced system would end differences between two separate inspections of one factory.

A statement issued by the Ministry of National Health Services said that Drap has taken concrete steps to strengthen its systems to ensure public access to safe and quality medicines.

“Public health promotion and protection is a priority and Drap has a significant role to play in betterment of healthcare system. It is adopting best practices to become a modern day regulatory body. In order to eradicate menace of spurious, smuggled and unregistered medicine from market and protect public, Drap has created 25 posts for FDIs to be posted throughout the country,” the ministry said.

It said that Drap has implemented the Integrated Regulatory Information Management System for online fee submissions, registration applications, renewal of registrations and post-registration variations. Pharmaceutical companies can submit the requisite information to Drap using this system, which aims to ensure transparency. Pharmaceutical companies were trained to use the submission system by Drap teams at workshops in Karachi, Lahore, Peshawar and Islamabad.

Pakistan has been importing $2 billion worth of medicines and earns just $200 million from medicine exports. Meanwhile, India has become the world’s third largest country in terms of volume of medicines.

According to the Indian Ministry of Chemical and Fertilisers’ Department of Pharmaceuticals, in 2009 India used to export $21.04bn worth of medicine, but has now reached $25bn in exports and is eyeing $50bn by 2050. The industry has a market share of $14bn in the US, where Pakistan does not export any medicine.

Published in Dawn, August 8th, 2019