ISLAMABAD: The Drug Regulatory Authority of Pakistan (Drap) has finally started moving towards an organised system which will help it get World Health Organisation (WHO)’s listed authorities (WLA) permission to export medicines.

The authority on Tuesday inaugurated the Pakistan Integrated Regulatory Information Management System (PIRIMS) to switch to a paperless working environment.

The system integrates licensing, registration, inspection and pharmaco-vigilance activities besides providing a platform to the pharmaceutical industry for submission of applications, regulatory correspondence and feedback/complaint mechanism to address problems faced by the applicants.

Drap’s Chief Executive Officer (CEO) Dr Asim Rauf told Dawn that an organised automated system had been introduced in the authority.

“Even steps taken by officers would be documented and recorded to know what kind of changes are made on files and for how long a file stayed at each desk. The record would be saved for good. Moreover, performance of the staff would be evaluated on the basis of the record,” he said.

Replying to a question, he said earlier Pakistan was trying to get Level III Accreditation but recently WHO changed it into WLA which is a bit more advanced and close to level IV accreditation.

“It was demand of the WHO to introduce PIRIMS which is a requirement for WLA. Now we would move to get WLA accreditation which would allow us to export medicines to a number of countries. Currently, only developed countries of European Union, America and Asia have the WLA. Even countries like China, India and Turkey lack such an accreditation,” Dr Rauf said.

According to an official statement, a meeting was held on Tuesday with Special Assistant to Prime Minister on Health Dr Zafar Mirza in the chair for development and introduction of the automated system of data integration for drugs and their manufacturers.

Dr Mirza stressed the need for strict compliance to the essentials of good governance i.e. accountability, transparency, efficiency and stakeholders’ engagement.

“This is the finest example of the use of modern technology by using information management systems to ensure transparency. PIRIMS’ deployment will streamline the requirements, procedures and assessment by Drap’s officers in order to ensure that timelines are followed in a conspicuous manner.”

The Drap CEO added that PIRIMS would help attain status of the WHO-listed authority which requires clarity and transparency in every function.

According to the statement, “On this software, Drap’s officers would be able to transparently view, assess and process various matters related to registration of drugs, licensing of pharmaceutical units and inspection activities. The procedures on the software follow strict protocols to ensure timelines of standard operating procedures.”

Published in Dawn, December 18th, 2019