ISLAMABAD: The Drug Regulatory Authority of Pakistan (Drap) has decided to introduce new technology post-marketing surveillance that will allow it to test drugs in pharmacies and stores on the spot.

Sessions to train federal and provincial authority officials to use these mini-laboratory devices have begun and discern whether the medicines were out of specification due to human error or because ingredients were intentionally decreased.

Many patients also complain that locally produced medicines are ineffective compared to imported ones.

Drap Additional Director Asim Rauf told Dawn that post-marketing surveillance is carried out to ensure medicines reach consumers with efficacy and quality.

“The quality assurance mechanism is triggered as soon as the product reaches the market. Currently, a team of experts from the United Kingdom and United States have been training Drap staff on risk-based sampling and how to identify target areas,” he said.

He said the teams not only check unregistered and spurious medicines, they also check registered medicines to see if their specifications are the same as those claimed at the time of registration.

“During checking we will be able to identify the out-of-specification products because of variation in temperature, human error or deliberately. During the five-day training participants have been trained to use five devices that are part of the mini-lab and identify other factors,” he said.

According to an official statement, the training is being conducted in collaboration with the World Health Organisation and the United States Pharmacopoeia.

Drap CEO Dr Sheikh Akhter Hussain has said the authority was following its mission within the medicine regulatory network to protect public health by detective defective medicinal products on the market.

“This is not limited to pharmaceuticals but it has expanded this program to alternative medicines, health and [over the counter] products and medical devices. Adoption of a risk based approach to market surveillance would allow Drap to concentrate its resources on those areas considered most likely to pose a risk of quality defects. To achieve this mission Drap has constituted various committees,” he said.

Published in Dawn, June 20th, 2018

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