ISLAMABAD: Pakistan needs to move towards an automated system to inspect medicines and factories in order to become a member of the Pharmaceutical Inspection Cooperation Scheme (PICS) and avoid inspections of Pakistani medicines in 49 countries, a representative from United States Pharmacopeia said on Wednesday.
A USP team has been training 25 officials from the Drug Regulatory Authority of Pakistan (Drap) on good manufacturing practices, to build capacity and strengthen the inspection system.
Speaking to Dawn, USP representative Khalid Saeed Bukhari said that in a manual system, every inspector has a different approach to inspecting companies and factories, because of which, if two inspectors are sent to the same factory they will submit contradictory reports.
“The only option is to switch over to the automated system due to which there will be a checklist for everything and similar reports will be generated despite who inspects the factory. Moreover, because of automated system, it will become possible that all the things would be checked without any delay,” he said.
He said an automated system would make it possible to check if a company’s medicine had previously been rejected.
“Sometimes companies apply for medicines that have already been rejected, with different names. So all the departments should be working together and should have access to check how many products from a company have failed in the past.
“It is simple; if a company’s product has been failed, how can it manufacture a similar product under another name,” he asked.
According to an official statement issued on Wednesday, Mr Bukhari said everyone high expectations from the Drap officers to transform the working of the organisation and achieve World Health Organisation Level III functioning an PICS membership.
“By achieving level-III of National Regulatory Authority, Drap would be considered a performing regulatory authority by the WHO and by achieving PICS membership, foreign inspections from 49 countries would be exempted and Drap’s inspection would be considered reliable,” he said.
Published in Dawn, May 10th, 2018
Dear visitor, the comments section is undergoing an overhaul and will return soon.