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Drap to begin benchmarking pharmaceutical units tomorrow

ISLAMABAD: The Drug Regulatory Authority of Pakistan (Drap) has begun benchmarking the country’s pharmaceutical units to check if they are following current good manufacturing practices (CGMP).

The new initiative will start tomorrow (Monday).

It aims to bring the authority at par with international standards and pave the way for the export of medicines from Pakistan.

“We were working on this for a long time, and called international trainers to train 25 drug inspectors in Pakistan. Two training sessions were held in Islamabad and London and after that the inspectors also sat exams to make sure they would perform well in the field,” Drap CEO Dr Asim Rauf told Dawn.

The exercise aims to bring the authority at par with international standards and pave the way for export of drugs

When asked how the CGMP work, Dr Rauf said that after the inspections are complete, companies will be divided into categories according to the new criteria.

He said the companies that are classified in lower categories will need frequent visits and could be closed.

“As there will be less attention on the topmost companies, we will be able to focus more on companies with issues or deficiencies and will either address their issues or close them,” he said.

According to a statement issued on Saturday, Drap has taken new initiatives to further ensure the quality and safety of therapeutic goods in the country.

“The authority has issued a comprehensive plan for assessment of CGMP compliance of manufacturers of drugs which is due to start from 10th of this month. All the pharmaceutical manufacturers in the country will be assessed on latest quality risk management approach through a pool of proficient team of auditors who have been extensively trained to evaluate CGMP compliance level.

“This practice is pre-requisite for Pakistan’s membership of Pharmaceutical Inspection Cooperation Scheme (PIC/S) and would help in World Health Organisation accreditation of Drap. One of the benefits of such a program is enhanced exports of pharmaceuticals as the local industry will be uplifted through international practices,” a spokesperson said in the statement.

In response to questions, it was informed that Drap would direct inspectors to monitor stocks of protective equipment against the novel coronavirus throughout the country. The statement said this measure was taken to ensure such equipment is available for use in the country.

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