ISLAMABAD: During the first 11 months of last year, Drug Regulatory Authority of Pakistan carried out over 50,000 inspections and raids to stamp out the business of spurious and substandard drugs.
The raids were conducted on the direction of National Task Force (NTF) on Eradication of Spurious and Substandard Drugs.
The NTF, headed by Special Assistant to Prime Minister on Health Dr Zafar Mirza, was established to get the World Health Organisation’s Listed Authorities (WLA) permission to export medicines across the globe.
“A team of World Health Organisation also visited Pakistan a month ago and expressed satisfaction over the efforts of Drap for manufacturing of quality drugs and eradication of substandard ones,” Drap Chief Executive Officer (CEO) Dr Asim Rauf told Dawn.
According to the report of the NTF, from January to November 2019, Drap carried out overall 51,194 inspections and detected 7,135 violations of Drap Act 2012.
The move was aimed at getting WHO’s listed authorities permission to export medicines
Document shows that 587 cases of unregistered drugs sale were registered, 1,710 cases of sale of drugs without warranty / false warranty, 1,895 cases of sale of drugs without drug sale licence, 830 cases of sale of drugs without qualified person and 390 cases of sale of expired drugs were registered.
It shows that 222 cases of sale of misbranded drugs, 11 cases of sale of counterfeit drugs, 513 cases of unsatisfactory storage conditions, 778 cases of sale of controlled drugs without sale purchase records, 119 cases of sale of drugs labelled ‘Not for Sale’ and 80 cases of illegal advertisement were registered.
Another document shows that in November 2019 as many as 54 sites were inspected in Islamabad, 10 cases were registered over sale of drugs without qualified persons, four cases were registered over unsatisfactory storage conditions, two cases of sale of unregistered drugs and one case of sale of counterfeit drugs was registered.
At 20 places seizure of stock was ordered and sampling was done for test/analysis at 2 sites.
Dr Rauf, who is also member of the NTF, said there was general perception about Pakistan that here spurious, substandard and nonregistered medicines were sold.
“We took all provinces onboard and it was decided that strict action would be taken to address the issue. A number of persons were arrested after registration FIRs,” he said.
While replying to a question, he said cases were sent to the Drug Court. In some cases, suspects moved High Courts to get their facilities desealed or against the actions taken by NTF.
“It is part of steps to get the WLA, which will allow us to export the medicines in a number of developed countries. WHO team had visited Pakistan and did audit for one week due to which we are hoping the things would further improve in near future,” Dr Rauf claimed.
Drap has already launched the Pakistan Integrated Regulatory Information Management System (PIRIMS) for switching towards a paperless working environment. The automated management system integrates licensing, registration, inspections and pharmacovigilance activities and provides a platform to pharmaceutical industry for submission of applications, regulatory correspondence and feedback/complaint mechanism to address problems faced by the applicants.
It was another requirement to get WLA.
Replying to another question, Dr Rauf said earlier Pakistan was trying to get Level III Accreditation of WHO but recently WHO has changed it into WLA which is a bit more advanced and close to level IV accreditation of WHO.
“WLA accreditation would allow us to export medicines to a number of countries. Currently only developed countries of European Union, America and Asia have WLA. Even countries like China, India and Turkey lack WLA accreditation,” he said.
Published in Dawn, January 2nd, 2020