It turns out that the Drug Regulatory Authority of Pakistan (DRAP) is not equipped to perform its principal function of checking the quality of medicines, and hence is not recognised by the World Health Organisation (WHO).
The issue holds serious ramifications both for public health in this country and the drug manufacturing industry’s export potential.
A press report points out that DRAP was established back in 2012 for an effective enforcement of the Drugs Act 1976 to ensure both the quality and availability of medicines at affordable rates.
Yet more than two years on, the authority is yet to fulfil its basic functional requirements. In order to qualify for WHO approval, DRAP has to meet certain conditions.
All it needs to do is to hire sufficient staff to run its operations; and most importantly, to establish a credible drug testing laboratory to check medicines for their safety and effectiveness. According to the National Health Services Minister, Saira Afzal Tarar, DRAP has started recruiting people for 192 positions, but there is uncertainty about the laboratory despite a long-standing commitment to fulfil this vital requirement.
It was decided to set up Federal Drug Surveillance Laboratory (FDSL) back in 2006, and the completion schedule set for end 2007. A building was constructed for the purpose, only to be taken over by the Federal Medical and Dental College.
The equipment procured for the FDSL was shifted to another venue already in use of a different body with the result there is not much space left for the lab. Clearly, the concerned authorities do not have much interest in streamlining the affairs of the drug manufacturing industry.
That also comes out from the fact that following the enactment of the DRAP Act, 2012, it took the government a couple of years to appoint the authority’s first CEO. And the health minister seems helpless as she claims to have been making efforts, so far without success, to take possession of the laboratory building and prepare for the WHO recognition.
Because of the WHO’s missing seal of approval the export-oriented manufacturers remain at a disadvantage in the international market although they try and maintain quality standards. Those catering to domestic consumers include all sorts of elements, including those with lax quality control and outright fraudsters making fake medicines. Public health is exposed to avoidable risks.
During recent years, there have been two major scams involving substandard drugs which resulted in the loss of many lives. Notably, in both cases the drugs in question had to be sent abroad for testing. Had there been a fully functional and effective drug quality control system in place, a lot of human suffering and loss of life would have been averted.
It is about time the FDSL becomes operative in accord with internationally accepted standards. Nothing should be more important than ensuring those in need of medication get products that are up to the mark.