ISLAMABAD: The Drug Regulatory Authority of Pakistan (Drap), responsible for monitoring the quality of medicines in the country, is not recognised by the World Health Organisation (WHO) and resultantly Pakistani companies are unable to export to developed countries.
A major hurdle in the recognition of the Drap is that the Federal Drug Surveillance Laboratory (FDSL), a credible drug testing laboratory which is mandatory for recognition, could not be made functional. While the building for the laboratory was constructed and the required equipment was purchased, a medical college was established in the building.
National Health Services (NHS) Minister Saira Afzal Tarar claimed that she has been making efforts to take possession of the laboratory building, located in Chak Shahzad and following the establishment of the laboratory, the Drap will be recognised by the WHO.
The Drap was established under the Drap Act 2012 for effective coordination and enforcement of the Drugs Act 1976. The authority is responsible for ensuring the quality of drugs all over the country; moreover it is mandated to ensure the availability of medicines at affordable rates.
Pakistani companies unable to export medicines to developed countries
An NHS ministry official, requesting anonymity, said that two years after its establishment the Drap is yet to be recognised by the WHO because it does not fulfill the basic requirements.
“Two basic requirements, having sufficient staff in all departments and an international standard laboratory, are still unfulfilled,” he said.
The official said “To fulfill the requirement of a complete staff, the Drap has started recruitment for 192 posts. However, the laboratory remains a big hurdle without which the Drap cannot be recognised by the WHO.”
He further said that a laboratory is essential to ensure that new medicines are safe and effective. “A credible drug testing laboratory is the most important requirement for quality control,” he said.
The ministry official pointed out that unless the Drap is recognised, medicines produced in Pakistan cannot be exported. “In 2013, medicine exports were at US $200 million a year and in 2014, exports had fallen to US $167 which is reflective of the lack of interest in importing medicines from Pakistan. Currently, Pakistan exports medicines to some developing countries such as Jordan,” he said.
The proposal for the FDSL was approved on May 13, 2006 by Central Development Working Party (CDWP) and the cost of the project was Rs156.27 million. The completion date for the project was set for the end of 2007.
However, once the building for the laboratory was constructed, it was decided in 2011 to establish the Federal Medical and Dental College (FMDC) in the laboratory building.
Another ministry official, requesting anonymity, told Dawn that the equipment for the FDSL was shifted to the National Control Laboratory (NCL), in Chak Shahzad but there is a lack of space at the laboratory.
The official explained that the purpose of establishing this laboratory was to ensure the availability of quality medicines which would be certified by a credible testing system accredited the WHO.
NHS Minister Saira Afzal Tarar told Dawn that recognition of the Drap by the WHO is a very serious issue because it is affecting the country’s medicine exports.
“I raised the issue on Wednesday, during a meeting chaired by President Pakistan Mamnoon Hussain at the presidency and informed the participants that unless we take possession of the FDSL building, the Drap will not be recognized by the WHO,” she said.
“In the meeting, in which secretary cabinet and representatives of FMDC also participated, it was decided that the college will be shifted to the F-9 Park and the laboratory will be established in the building,” she said.
The minister said that once the building is acquired, the Drap would be approved by the WHO within three to four months. “After this, Pakistan will be able to export its medicines to developed countries,” he said.
NHS Secretary Ayub Sheikh said that he has been making efforts to resolve the issue and ensure that Drap is recognised by the WHO.
Published in Dawn, July 10th, 2015