E-DRUG: Drug Regulatory Authority of Pakistan
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Colleagues
The Drug Regulatory Authority of Pakistan (DRAP) bill has been enacted by the Government of Pakistan on 12th November 2012. The bill had earlier been approved by the National Assembly and Senate after being moved by the Minister for National Regulation and Services. DRAP is envisaged as regulating the manufacturing, import, export, storage, distribution and sale of therapeutic goods in line with the Drugs Act 1976. For the first time in Pakistan Pharmacy services the role of Pharmacists are recognized.
Supporting countries to improve access to medicines is a core function of the World Health Organization (WHO). WHO provided intensified support to the pharmaceutical sector in Pakistan. Many missions were commissioned to review various aspects of the pharmaceutical regulations. The mission formulated and recommended the detailed framework that endeavors to strengthen the national medicines regulatory system. As of today no single product is either prequalified by WHO and by any stringent regulatory authority. Conversely the pharmaceutical manufacturers were advocated and technical guidance provided on prequalification program.
There was long awaited need to establish a National Medicine Regulatory Authority that implements internationally recognized standards in the regulations of pharmaceuticals. The tragic incidence in Lahore, where more than 160 cardiac patients died due to contaminated medicines, put more emphasis on the establishment of regulatory authority in Pakistan.
Under the Drug Act 1976, Pakistan was the first country in Asia to start GMP (Good Manufacturing Practices) but due to not having proper infrastructure and limited capacity [this was] not implemented in true spirit. There is a shortage of trained human resources across public and private sectors for pharmaceutical procurement, management and dispensation. Irrational use of medicines continues to increase the health care costs. As opposed to the WHO recommended ratio of 1:2,000 pharmacists per population, Pakistan has only 0.9 pharmacists per 100,000 population. This missing link in the health care system is yet to start its full role. But now it is hoped that new DRAP Act 2012 can be a tool to fill the gaps and the huge Pakistani Pharma sector can play role in improving access to quality and safe medicine at affordable cost. E-Druggers are requested to give their feedback and inputs for framing of stringent rules under this new Act.
Copy of DRAP ACT may be downloaded from http://ppapak.org.pk/drap2012\[1\]\.pdf
For feedback please email on below addresses:
Syed Khalid Saeed Bukhari (skhs77@gmail.com)
Waqas Ahmed (waqaspharmacist@gmail.com)
Alia Zafar (alia404@gmail.com)