WHO suggests reforms in pharmaceutical sector
ISLAMABAD: The World Health Organisation (WHO), after a report on governance in the public pharmaceutical sector of Pakistan, has found registration of medicines, inspection and market control of manufacturers and distribution, clinical trials and procurement and distribution of medicines vulnerable to corruption.
The report, ‘Measuring transparency to improve good governance in the public pharmaceutical sector in Pakistan’ said that data about registered medicines was available in the form of notifications circulated after the meetings of the Registration Board. Inspection and market control of manufacturers and distributors was also found to be vulnerable to corruption. No written guidelines exist with regard to inspection activities. There are no written procedures to prevent regulatory capture and no external auditing of inspections is carried out by another country. However, the Drug Regulatory Authority of Pakistan (Drap) and the provincial Quality Control Board have unwritten procedures.
Clinical trials of medicines have been rated vulnerable to corruption. Clinical trials of medicines in Pakistan are regulated under the Drug Research Rules 1978, amended in 2013. There is no written policy or procedure for submission of a clinical trial application to the Independent Ethics Committee.
Published in Dawn, November 9th, 2017