ISLAMABAD: The Drug Regulatory Authority of Pakistan (DRAP) will establish a national vigilance center in Islamabad.
A decision in this regard was taken during a meeting of the DRAP Policy Board.
The board meeting also granted the approval to the Pharmacovigilance Regulations, 2017.
The 22nd meeting of the Policy Board of DRAP was held under the chairmanship of NHSRC federal secretary.
The meeting was attended by the provincial secretaries of health or their representatives from the governments of Punjab, Sindh, KPK, Baluchistan and FATA, as well as by expert members of the board.
The Policy Board, in addition to routine functions, granted approval to the Pharmacovigilance Regulations, 2017 as recommended by the authority. Under these regulations, a national pharmacovigilance center will be establish to collect data of adverse drugs reactions, as a continuous monitoring and vigilance of marketed drugs, in line with international practices, for patient safety.
Registration holders of medicines will submit data of adverse drugs reactions from their products to the national pharmacovigilance centre. In addition to pharmaceutical companies, medical professional’s doctors, pharmacists, nurses will also submit pharmacovigilance data.
Furthermore, a new portal will be available for patients/public to report a drug complaint or adverse report.
Provincial chapters will also be established and will be linked for monitoring and early detection of any potential drug-related adverse event.
This centre will also be linked with Uppsala monitoring centre of World Health Organisation. Thus, medical professionals of Pakistan will have access to the updated information on drugs.
The board approved in principle the draft guideline for code for pharmaceutical industry for ethical marketing and interaction with healthcare professional.
DRAP will share these drafts with stakeholders before final notification. In addition, for consistent improvements towards international practices and strengthening of DRAP, a quality management cell was approved along with a vigilance cell.
The annual price increase for 2017-2018, based on Consumer Price Index (CPI) of 4.16 percent as announced by Statistical Bureau of Pakistan, the increase in schedule drug of around 2.08% and 2.91% for non-schedule drugs category in accordance to the Drug Pricing Policy, 2015, that was approved by the ECC. The DPC has recommended the subject annual price increase as per Drug Pricing Policy 2015. The board was informed its implementation in accordance to the Policy.