PID

PR No. 205 DRAP WILL ESTABLISH NATIONAL PHARMACOVIGILANCE CENTRE IN ISLAMABAD; PLOCY BOARD OF DRAP GRANTED THE APPROVAL OF PHARMACOVIGILANCE REGULATIONS, 2017, Islamabad: October 24, 2017

Spokes person of DRAP 22nd meeting of the Policy Board of DRAP was held on 23rd October, 2017 under the chairmanship of Federal Secretary NHS,R&C. The meeting was attended by the provincial Secretaries of health or their representatives from government of Punjab, Sindh, KPK, Baluchistan and FATA, as well as by expert members of the Board.

Policy Board in addition to routine functions granted the approval of Pharmaco vigilance Regulations, 2017 as recommended by the Authority.

Under these regulations a National Pharmaco vigilance centre 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 National Pharmaco vigilance centre. In addition to pharmaceutical companies, medical professional’s doctors, Pharmacists, Nurses will also submit pharmaco vigilance 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 organization and 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 Vigilance Cell in DRAP.

The annual price increase for 2017-2018, based on Consumer Price Index (CPI) of 4.16% 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.

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