Islamabad - Drug Regularity Authority of Pakistan (DRAP) on Tuesday decided to establish a national database centre to collect the data of adverse drug reactions, an official said.

The decision of establishing ‘National Pharmacovigilance’ Centre here was taken at the policy board meeting of the DRAP.

The spokesperson DRAP Sajid Shah said that the approval was given as per the Drug Regulations 2017.

Under the regulations, a National Pharmacovigilance Centre will be established to collect data on adverse drugs reactions. The centre will also monitor and keep the surveillance of marketed drugs as per international practices to ensure the safety of patients.

The official said that registration holders of medicines will be responsible to submit data of Adverse drugs reactions from their products to National Pharmacovigilance Centre.

Along with registration holders, pharmaceutical companies, medical professional’s doctors, Pharmacists, Nurses will also submit pharmacovigilance data.

The official also said that a new portal will be available for patients and public to report a drug complaint or adverse report.

The meeting was held under the chairmanship of Secretary National Health Services & Regulations Coordination (NHSRC) and was attended by the provincial Secretaries of health or their representatives from the government of Punjab, Sindh, KP, Baluchistan and FATA, as well as by expert members of the board.

The official added that provincial centres will also be established and 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 (WHO) and thus medical professionals of Pakistan will have access to the updated information on drugs.

The board also approved the draft guideline for a code for the pharmaceutical industry for ethical marketing and interaction with a 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 per cent as announced by Statistical Bureau of Pakistan, the increase in schedule drug of around 2.08 per cent and 2.91 per cent for non-schedule drugs category in accordance with 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 with the policy.