Drug Regulatory Authority of Pakistan

The Drug Regulatory Authority of Pakistan (DRAP) is a self-governing entity under the Federal Government of Pakistan. It functions under the administrative supervision of the Ministry of National Health Services, Regulations & Coordination. DRAP was formed in accordance with the DRAP Act 2012 and is tasked with ensuring effective coordination and implementation of The Drugs Act, 1976.

Role and responsibilities
DRAP is committed to ensuring that all drugs, medical devices, cosmetics, alternative medicines, and health products meet a certain standard of quality and are safe and effective for use. It is responsible for making sure that therapeutic goods, which are approved and available in the market, comply with the prescribed standards of quality, safety, and efficacy. The regulatory tasks carried out by DRAP encompass registration and marketing authorization, vigilance, market surveillance and control, licensing establishments, regulatory inspection, laboratory testing, clinical trials oversight, pharmacovigilance, and lot release of biologicals.

Response to the shortage of medicines
In response to the shortage of life-saving medicines across the country, DRAP has taken several initiatives:

DRAP has set the maximum retail prices for 25 life-saving drugs and 25 newly introduced medicines in an effort to make these essential drugs more affordable for the public.

A committee was formed to propose strategies to alleviate the scarcity of life-saving medicines and liaise with pharmaceutical manufacturers and importers.

DRAP App
In an effort to eradicate black market practices and put an end to hoarding, DRAP introduced a mobile application. This app provides real-time and evidence-based information about drug shortages in the market.

Importing Indian drugs
There is no restriction on hospitals or individuals on importing vital medicines from India for their own use under the Import Policy Order 2022 after obtaining a No Objection Certificate (NOC) from DRAP.

Crackdown on spurious medicines
DRAP decided to launch a crackdown against spurious medicines to eradicate the menace of unregistered, spurious and sub-standard medicine.

Controversies
Allegations have been made against Asim Rauf the CEO of DRAP for operating a Benami pharmaceutical company, which is perceived as a clear instance of conflict of interest.