Judicial Review of Drug Regulatory Authority Orders in Peshawar & Islamabad High Courts

The Drug Regulatory Authority of Pakistan (DRAP), established under the DRAP Act, 2012, is the central body responsible for regulating the manufacture, import, export, storage, and sale of therapeutic goods in Pakistan. While DRAP has broad regulatory powers, its decisions often have far-reaching commercial and legal consequences for pharmaceutical companies, distributors, and healthcare providers. When aggrieved parties find orders of DRAP or provincial drug authorities to be unlawful or excessive, they frequently turn to the High Courts of Islamabad and Peshawar by invoking constitutional jurisdiction for judicial review.

Legal Basis for Judicial Review

Judicial review of DRAP’s orders is grounded in Article 199 of the Constitution of Pakistan, which empowers High Courts to review actions of public bodies and authorities. Through this provision, the Islamabad High Court (IHC) and the Peshawar High Court (PHC) can examine whether DRAP or related authorities acted within their jurisdiction, complied with due process, respected fundamental rights, and adhered to the principles of natural justice.

Common Grounds of Challenge

Orders of DRAP are challenged before the High Courts on various grounds. These include lack of jurisdiction by the authority issuing the order, violation of procedural requirements, denial of fair hearing to the affected party, misinterpretation of the Drugs Act, 1976 or DRAP Act, 2012, and disproportionate penalties. Companies also approach the courts to contest cancellation or suspension of licenses, refusal of product registration, price fixation disputes, or confiscation of stock by drug inspectors.

Judicial Review in the Islamabad High Court

The Islamabad High Court has direct territorial jurisdiction over DRAP, as its headquarters is located in Islamabad. As a result, many significant cases involving licensing, product registration, and pharmaceutical pricing are filed before the IHC. The Court has repeatedly emphasized that while DRAP enjoys regulatory autonomy, its decisions must conform to law and cannot be arbitrary. Interim relief, such as stay orders against suspension of licenses, is often granted to ensure that businesses are not irreparably harmed before a final decision.

Judicial Review in the Peshawar High Court

The Peshawar High Court exercises jurisdiction over disputes arising within the province of Khyber Pakhtunkhwa. Pharmaceutical companies, distributors, and retailers operating in KP often challenge the actions of provincial drug inspectors and licensing authorities in PHC. While DRAP remains the central authority, PHC reviews cases where implementation of federal regulations intersects with provincial enforcement. The Court has played a vital role in ensuring that regulatory actions taken in KP are proportionate and legally justified, particularly in cases involving local manufacturers and distributors.

Remedies Available Through Judicial Review

When a High Court entertains a petition against DRAP’s orders, it may grant various remedies. These include setting aside unlawful orders, remanding matters back to the authority for fresh decision, directing DRAP to issue licenses or registrations, and declaring penalties imposed without due process as void. High Courts also provide interim relief by suspending regulatory actions until the petition is finally decided, which is crucial for pharmaceutical companies to maintain business continuity.