How to Challenge DRAP Licensing Decisions in Pakistan – Procedure Explained - Nouman Muhib Kakakhel

How to Challenge DRAP Licensing Decisions in Pakistan – Procedure Explained

Licensing decisions by the Drug Regulatory Authority of Pakistan (DRAP), including refusals, suspensions, cancellations, or revocations of drug registrations, manufacturing licenses, import permits, or medical device enlistments, can significantly impact pharmaceutical businesses and public health access. Established under the Drug Regulatory Authority of Pakistan Act, 2012 (DRAP Act), DRAP ensures therapeutic goods meet safety, quality, and efficacy standards, but its decisions are subject to administrative and judicial review to uphold fairness and due process. Challenges typically begin with an internal appeal to DRAP’s Registration Board or relevant division, followed by recourse to the Appellate Board under the Drugs Act, 1976, and potentially higher courts. This procedure is governed by the DRAP Act, Drugs (Licensing, Registering and Advertising) Rules, 1976, and Drugs (Appellate Board) Rules, 1976, emphasizing evidence-based submissions and timelines. For expert navigation of these processes, Nouman Muhib Kakakhel – Lawyer & Legal Consultant provides specialized regulatory support to safeguard your interests.

Legal Framework for Challenging DRAP Decisions

The DRAP Act, 2012, empowers DRAP to issue, suspend, or cancel licenses for manufacturing, import, export, distribution, or sale of drugs and medical devices, as detailed in Sections 7 and 8. Adverse decisions, such as refusal of drug registration under Section 7(2)(z) or license cancellation for non-compliance, must include reasons and an opportunity for hearing, aligning with principles of natural justice under Article 10A of the Constitution of Pakistan, 1973. The Drugs Act, 1976, supplements this by establishing the Central Licensing Board and Registration Board, whose decisions are appealable to the Appellate Board under Section 19. Post-DRAP formation, the Appellate Board retains jurisdiction for licensing and registration appeals, as affirmed in transitional provisions of the DRAP Act (Section 18). Judicial review lies with High Courts under Article 199 for jurisdictional errors or mala fides, and the Supreme Court under Article 184 for constitutional questions. These mechanisms ensure transparency, with DRAP required to notify decisions via its e-portal (e.dra.gov.pk) and provide 15-60 days for responses.

Types of DRAP Licensing Decisions Subject to Challenge

DRAP’s decisions span various therapeutic goods: refusal of new drug registration due to insufficient bioequivalence data or quality concerns; suspension of manufacturing licenses for GMP violations; cancellation of import licenses for adulterated batches; or delisting of medical devices under the Medical Devices Rules, 2017. Common grounds include procedural irregularities (e.g., inadequate notice), substantive errors (e.g., misapplication of pharmacopoeial standards), or bias. For herbal or nutraceutical products, challenges often arise from post-registration variations or advertising violations. Early identification of appealable issues, such as failure to consider submitted dossiers, strengthens cases. Nouman Muhib Kakakhel – Lawyer & Legal Consultant reviews DRAP communications to pinpoint viable challenge grounds.

Initial Response: Show-Cause Notice and Internal Review

Upon an adverse decision, DRAP issues a show-cause notice under Section 10 of the DRAP Act or Rule 59 of the Drugs Rules, 1976, detailing allegations and requiring a response within 15-30 days. This is the first opportunity to challenge: submit a formal reply via the e-portal, including corrective actions, affidavits, lab reports, or expert opinions to address deficiencies. For registration refusals, provide supplementary CTD (Common Technical Document) data under Form 5-F guidelines. If unresolved, request an internal hearing before the relevant DRAP division (e.g., Pharmaceutical Evaluation & Registration Division). DRAP must decide within 60 days, potentially reversing the decision. Failure to respond timely forfeits rights, so track notifications on the PSW (Pakistan Single Window) portal integrated with DRAP. This step resolves 20-30% of disputes informally, avoiding escalation.

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Appeal to the Appellate Board under the Drugs Act, 1976

For unresolved decisions, appeal lies to the Appellate Board, constituted under Section 19 of the Drugs Act, 1976, comprising a Chairman (High Court judge) and two expert members. File within 60 days of the DRAP order, as per Rule 4 of the Drugs (Appellate Board) Rules, 1976, via a memorandum in quintuplicate, including the impugned order, grounds (e.g., error in law or fact), and evidence. Submit to the Board’s Secretary in Islamabad, with a nominal fee (PKR 1,000-5,000). The Board notifies DRAP for a reply within 30 days, then schedules hearings where parties present arguments, witnesses, and cross-examine. Decisions, issued within 90 days, can affirm, modify, or set aside the order, with reasons recorded. Enforcement follows as a civil decree. The Board’s jurisdiction covers pre- and post-DRAP decisions, ensuring continuity. Nouman Muhib Kakakhel – Lawyer & Legal Consultant drafts comprehensive appeals, leveraging precedents like those quashing refusals for procedural lapses.

Judicial Review in High Courts

If the Appellate Board’s decision is unsatisfactory, seek constitutional writs in the relevant High Court (e.g., Islamabad High Court for federal matters) under Article 199. File a petition within 90 days, alleging jurisdictional excess, violation of natural justice, or arbitrariness under the DRAP Act. Include certified copies of prior proceedings and affidavits. The Court may stay enforcement pending hearing, issue notices to DRAP, and admit if alternate remedies are exhausted. Hearings focus on legal errors, not re-appreciating facts, with judgments enforceable via execution proceedings. Appeals to the Supreme Court under Article 185(3) follow on substantial questions of law. This route has succeeded in cases of DRAP’s unreasonable delays or discriminatory refusals, as seen in pharmaceutical import challenges.

Documentation and Evidence Requirements

Strong documentation is crucial: retain all DRAP correspondences, application dossiers, lab analyses, and compliance certificates. For appeals, annex the original application, rejection letter, response to show-cause, and expert endorsements (e.g., WHO-GMP certificates). Affidavits from pharmacologists or affidavits under Section 540 of the Code of Criminal Procedure, 1898, support claims. Digital submissions via e.dra.gov.pk are mandatory for initial stages, with hard copies for the Board. Incomplete filings lead to dismissals, so verify against DRAP’s application forms on dra.gov.pk.

Timelines and Fees

Adhere strictly: 15-30 days for show-cause responses; 60 days for Appellate Board appeals; 90 days for High Court petitions. Delays require condonation applications with sufficient cause (e.g., illness). Fees are minimal: PKR 500 for internal reviews, PKR 2,000 for Board appeals, and court stamps (PKR 100-500) for writs. Processing times vary: 1-2 months internally, 3-6 months at the Board, and 6-12 months in courts. Expedited reviews apply for urgent public health impacts.

Common Challenges and Strategic Tips

Challenges include DRAP’s backlog (over 5,000 pending registrations as of 2025), evidentiary burdens, and enforcement delays. Strategies: engage early legal counsel for dossier reviews; use reliance pathways for WHO-prequalified drugs to fast-track; and opt for mediation under DRAP’s guidelines for amicable resolutions. Post-2025 e-portal updates, digital tracking reduces errors. Avoid pitfalls like generic appeals without specifics, which courts dismiss. Nouman Muhib Kakakhel – Lawyer & Legal Consultant mitigates these through proactive compliance audits and litigation strategy.

Conclusion

Challenging DRAP licensing decisions in Pakistan follows a tiered approach—from internal responses and Appellate Board appeals to High Court review—ensuring accountability while protecting public health. Timely, evidence-driven actions are key to reversal or modification. As DRAP evolves with digital tools like the PSW integration, staying compliant prevents disputes. For seamless handling of appeals or judicial petitions, Nouman Muhib Kakakhel – Lawyer & Legal Consultant offers dedicated expertise, turning regulatory hurdles into opportunities for robust market access.