History, Policies, and Laws
This page provides an overview of the key regulatory bodies, policies, and legal frameworks that govern clinical research — with particular relevance to herbal and pharmaceutical sciences in Pakistan. PJHPS operates in full awareness of and alignment with these frameworks.
Regulatory Framework in Pakistan
Drug Regulatory Authority of Pakistan (DRAP)
The Drug Regulatory Authority of Pakistan (DRAP) is the primary federal body responsible for regulating therapeutic goods in Pakistan, including medicines, biological products, medical devices, and herbal products. DRAP regulates the conduct of clinical trials under the Drug Regulatory Authority of Pakistan Act, 2012 and the Bio-Study Rules, 2017, which establish the legal and procedural requirements for sponsors and investigators conducting clinical research.
All herbal pharmaceutical products associated with research published on PJHPS are manufactured under GMP-compliant conditions and registered with DRAP — ensuring that our clinical work rests on a foundation of regulatory compliance from the outset.
National Bioethics Committee — Pakistan (NBC)
The National Bioethics Committee of Pakistan (NBC), operating under the Health Research Institute, National Institutes of Health (NIH), is the apex body responsible for formulating ethical guidelines for health research in the country. The NBC promotes ethical norms across healthcare research, medical education, and clinical practice.
Its Healthcare Ethics Committee (HCEC) works with provincial bioethics committees, supports the integration of bioethics into medical and dental college curricula, and develops institutional SOPs for complex clinical decision-making. PJHPS recognises the NBC’s framework as the ethical benchmark for all studies submitted and published on this platform.
Visit NIH Pakistan — www.nih.org.pk
Higher Education Commission of Pakistan (HEC)
The Higher Education Commission of Pakistan regulates academic publishing standards and journal indexing within the country. HEC recognition is a mark of credibility for any research journal operating in Pakistan, affirming its editorial standards, peer-review processes, and academic integrity.
PJHPS is actively pursuing HEC recognition as part of its institutional development roadmap — a step that will open PJHPS-published research to broader academic citation and give contributing university researchers formal HEC-recognised publication credits.
International Standards & Frameworks
International Standard Serial Number (ISSN)
The ISSN is an internationally recognised identifier assigned to periodical publications, affirming their status as registered scientific or academic journals. PJHPS has filed its ISSN application, which is currently in process. Upon issuance, PJHPS will be formally recognised as a registered international periodical — a prerequisite for broader indexing and academic acceptance.
Learn about ISSN — www.issn.org
ICH Good Clinical Practice (GCP) Guidelines
The International Council for Harmonisation (ICH) Good Clinical Practice guidelines provide a unified international standard for the design, conduct, recording, and reporting of clinical trials. These guidelines ensure that data and reported results are credible and that the rights, safety, and wellbeing of trial participants are protected. Investigators submitting to PJHPS are expected to align their study conduct with GCP principles wherever applicable.
Learn about ICH GCP — www.ich.org
Declaration of Helsinki
The Declaration of Helsinki, developed by the World Medical Association (WMA), is the foundational ethical framework for medical research involving human subjects. It establishes principles of informed consent, risk-benefit assessment, vulnerable population protections, and post-study obligations. All research submitted to PJHPS must adhere to the ethical principles set out in the Declaration of Helsinki.
Read the Declaration — www.wma.net
PJHPS Editorial & Submission Policy
Studies submitted to PJHPS are governed by our internal editorial policies, which require investigators to confirm compliance with applicable Pakistani law, DRAP regulations, NBC ethical guidelines, and international GCP standards at the time of submission. Responsibility for the accuracy, legality, and ethical conduct of any listed study rests entirely with the study sponsor and principal investigators.
For full submission guidelines, visit our Submit Your Study page.
This page is reviewed and updated periodically as regulatory frameworks evolve. Last reviewed: 2025.