Drug Regulation in Pakistan: Recent Updates

Drug regulation plays a critical role in ensuring the safety, efficacy, and quality of pharmaceuticals in Pakistan. The regulatory framework, overseen by the Drug Regulatory Authority of Pakistan (DRAP), is vital for protecting public health and maintaining the integrity of the pharmaceutical sector.

Recently, significant updates have been made to the Drug Research Rules under S.R.O 168(I) 2025. These amendments aim to enhance the drug approval process and promote research and development in the pharmaceutical industry.

Key Updates from S.R.O 168(I) 2025:

1. Streamlined Approval Process: The new regulations focus on expediting the drug approval process to ensure timely access to essential medications.
2. Increased Focus on Research: There is a renewed emphasis on promoting research activities, particularly in the development of new drugs and therapies.
3. Enhanced Quality Control Measures: The amendments introduce stricter quality control measures to ensure that drugs meet the required safety and efficacy standards before reaching the market.
4. Collaboration with Stakeholders: The regulations encourage collaboration among various stakeholders, including researchers, manufacturers, and regulatory bodies, to foster innovation in drug development.
5. Public Health Priorities: The amendments reflect a commitment to addressing public health challenges by prioritizing the approval of drugs that target prevalent diseases in Pakistan.

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Complete Notification of Amendments in the Drugs Research Rules

To be published in the Extraordinary Gazette of Pakistan, Part-II
Government of Pakistan
Ministry of National Health Services, Regulations, and Coordination
(Drug Regulatory Authority of Pakistan)

NOTIFICATION

Islamabad, the 18th February 2025

S.R.O. 168(I)/2025 – In exercise of the powers conferred by section 23 of the Drug Regulatory Authority of Pakistan Act, 2012 (XII of 2012), read with section 43 of the Drugs Act, 1976 (XXXI of 1976), the Drug Regulatory Authority of Pakistan, with the prior approval of the Federal Government, is pleased to direct that in the Drugs (Research) Rules, 1978, the following further amendments shall be made, the same having been previously published vide Notification dated 21st February 2023, as required by sub-section (3) of the said section 43, namely:

Amendments in the Rules

(1) In Rule 2, sub-rule (1):

(A) The existing clauses (a) and (aa) shall be renumbered as (ac) and (ae), respectively.

(B) Before clause (ae), renumbered as aforesaid, the following new clauses shall be inserted, namely:

• (a) “Act” shall have the same meaning as assigned in the DRAP Act.
• (aa) “Authority” shall have the same meaning as assigned in the DRAP Act.
• (ab) “Clinical trial” or “clinical study” means any investigation in human subjects intended to discover or verify the clinical, pharmacological, or other pharmacodynamic effects of an investigational product, identify any adverse reactions, or study absorption, distribution, metabolism, and excretion of an investigational product to ascertain its safety and efficacy.

(C) After clause (ac), inserted as aforesaid, the following new clause (ad) shall be inserted:

• (ad) “DRAP Act” means the Drug Regulatory Authority of Pakistan Act, 2012 (XII of 2012).

(D) In clause (b), for the word “Fund”, occurring for the first time, the words “Central Research Fund” shall be substituted.

(2) For the word “Fund”, wherever occurring, except clause (b) of sub-rule (1) of Rule 2, the words “Central Research Fund” shall be substituted.

(3) For Rule 3, the following shall be substituted:

Utilization of Fund:
(1) The Authority may utilize the Central Research Fund for conducting basic and operational research, subject to conditions specified by the Committee.
(2) The Authority may, subject to section 19 of the DRAP Act, utilize the Fund for operation and upgradation of its laboratories, pharmacovigilance centers, antimicrobial consumption surveillance cells, drug information, poison control centers, and digitization of records related to therapeutic goods for international accreditation.
(3) The Authority may facilitate provinces for upgradation of provincial drug testing laboratories and centers as per guidelines issued by the Authority under clause (c) of section 7 of the DRAP Act.

(4) For Rule 4, the following shall be substituted:

Research in Drugs:
Research in drugs shall be conducted at authorized places and by approved persons and shall be categorized as follows:

• (a) Clinical trials
• (b) Non-clinical trials
• (c) Other categories determined by the Authority

(5) In Rule 5:

(A) In the marginal heading, after the word “aid”, insert “for research in drugs”.

(B) After sub-rule (4), insert the following new sub-rule (5):

(5) Applications for grant of aid for research in drugs shall be processed through the Committee on Drugs Research, whereas other fund allocations shall be directly considered by the Authority or a committee constituted for the said purpose.

(6) In Rule 6:

(A) In the marginal heading, after the word “of”, insert the word “drug”.

(B) For sub-rule (4), substitute the following:

(a) The recipient of the aid shall allow an expert or a panel of experts authorized by the Committee to visit the premises where research is conducted and ensure proper utilization of the Central Research Fund.

(7) In Rule 7, for sub-rule (1), substitute:

(1) Research in drugs related to clinical trials shall be conducted as per the guidelines under section 7(c)(xii) of the DRAP Act, aligned with the International Conference on Harmonization – Good Clinical Practices (ICH-GCP) guidelines.

• The Authority may alter requirements in exceptional cases, with proper justification.

(8) For Rule 8, substitute the following:

Committee of Experts on Drug Research:
(1) The Authority shall constitute a Committee of Experts to scrutinize research proposals and recommend fund allocations.
(2) The Committee shall consist of:

• Five professors or scientists in pharmacy, pharmacology, biotechnology, chemistry, or medicine (representing all provinces and ICT).
• One expert to be co-opted by the Authority.
• Director, Pharmacy Services (Convener).
• Nominees from Pharma Bureau and Pakistan Pharmaceutical Manufacturers’ Association (Observers, non-voting).
  (3) The Chairperson shall be appointed annually on a rotation basis among provinces in alphabetical order.
  (4) The Committee shall meet as needed, with a simple majority forming a quorum.
  (5) A sub-committee shall oversee project implementation and recommend actions for non-compliance.
  (6) The Committee may suspend or cancel ongoing research based on violations or complaints.
  (7) An annual report on activities and fund utilization shall be submitted to the Federal Government.

(9) In Rule 9:

(A) Replace “Federal Government” with “Authority” in clause (vi).
(B) Replace “Federal Government” with “Authority” in the proviso.

(10) In Form B, paragraph (5), clause (iv):

• Replace “Federal Government” with “Authority”.

[No. F. 13-1/2022-DD(LA)/DRAP]

Signed: AAMAR LATIF, Additional Director (Legal Affairs)

To:
The Manager, Printing Corporation of Pakistan Press, Islamabad.

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For more detailed information on the specific amendments and their implications, please refer to the official notification: Notification regarding amendments in the Drugs Research Rules S.R.O 168(I) 2025.