Rules

Last Updated on July 1, 2025

Federal Government

1.Drugs

Drug Research Rules:

Drug Specification Rules 1978:


2. Medical Devices

The Medical Device Rules, 2017 (as on January 16, 2018)

S.R.O 526(I)/2021 (issued on 30-04- 2021)

S.R.O 1500(I)/2021 (issued on 22-11-2021)

S.R.O 430(I)/2022 (issued on 18-03-2022)

S.R.O 559(I)/2022 (issued on 27-04-2022)

The Medical Device, Rules 2017 (as amended)

3. Alternative Medicines, Health & OTC Products

4. Clinical Trials

5.Ethical Marketing

The Ethical Marketing to Healthcare Professionals Rules, 2021 (as current)

6.Pricing Policy

Drug Pricing Policy, 2018 (as of June 12, 2018)

S.R.O No. 9-13/2016-DDC(P) (issued on January 21, 2019)

S.R.O No. 11-2/2020-DD(P) (issued on July 15, 2020)

S.R.O No. 678(I)/2023 (issued on June 09, 2023)

Drug Pricing Policy 2018 (as amended)

7.Pharmacovigilance

The Pharmacovigilance Rules, 2022

8.Import and Export of Therapeutic Goods

The Drugs (import and Export) Rules, 1976 (Initial version)

The Drugs (Import and Export) Rules 1976 (as amended)

9.Inspectorate and Laboratories

The Drugs (Federal Inspectors, Federal Drug Laboratory and Federal Government Analysts) Rules, 1976 

10.Appellate Board

The Drugs (Appellate Board) Rules, 1976 (as amended)

11. Advertisement

Therapeutic Goods Advertisement Rules, 2025

Provincial and States Governments