National Medicines Regulatory Authority Act, No. 5 of 2015

The National Medicines Regulatory Authority Act, No. 5 of 2015 was certified on 19 March 2015 and commenced on 1 July 2015. It established the NMRA as a body corporate to regulate all medicines, medical devices, borderline products, and cosmetics in Sri Lanka. The Act is the central legal framework for the Senaka Bibile National Drug Policy — ensuring safe, efficacious medicines at affordable prices.

NMRA replaced the Cosmetics, Devices and Drugs Authority (CDDA) established under Act No. 27 of 1980. With 147 sections across 7 Chapters, it is the most complex piece of health legislation under the Ministry of Health's portfolio. Notably, NMRA is self-funded through regulatory fees — it has received no Treasury allocation since 2017.

Source

Full text: NMRA Act (LawNet) | Sri Lanka Law | Full PDF | 147 sections in 7 Chapters. No amendments. Repeals CDDA Act No. 27 of 1980.

Act Structure

The Act is organized into 7 Chapters with multiple Parts. The structure mirrors the NMRA's regulatory scope — separate chapters for medicines, medical devices, and borderline products, each with their own evaluation committees and registration frameworks.

Chapter	Sections	Topic	Summary
I	S.1-29	NMRA Establishment	Body corporate, 13-member Board, CEO, Fund, financial independence, scheduled institution
II	S.30-40	Advisory Committee & Lab	National Advisory Committee, National Medicines Quality Assurance Laboratory (NMQAL)
III	S.41-65	Medicines	Medicines Regulatory Division, MEC, offences, registration & licensing of medicines
IV	S.66-86	Medical Devices	Medical Devices Regulatory Division, MDEC, offences, registration & licensing
V	S.87-105	Borderline Products	Borderline Products Regulatory Division, BPEC, offences, registration & licensing
VI	S.106-118	Collective Provisions	Common provisions, Manufacturing Regulatory Division, pricing of medicines (S.118)
VII	S.119-147	Miscellaneous	Pharmacy licensing, appeals, Authorized Officers, offences, rules/regulations, repeal of CDDA Act (S.144), transitional provisions, interpretation

Chapter I — NMRA Establishment (Key Sections)

Section	Topic	Summary
2	Establishment	Creates NMRA as a body corporate with perpetual succession and common seal
3	Objects	Ensure availability of safe medicines at affordable prices; promote rational use; encourage local manufacturing
4	Constitution	13 members: 3 ex-officio + 10 appointed by Minister
5	Chairman	Appointed by Minister in consultation with the Authority
6	Conflict of interest	No member may have pharmaceutical industry involvement within prior 3 years
10	Meetings	Quorum of 7; majority vote; Chairman has casting vote
14	Powers and functions	Registration, licensing, pricing, GMP enforcement, clinical trials, pharmacovigilance
15	CEO	Appointed by Authority in consultation with Minister; postgraduate degree required; 3-year term
18	Fund	Self-funded through regulatory fees — no Treasury allocation since 2017
26	Directions	Minister may give directions on policy
28	Scheduled institution	NMRA deemed a scheduled institution

Chapter VI — Pricing (S.118)

Aspect	Detail
Authority	NMRA has legal power to set and control MRP for all medicines, devices, and borderline products (S.14(q), S.118)
Pricing Committee	Determines initial prices and advises Minister on revisions
Formula (2025)	MRP = CIF + DT + SCTM (Cost, Insurance, Freight + Duties/Taxes + Supply Chain Markup)
Review frequency	Twice per year; exchange rate recalculated quarterly
Scope (Nov 2025)	500 medicines under MRP controls (up from 48 in 2016)

Statutory Bodies

6 Legally Active0 Obsolete

▶National Medicines Regulatory Authority (NMRA)Legally ActiveSections 2-29

Organisation/statutory-body

▶National Advisory CommitteeLegally ActiveSections 30-37

Organisation/statutory-body

▶Medicines Evaluation Committee (MEC)Legally ActiveSections 43-48

Organisation/statutory-body

▶Medical Devices Evaluation Committee (MDEC)Legally ActiveSections 68-73

Organisation/statutory-body

▶Borderline Products Evaluation Committee (BPEC)Legally ActiveSections 89-94

Organisation/statutory-body

▶Appeals CommitteeLegally ActiveSection 123

Organisation/statutory-body

NMRA Board Composition

Under Section 4, the Authority comprises 13 members — a mix of ex-officio government officials and minister-appointed professionals with strong conflict-of-interest safeguards.

Ex-Officio Members (3)

#	Role	Note
1	Director-General of Health Services	Ex-officio (S.4, S.8)
2	Secretary to the Treasury (or nominee)	Ex-officio (S.4, S.8)
3	Chief Executive Officer of the NMRA	Ex-officio; functions as Secretary to the Authority (S.4, S.15)

Appointed Members (10, appointed by Minister of Health)

#	Role	Note
4-7	4 Specialist clinicians	From Ministry of Health: Medicine, Surgery, Paediatrics, Ob/Gyn (S.4)
8	Professor of Pharmacology	Rotational 3-year appointment, in consultation with Deans of Faculties of Medicine (S.4)
9	Professor or Senior Lecturer in Pharmacy	Rotational 3-year appointment, in consultation with Deans of relevant Faculties (S.4)
10-13	4 Professionals	Persons of eminence in management, law, accountancy, and health (S.4)

Conflict of Interest (Section 6)

The Act has one of the strongest conflict-of-interest provisions in Sri Lankan statutory body legislation. No person may be appointed who has been engaged in any employment or assignment in the pharmaceutical industry within the 3 years immediately prior to appointment. The Minister must satisfy himself that no appointee has financial or other conflict of interest.

Recent Leadership

Period	Chairman	Notes
~2021-2023	Prof. Asita de Silva	Resigned circa early 2023
Oct 2023-present	Dr. Ananda Wijewickrama	Senior Consultant Physician at IDH; first health official to receive COVID vaccine in Sri Lanka

Period	CEO	Notes
~2020-Nov 2023	Dr. Vijith Gunasekera	Removed following document shredding scandal
Jan 2024-May 2025	Dr. Saveen Semage	Resigned citing threats to his life after intruders broke into his home

Organizational Structure

The NMRA has a complex organizational structure with 4 Regulatory Divisions, 3 Evaluation Committees, and several specialized bodies:

Body	Sections	Function
Medicines Regulatory Division	S.41-42	Regulates medicines registration, licensing, and compliance
Medicines Evaluation Committee (MEC)	S.43-48	Scientific and technical review of medicines for registration
Medical Devices Regulatory Division	S.66-67	Regulates medical devices
Medical Devices Evaluation Committee (MDEC)	S.68-73	Technical evaluation of medical devices
Borderline Products Regulatory Division	S.87-88	Regulates products at the boundary between medicines and cosmetics/foods
Borderline Products Evaluation Committee (BPEC)	S.89-94	Evaluation of borderline products
Manufacturing Regulatory Division	S.115-117	Enforces GMP compliance for manufacturing sites
Pricing Committee	S.118	Determines MRP for medicines and products
National Advisory Committee	S.30-37	Advisory body to the Authority
National Medicines Quality Assurance Laboratory (NMQAL)	S.38-40	Quality testing of medicines
Appeals Committee	S.123	Hears appeals against NMRA decisions

Key Regulatory Frameworks

Registration and Licensing (Medicines: S.58-65)

Step	Section	Description
Mandatory registration	S.58	No medicine may be imported, manufactured, or sold without NMRA registration
Application	S.59	Submitted via eNMRA online portal
Evaluation	S.43-48	MEC conducts scientific review; Pricing Committee provides price recommendation
Registration	S.60	Provisional registration (1-2 years) then full registration
Licensing	S.63	Separate license for import, manufacture, distribution
Renewal	S.64	Periodic renewal required
Cancellation	S.65	For non-compliance, safety concerns, or fraud

GMP Compliance (S.51)

The Act mandates that all manufacturing sites — local and foreign — must adhere to Good Manufacturing Practices as defined by the World Health Organization (WHO).

Aspect	Detail
Standard	WHO GMP guidelines (and subsequent updates)
Scope	Both local and foreign manufacturing sites
Inspection	Risk-based GMP inspections per WHO guidelines
Compliance	PIC/S standards also recognized
Post-marketing	Ongoing surveillance for GMP compliance

Pharmacy Regulation (S.119-121)

Provision	Section	Detail
Pharmacy licensing	S.119	All pharmacies must obtain an NMRA license
Good Pharmacy Practices	S.120	Compliance with GPP mandatory
Regulations	S.121	Minister may make pharmacy-specific regulations

Predecessor: Senaka Bibile National Drug Policy

The NMRA Act is the legislative culmination of the Senaka Bibile National Drug Policy, which transformed pharmaceutical regulation globally:

Year	Milestone
1971	Wickremasinghe-Bibile Commission report recommends generic prescribing and a national formulary
1971	State Pharmaceuticals Corporation (SPC) established — Prof. Bibile as founder Chairman
1977	Prof. Bibile dies under circumstances some suspect were connected to pharmaceutical industry opposition
1980	CDDA Act No. 27 of 1980 establishes the Cosmetics, Devices and Drugs Authority
1987	CDDA Amendment Act No. 25 of 1987
2015	NMRA Act replaces CDDA — implements the Bibile vision with modern regulatory framework

Global Impact

The Sri Lankan model of essential medicines — pioneered by Senaka Bibile — was adopted by the WHO as the foundation for the WHO Essential Medicines List concept and influenced pharmaceutical policies across the developing world through UNCTAD and the Non-Aligned Movement.

Financial Independence (Section 18)

NMRA is unique among Sri Lankan statutory bodies in being completely self-funded:

Aspect	Detail
Treasury funding	None since 2017
Revenue sources	Registration fees, licensing fees, inspection fees, renewal fees
Fund	Fund of the Authority (S.18)
Capital projects	NMQAL laboratory (~Rs. 5 billion), new office complex — all from generated funds
Audit	Annual audit (S.20); NMRA deemed a scheduled institution (S.28)

Key Regulations (Under S.142)

Regulation	Year	Key Provisions
Medicines Regulations	2019	Comprehensive rules on registration and licensing process
Pricing Regulations	2019	Legal mechanism for setting ceiling prices on essential medicines
Clinical Trial Regulations	2019	Formal regulation of clinical trials in Sri Lanka
Registration & Licensing (Fees) Regulations	2025	Revised fee structure (Gazette No. 2452/39)

Amendment Timeline

1971

Wickremasinghe-Bibile Commission report

Prof. Senaka Bibile and Dr. S.A. Wickremasinghe published their report recommending a national drug policy based on generic prescribing, creation of the Ceylon Hospital Formulary (~630 drugs), and establishment of a state body to regulate the pharmaceutical trade.

1971

State Pharmaceuticals Corporation established

Prof. Senaka Bibile appointed founder Chairman of the SPC by Minister T.B. Subasinghe. SPC centralized all drug imports through worldwide bulk tenders, dramatically reducing pharmaceutical costs. This model influenced the WHO Essential Medicines List concept.

1980

Cosmetics, Devices and Drugs Act enacted

Act No. 27 of 1980 established the Cosmetics, Devices and Drugs Authority (CDDA) to regulate manufacturing, importation, sale, and licensing of cosmetics, devices, and drugs. Amended by Act No. 25 of 1987.

2015

National Medicines Regulatory Authority Act enacted

Act No. 5 of 2015, certified 19 March 2015, commenced 1 July 2015. Established NMRA as successor to CDDA. 147 sections in 7 Chapters. Created dedicated regulatory divisions and evaluation committees for medicines, medical devices, and borderline products. Repealed CDDA Act (S.144).

2017

NMRA achieves financial independence

NMRA becomes fully self-funded through regulatory fees — no longer receiving any allocation from the National Treasury. Revenue from registration, licensing, inspection, and renewal fees covers all operational and capital costs.

2019

Major regulations gazetted

Three key regulations issued: Medicines Regulations (registration and licensing process), Pricing Regulations (MRP mechanism for the Pricing Committee), and Clinical Trial Regulations (formal regulation of clinical trials in Sri Lanka).

2023

Immunoglobulin scandal

NMRA revealed forged documents used to import Human Immunoglobulin that failed quality tests (contained saline contaminated with Enterobacter hormaechei). Rs. 144 million misappropriated. Former Health Minister Keheliya Rambukwella arrested in February 2024.

2023

Drug pricing injunction

In December 2023, a court injunction halted NMRA price controls after pharmaceutical importers challenged the pricing mechanism. Price controls on essential medicines suspended pending resolution.

2025

WHO integrity initiative hosted

In February 2025, NMRA hosted the world's first UN-assisted corruption risk self-assessment for a national medicines regulator, jointly supported by WHO and UNODC. Part of Sri Lanka's 'Clean Sri Lanka' project.

2025

Parliament approves pricing reform

In October 2025, Parliament approved a major pricing reform: MRPs and Maximum Ceiling Prices (MCPs) for all medicine categories. Formula: MRP = CIF + DT + SCTM. By November 2025, NMRA resumed price controls and reduced prices of 500 medicines.

No Amendments — But Major Regulatory Evolution

The primary Act text has not been amended since 2015. However, the NMRA's operational framework has evolved significantly through:

• Gazette notifications for pricing (48 → 60 → 500 medicines under MRP)
• 2019 regulations for medicines, pricing, and clinical trials
• 2025 Parliamentary pricing reform resolving a court injunction that had halted price controls
• The repealed CDDA Act (S.144) and transitional provisions (S.145) ensured continuity

Entity Relationships & Governance

Governance Hierarchy (1952 Design)

Level 1: Minister of HealthActiveNational

Policy authority: appoints 10 Board members and Chairman (S.4, S.5), gives directions on Authority policy (S.26), approves rules and regulations (S.141-142)

Level 2: National Medicines Regulatory Authority (NMRA)ActiveNational

Body corporate (S.2): 13 members (3 ex-officio + 10 appointed); registers and regulates medicines, medical devices, and borderline products; sets MRP for medicines; self-funded through regulatory fees; quorum of 7 (S.10); subject to Minister's directions (S.26)

Level 3: Evaluation Committees (MEC, MDEC, BPEC)ActiveNational

Technical evaluation bodies: MEC (S.43-48), MDEC (S.68-73), BPEC (S.89-94); conduct scientific review of products for registration; include Panels of Experts; bound by secrecy declarations

Level 4: Chief Executive OfficerActiveOperational

Executive head (S.15): appointed by Authority in consultation with Minister; must hold postgraduate degree in medicine/pharmacology/pharmacy; 3-year term; administers day-to-day affairs; summons Board meetings; functions as Secretary to the Authority

Level 5: Regulatory Divisions and StaffObsoleteOperational

4 Regulatory Divisions: Medicines (S.41), Medical Devices (S.66), Borderline Products (S.87), Manufacturing (S.115); staff are public officers (S.27); Authorized Officers have enforcement powers (S.124-129)

Current Replacement Structure (Post-1989)

Level 1: NationalNational

Minister of Health exercises policy authority; NMRA operates as an autonomous, self-funded body corporate regulating all medicines, medical devices, borderline products, and pharmacies nationally

Level 2: ProvincialProvincial

Not applicable — NMRA's jurisdiction is national

Level 3: RegionalRegional

Not applicable

Level 4: LocalLocal

Enforcement through Authorized Officers (S.124) who have powers of entry, inspection, seizure, and prosecution across all premises

Data Confidence

Legislative Framework

high

Historical Details

high

Current Operational Status

high

Recent Controversies

Immunoglobulin Scandal (2023-2024)

Forged documents were used to import Human Immunoglobulin that failed quality tests — containing saline contaminated with Enterobacter hormaechei instead of the active ingredient. Rs. 144 million was misappropriated. Former Health Minister Keheliya Rambukwella was arrested in February 2024. Case ongoing.

Drug Pricing Court Battle (2023-2025)

In December 2023, pharmaceutical importers obtained a court injunction halting NMRA price controls. The dispute centered on the legal mechanism for determining MRP. Parliament resolved the deadlock in October 2025 by approving a new pricing reform, and NMRA resumed controls — reducing prices of 500 medicines by November 2025.

WHO Integrity Initiative (2025)

In February 2025, NMRA hosted the world's first UN-assisted corruption risk self-assessment for a national medicines regulator, supported by WHO and UNODC.

Research Gaps

• Full composition details of MEC, MDEC, BPEC, and Appeals Committee are behind legislative database paywalls
• Meeting frequency of the Authority Board is not specified in the Act
• Whether the National Advisory Committee has been constituted and meets regularly is unknown
• Complete list of all gazette notifications and regulations issued under S.142 is not consolidated publicly
• Status of the NMQAL laboratory construction not publicly documented
• NMRA's WHO maturity level progression (currently Level 1, targeting Level 3) — timeline not publicly documented
• Detailed breakdown of NMRA Fund revenue and expenditure beyond annual reports not publicly accessible
• Current CEO appointment status following Dr. Semage's May 2025 resignation not confirmed in public sources