About Us

Who We Are

The National Medicines Regulatory Authority (NMRA), plays a leading role in protecting and improving public health by ensuring medicinal products available in the country meet applicable standards of safety, quality and efficacy. The Authority regulates medicines, medical devices, borderline products, clinical trials and cosmetics. The National Medicines Quality Assurance Laboratory (NMQAL), charged with ensuring quality of medicinal products, also functions under the purview of the NMRA.

We are an independent authority in the Ministry of Health established in 2015 through an Act of Parliament. The NMRA is governed by a board. The board is responsible for providing strategic leadership and advising on overall functioning of the authority to ensure targets set out in the corporate plan and policies of the government are achieved. The Board doesn’t have any involvement in regulatory decision making. These are the responsibility of the Chief Executive Officer, working with regulatory and other staff and expert advisory committees.

The Authority places great importance on the transparency of its decision-making concerning the market authorization of medicinal products, the context within which such decisions are made, and the conduct of its expert committees as well as the organization’s staff. We strive to ensure regulatory decisions are based on evidence in fairness to all stakeholders.

Our primary objective is to increase patient access to quality-assured medicinal products.

NMRA has a code of conduct in order to help our staff in this respect. This Code of Conduct sets out the standards of conduct to be observed by all NMRA staff, including members of the board and external experts. The aim of this integrity policy is to ensure that Board members and staff continually maintain and improve their integrity, impartiality and independence in order to guarantee the quality of the NMRA’s work and decision-making.

The NMRA ACT

National Medicines Regulatory Authority was established by the Act of Parliament, National Medicines Regulatory Authority Act, No. 5 of 2015. The Act was certified on 19th of March 2015. This replaced the Cosmetics, Devices and Drugs Act, No. 27 of 1980.

Vision and Mission

Our Vision

Improve access to quality medicines, healthcare products and cosmetics

Our Mission

Provide regulatory oversight and evidence-based decisions for medicines, healthcare products and cosmetics to ensure their Safety, Quality and Efficacy for the benefit of the people of Sri Lanka

Board Members

Dr. Ananda Wijewickrama

Chairman, Consultant Physician

(Nominee of the honorable Minister of Health)

Dr. Saveen Semage

Director General / Chief Executive Officer, Consultant Community Physician

(Ex-Officio Member)

Dr. Asela Gunawardane

Director General of Health Services, Sri Lanka

(Ex-Officio Member)

Dr. Banukie Jayasuriya

Senior Lecturer, University of Sri Jayewardenepura

(Nominee of University)

Dr. Duminda Ariyaratne

Consultant Surgeon, National Hospital Sri Lanka

(Nominee of Sri Lanka Collage of Surgeons)

Dr. Kosala Karunaratne

Consultant Pediatrician, Lady Ridgeway Hospital, Colombo

(Nominee of the Sri Lanka Collage of Pediatricians)

Dr. Pradeep Kumarasinghe De Silva

Consultant Physician, National Hospital Sri Lanka

(Nominee of Ceylon College of Physicians)

Dr. Sanath Akmeemana

Consultant Gynecologist and obstetrician

(Nominee of the Sri Lanka Collage of Gynecologist and obstetrician)

Mr. Palitha M Kumarasinghe

President's Council

(Nominee of the honorable Minister of Health)

Mr. Sujeewa Mudalige

Commission Member of the Securities and Exchange Commission of Sri Lanka

(Nominee of the honorable Minister of Health)

Mr. Susantha Kahawatta

Director General of Department of Fisheries and Aquatic Resources

(Nominee of the honorable Minister of Health)

Mrs. Tamara Adikari

Chief Financial Officer, Finance Ministry

(Treasury Representative, Ex-Officio Member)

Prof. Priyadarshani Galappaththi

Senior professor of pharmacology, Faculty of Medicine, Colombo

(Nominee of University)

Management Team

Mrs. L.C.P.T. Liyanarachchi

Director/NMQAL

Mrs. Gowrie Kathriarachchi

Acting Diputy Director/NMQAL

Mrs. K.M.Y.K. Karunarathna

Accountant

Mrs. K.P.Y.H.Gunaratne

Acting Assistant Director / ICT

Mrs. Ruvini Yasintha

Acting Admin Officer

Mr. Arjuna Pathmaperuma

Director Regulatory (Acting)

Regulatory Team

Director Regulatory
Chief Pharmaceutical Assessor
Licensing Officer
Medicines Regulatory Division
Medical Device Regulatory Division
Manufacturing Regulatory Division
Borderline Products Regulatory Division
Cosmetic Regulatory Division
Pharmacy Regulatory Division
Clinical Trials Regulatory Division
Pharmacovigilance Division
Inspectorate & Enforcement Division
Information, Education, communication and Research Division
Pricing Regulatory Division
QMS & Benchmarking Unit
Innovation Unit
Advertising Unit
Market Control Division