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.
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.
Improve access to quality medicines, healthcare products and cosmetics.
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.
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 Saveen Semage is a public health specialist. He graduated from University of Ruhuna and completed his post graduate studies at PGIM, University of Colombo and University of Melbourne, Australia. He was former Director, Preventive Medicine in Sri Lanka Army and also served in World Health Organization in Timor Leste and South East Asia Regional Office. He was CEO,NMRA from Nov 2021 to May 2022.
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)
1. Vice president of the College of Surgeons of Sri Lanka
2. Secretary of the Specialty Board in General Surgery- Post Graduate Institute of Medicine (PGIM), University of Colombo
3. Board member of the Board of Studies in Surgery- Post Graduate Institute of Medicine (PGIM), University of Colombo
4. Immediate past president of the Association of General Surgeons of Sri Lanka
5. Post Graduate examiner of the Post Graduate Institute of Medicine (PGIM)
6. Undergraduate examiner for the medical faculties under the University Grants Commission
7. Examiner of Examination to Register to Practice Medicine (ERPM) of the Sri Lanka Medical Council
8. Studied at the University of Colombo, Faculty of Medicine
9. Educated at Royal College, Colombo
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)
1. Consultant Physician of the National Hospital of Sri Lanka.
2. Honorary Senior Lecturer of Medicine of the Faculty of Medicine, University of Colombo.
3. Examiner and trainer for Post Graduate PGIM MD exams of Medicine, Sports Medicine, Geriatric Medicine, Emergency Medicine, Community Medicine, Clinical Nutrition, Emergency Medicine of OMF Surgery, Venereology and Haematology.
4. Examiner and Trainer for PGIM diploma exams of Family Medicine, Disaster Management, and Geriatric Medicine.
5. Examiner of Final MBBS of Universities of Colombo, Kelaniya, KDU and Sri Jayawaredenapura.
6. Member of the Ethical Committee of the National Hospital, Expert committee for communicable diseases of SLMA, Board of study of Sports and exercise Medicine, Board of study of Disaster Management.
7. Ceylon College of Physicians Council member and nominee for the NMRA.
8. Examiner for ERPM exams of the SLMC.
9. Primary and Secondary Education at S.Thomas' College, Mount Lavinia. Medical Education at Faculty of Medicine, University of Colombo.
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. Palitha Kumarasinghe is a Senior President’s Counsel specialized in Civil and Commercial matters. Mr. Kumarasinghe enrolled as an Attorney at Law of the Supreme Court of Sri Lanka on 27th September 1982 and was appointed as a President’s Counsel by His Excellency the President with effect from 7th July 2006.
Mr. Kumarasinghe is in active practice in the District Court of Colombo, Commercial High Court, Civil Appellate High Court of Colombo and the Superior Courts. He is the Counsel for several State and Private Banks and Finance Houses. He has very wide experience in Debt Recovery matters and is a regular Speaker in Banking and Debt Recovery Law Sessions and many other Corporate Law matters in National Law Conferences, Junior National Law Conferences, Continuing Legal Education Programmes conducted by the Bar Association of Sri Lanka, the Association of Corporate Lawyers, Sri Lanka and the Colombo Law Society. He has been a Member of the Bar Council of Bar Association of Sri Lanka for the past 36 years.
Mr. Kumarasinghe is an Independent Non-Executive Director of Commercial Bank of Ceylon PLC, a Member of the University Grants Commission of Sri Lanka, a Member of the Law Commission of Sri Lanka and the Chairman of the Standing Committee on Legal Studies of the University Grants Commission.
Mr. Kumarasinghe was a member of Public Service Commission of Sri Lanka from 10th April 2006 to 9th April 2009 and from 13th May 2011 to 12th May 2014. He was a Member of the Incorporated Council of Legal Education, the Chairman, Environmental Council established under the National Environment Act, a Member of the Advisory Commission on Intellectual Property established under the Code of Intellectual Property Act. Mr. Kumarasinghe has previously served as an Independent/ Non-Executive Director of Laugfs Gas PLC and Nawaloka Hospitals PLC.
Mr. Sujeewa Mudalige
Commission Member of the Securities and Exchange Commission of Sri Lanka
(Nominee of the honorable Minister of Health)
Mr. Sujeewa Mudalige counts over 30 years of experience as a Chartered Accountant. He has vast experience as the Audit Committee Chair in both public and private sector organizations. Mr. Mudalige recently retired as the Managing Partner of PricewaterhouseCoopers (PwC), Sri Lanka and currently serves as Chairman and as an Independent Non-Executive Director in many listed and private companies.
He is a past President of the Institute of Chartered Accountants of Sri Lanka. He currently serves as a commission member of the Securities and Exchange Commission of Sri Lanka and held several such other positions locally and globally during the span of his career.
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)
Mrs. Tamara Adikari, a Special Grade Officer of the Sri Lanka Accountancy Service, is currently serving as the Chief Financial Officer of the Ministry of Finance, Economic Stabilization, and National Development.
She joined the Sri Lanka Accountancy Service in 1990 and worked in a number of key ministries and departments, such as the Sri Lanka Railways Department, the Superintendent of Police Office at Kelaniya, the Criminal Investigation Department, the Education Publications Department, the Ministry of Education, the Sri Lanka Army, the Ministry of Defence, and the Ministry of Transport. She is an officer with more than 34 years of experience.
She received her first degree qualification from the University of Sri Jayawardenepura with a second-class upper division pass in the BSc Special Degree in Business Administration. She obtained her Master's degree in Economics from the University of Kelaniya.
She is a member of the Institute of Chartered Public Finance Accountants of Sri Lanka. She is a justice of peace for the whole island.
Prof. Priyadarshani Galappaththi
Senior professor of pharmacology, Faculty of Medicine, Colombo
(Nominee of University)
Dr. (Mrs.) LCPT Liyanaarachchie (B. Sc. Pharmacy sp.. phD)
Director/NMQAL
Mrs. Gowri Kathriarachchi
Chief pharmaceutical Analyst
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)
Mr. Arjuna Pathmaperuma
Director Regulatory (Acting)
dr@nmra.gov.lk
Mr. P.G.K.De Silva
cpa@nmra.gov.lk
Mr.B.M.W.Balasooriya
pa21@nmra.gov.lk
Mrs. J.A.G.S.Ranasinghe
Head of the Medicine Regulatory Division
pa1@nmra.gov.lk
Miss. K.N.L.Karunathilaka
Focal Point of the New / WOR & Shipment Clearance
P35@nmra.gov.lk
Mrs. K.G. David
Focal Point of the Additional Evaluation activities
pa10@nmra.gov.lk
Mrs. W.P. Surangi
Focal Point of the Re-Registration Evaluation activities
pa15@nmra.gov.lk
Miss. M.M.D.U. Cooray
Focal Point of the Personal User License & Advertising (Medicine)
aa19@nmra.gov.lk
Miss.G.M.D.T.Gurugalgoda
Pharmaceutical Assessor
pa5@nmra.gov.lk
Mr.Asantha Abeywikrama
Pharmaceutical Assessor
pa6@nmra.gov.lk
Mrs. J.W.K.U. Siriwardana
Focal point of the Variation
pa9@nmra.gov.lk
Mrs. K.A.L.S. Karunarathne
Pharmaceutical Assessor
pa28@nmra.gov.lk
Mrs. Darshani Silva
Pharmaceutical Assessor
pa18@nmra.gov.lk
Miss. C.H.E. Senevirathne
Assistant Pharmaceutical Assessor
aa8@nmra.gov.lk
Mrs. S.M.D.U. Silva
Assistant Pharmaceutical Assessor
aa3@nmra.gov.lk
Miss. R.H.U.L. Hewage
Assistant Pharmaceutical Assessor
aa13@nmra.gov.lk
Miss. W.R.H.L. Rathnasekara
Assistant Pharmaceutical Assessor
aa14@nmra.gov.lk
Miss. Vidushi Silva
Assistant Pharmaceutical Assessor
aa21@nmra.gov.lk
Mrs. M.J.F. Riyasha
Head of the Device Regulatory Division
P33@nmra.gov.lk
Mrs. S.S. Shobia
Pharmaceutical Assessor
pa2@nmra.gov.lk
Ms. Shyalika Neelanayani
Pharmaceutical Assessor
pa13@nmra.gov.lk
Ms.Hirunika Karunarathne
Pharmaceutical Assessor
pa17@nmra.gov.lk
Mrs. K.G.N.D. Jayaweera
Assistant Pharmaceutical Assessor
aa11@nmra.gov.lk
Mrs. D.M.N.P.K. Doranegoda
Assistant Pharmaceutical Assessor
aa16@nmra.gov.lk
Miss. H.M. Oshini Imalka
Assistant Pharmaceutical Assessor
aa20@nmra.gov.lk
Miss.M.K.C.Perera
Assistant Pharmaceutical Assessor
aa17@nmra.gov.lk
Mr. W.M. Pabasara
Assistant Pharmaceutical Assessor
aa1@nmra.gov.lk
Miss. S.Yalini
Assistant Pharmaceutical Assessor
aa2@nmra.gov.lk
Mrs. Wasana Welipitiya
Head of the Manufacturing Regulatory Division
pa7@nmra.gov.lk
Mrs. Chathunika Nilmani Gunawardana
Pharmaceutical Assessor
pa14@nmra.gov.lk
Mr. Chamara Galkanda
Assistant Pharmaceutical Assessor
aa5@nmra.gov.lk
Mrs. K.T.S.S. Karunathilaka
Assistant Pharmaceutical Assessor
aa15@nmra.gov.lk
Ms. H.K.P.P. Dayawansa
Pharmaceutical Assessor
Head of the Borderline Products Regulatory Division
P15@nmra.gov.lk
Mrs. W.D.D.D. Kamalasena
Pharmaceutical Assessor
pa19@nmra.gov.lk
Mrs. S.S. Shobia
Pharmaceutical Assessor
Head of the Cosmetics Regulatory Division
pa2@nmra.gov.lk
Miss.Shashini Chathurika
Assistant Pharmaceutical Assessor
aa22@nmra.gov.lk
Ms. R.P.D. Dinuda
Pharmaceutical Assessor
Head of the Pharmacy Regulatory Division
pa20@nmra.gov.lk
Ms. Shamila Niranjali Hettiarachchi
Pharmaceutical Assessor
pa12@nmra.gov.lk
Mr. Sajith Venshka Yatagampitiya
Pharmaceutical Assessor
pa16@nmra.gov.lk
Mr. P.C.P. Munasinghe
Assistant Pharmaceutical Assessor
aa18@nmra.gov.lk
Mrs. Janitha Punchihewa
Pharmaceutical Assessor
Head of the Clinical Trials Regulatory Division
pa4@nmra.gov.lk
Mrs. D.D.U. Wijerathna
Pharmaceutical Assessor
Head of the Pharmacovigilance Division
Mr. W.W.C. Dissanayake
Pharmaceutical Assessor
Head of the Division (Acting)
pa24@nmra.gov.lk
Mr. A.J.M.N. Bandara
Pharmaceutical Assessor
Focal Point of the QMS & Benchmarking Unit
P19@nmra.gov.lk
Ms. Niluka Weerasekara
Pharmaceutical Assessor
Head of the Pricing Regulatory Division
pa8@nmra.gov.lk
Mrs. T.L.I. Srilal
Assistant Pharmaceutical Assessor
aa4@nmra.gov.lk
Mr.Asantha Abeywikrama
Pharmaceutical Assessor
pa6@nmra.gov.lk
Mrs. J.A.C. Perera
Pharmaceutical Assessor
Focal Point of the Advertising Unit
pa25@nmra.gov.lk
Mr. W.W.C. Dissanayake
Pharmaceutical Assessor
Head of the Market Control Division
pa24@nmra.gov.lk
Mr. K.T.P. Ranadewa
Pharmaceutical Assessor
pa29@nmra.gov.lk