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Overview

Vision

To achieve a healthier nation by ensuring the provision of safe, quality and efficacious Pharmaceutical products and safe & quality cosmetic products.

Mission

To regulate and control the manufacture, importation, sale, storage and distribution of Cosmetics, Devices and Drugs (including nutraceuticals and borderline devices) efficiently and effectively whilst ensuring rational usage.

Introduction

The goal of the Ministry of Health is “Provision of curative, preventive, rehabilitative and promotive services of optimum quality accessible to entire nation”. To achieve this goal provision of safe, efficacious and quality drugs and devices is essential. Therefore the goal of the office of the Medical Technology & Supplies (MT&S) / National Medicines Regulatory Authority (NMRA) is to achieve a healthy nation by ensuring the provisions of safe, quality and efficacious medicinal products and cosmetics.

The Cosmetics, Devices & Drugs (CDD) Act 1980 is the legislative framework which provides the legal authority to regulate Cosmetics, Devices & Drugs in Sri Lanka. National Medicines Regulatory Authority (NMRA) is responsible for implementation of the provisions of the Act.

According to the CDD Act, Director General of Health Services (DGHS) is the Cosmetics, Devices and Drugs Authority. For the purposes of implementation, the delegated Authority to the Director Medical Technology & Supplies (D/MT&S).

Section of Organizational Structure of the Ministry of Healthcare and Nutrition relevant to the Office of the Medical Technology & Supplies

Objectives

  • To ensure that all Pharmaceuticals available in Sri Lanka are of safe, efficacious and acceptable quality
  • To ensure all Cosmetics available in Sri Lanka are of safe and acceptable quality
  • To ensure uninterrupted availability of Drugs, Cosmetics and Medicinal Devices
  • To ensure rational usage

Functions

  • Registering new drugs / cosmetics / medical devices
  • Monitoring and approving changes/variations to those products that are already approved and granted marketing authorization
  • Monitoring and implementing Good Manufacturing Practices for Pharmaceutical products and Cosmetics.
  • Licensing and monitoring of importation, manufacturing, sale, advertisements and distribution Surveillance of quality of drugs available in the market
  • Reviewing and approving of advertisements on CDD.
  • Approving and monitoring of clinical trials.
  • Issuing WHO-format Certificates of Pharmaceutical Products for the purposes of export.
  • Recalling cosmetic, drugs and devices from the market on safety grounds.
  • Human resource development programs.
  • Flying squad activities and prosecutions

Our Services

  • Regulation of Cosmetics, Medical Devices and Medicinal Drugs used in Sri Lanka through a market authorization scheme and a post marketing surveillance system.
  • Inspection of manufacturing premises for compliance of Good Manufacturing Practices.
  • Inspection and licensing of retail and wholesale establishments of pharmaceuticals and vehicles used to transport pharmaceuticals.
  • Monitoring of suspected adverse drug reactions.
  • Recalling of Cosmetics, Medical Devices and Medicinal Drugs from the market on safety grounds.
  • Control of advertisement on medicinal drugs.
  • Control of Narcotics, Psychotropic substances, and Precursors used as medicines, industrial chemicals or used for other scientific purposes.
  • Regulation of clinical trials.
  • Development of guidelines and manuals on medicines and related practices.
  • Training of healthcare professionals and their students with related to Cosmetics, Devices & Drugs Act and its regulations.
  • Awareness programs for the general public.

Quality