You are here: About Us Acheivements

Acheivements

Expected targets and achievements in 2010:

The office MT&S has targeted many activities to be carried out in the year 2010.

  1. Registration of    New chemical entities (NCE)/New generic Products, Cosmetics & Devices.
    • Registration of new drugs (NCE) (6)
    • Registration of new generic products (1839)
    • Re-registration of Drugs (1033)
  2. Re-registration of Drugs, Medical Devices & Cosmetics.
    • Registration of Cosmetics (1686)
    • Registration of Medical Devices (2713)
  3. Issuing of licences to import, manufacturing & transportation of drugs & for wholesale & retail pharmacies. Issuing of licences to import, manufacturing & transportation of drugs & for wholesale & retail pharmacies.
  4. Issue licenses for import drugs (3836), import drugs as samples (2117), drug transportation (2150), manufacturing (159), wholesale pharmacies (445) & retail pharmacies (1740)
    Issuing of licences to import & manufacture cosmetics and devices.
    • Issue licenses for import cosmetics (2914), import cosmetics as samples (584), manufacturing of cosmetics (450), import devices (3518), import devices as samples (3074), manufacture of devices (19)
  5. Carrying out post marketing surveillance eg. issuing circulars on quality failure drugs, GMP inspections, inspection of pharmacies. 
    • Issuing circulars on quality failure drugs (74)
    • Issuing circulars on quality failure (11)
    • Good Manufacturing Practices (GMP) Inspections – 16
    • No. of flying squad activities done – 19
    • No. of pharmacies inspected during flying squad – 78
    • No. of items seized/ detained - 103
  6. Carrying out prosecutions against offences & handling complaints on quality, safety & efficacy of drugs, devices & cosmetics.
    • No. of prosecutions - 07
    • No. of complaints received – 38
    • No. of items seized / detained – 13
  7. Carry out training programmes for health staff & public.
    • For pharmacy owners / pharmacists: 05workshops, 383 participants
  8. Updating the data base, development of web site & a “Net work system” with MSD, SPC and NDQAL to strengthen the management information system
  9. Strengthening of CDD registration & regulation process
    • Updating SOPs
  10. Formation of a multi-stakeholder committee and developing a mechanism and guidelines for the regulation and monitoring of medicines prices
    • Formation of a multi-stakeholder committee
    • Development of Terms of Reference for the committee
    • Development of action plan
  11. Formation of national alliance and national steering committee for implementation of plan of action on Containment of Antimicrobial Resistance (AMR)
    • Conducting awareness programmes


Major Achievements in Year 2011

  1. Development of the web site - in progress
  2. Development of a “Net work system” with MSD, SPC and NDQAL to strengthen the management information system – in progress (MSD is the in charge of this activity)
  3. Strengthening of CDD registration & regulation process
    1. Conducting workshops to develop SOP’s on pre and post marketing surveillance – had 04 workshops & 5 group discussions, prepared the draft SOP document .
    2. Formation of a multi-stakeholder committee and developing a mechanism and guidelines for the regulation and monitoring of medicines prices – had 05 workshops and several group discussions, Formed multi-stakeholder committee, developed TOR for the committee, developed action plan for next two years.
  4. Strengthening existing legislation
    1. Fourth amendment of the Cosmetics, Devices and Drugs Act (1980 No. 27) has been drafted. – in progress.
    2. A new regulation regarding excessive use of “Paracetamol” has been drafted. – Implemented.
    3. A new regulation on Expiry date of Cosmetics has been drafted. – in progress.
    4. New guideline/regulations to strengthen monitoring and controlling of drug advertisements; introducing prior approval for Cosmetics and Medical Devices advertisements has been prepared. – in progress
  5. Implementation of plan of action on Containment of Antimicrobial Resistance (AMR)
    1. Identification of the focal point for AMR – Identified. (DDG/LS) .
    2. Conducting awareness programs for pharmacists and pharmacy owners and prescribers and consumers on rational usage of antibiotic and legal dispensing – Conducted one awareness programme at Anuradhapura. Planned to conduct another meeting on August.
  6. Strengthening the drug advertisement regulating unit of the DRA – Purchased equipments.