Last Updated on February 23, 2022
History
Central Drug Laboratory was established in 1953 in an old Naval Barrack Defense Housing Society, Karachi, for the analysis of drugs / medicines under the Drugs & cosmetics Act of 1940. The role of Central Drugs Laboratory emerged further by the introduction of the Drugs Act, 1976 and DRAP Act, 2012.
The current building which was acquired by CDL in year 2003 has been transformed into the current shape via a number of structural modifications. Since its establishment CDL has played a vital role in maintaining quality standards by the manufacturers and importers of drugs / medicines and has proved itself to be one of the vital organs of the Drug Regulatory system of Pakistan.
Renovation & Up-gradation
Background
WHO audited quality control laboratories of Pakistan following Punjab Institute of Cardiology incidence and concluded that the laboratories in Pakistan are running below the standards and unable to detect such cases in future as well and recommended overall up-gradation of laboratories especially central drugs laboratory, Karachi so that effective surveillance of drugs/ medicines can be implemented.
Upon receipt of report from WHO up-gradation of CDL was planned to make one of the leading laboratory of the region complying with ISO 17025 standard and WHO TRS 957 annex 1, good practices in pharmaceutical quality control laboratories.
The up-gradation was planned to develop new laboratories in Central Drugs Laboratory with required environmental conditions and safety considerations, moreover, purchase of sophisticated and precise equipment was planned.
Current Status
Currently the lab has upgraded its infrastructure and procured sophisticated equipment for the following laboratories in CDL
- Chemical Testing Labs.
- Physical Testing Labs.
- Microbiological Labs.
- Light Sensitive Drugs Testing Labs.
This up-gradation has enabled to perform testing activities as per the following scope:
- Compliance testing of APIs, Pharmaceutical excipients and Pharmaceutical products employing official methods including Pharmacopeial methods, validated and approved MOTs of manufacturers and validated analytical procedures developed by the laboratory.
- Investigative testing of suspicious, illegal, counterfeit substances or products, submitted for examination by Federal Drug Inspectors, customs or other law enforcing agencies.
Achievements
- The Laboratory has successfully been audited by WHO for prequalification of laboratory
- The Laboratory has successfully been audited by PNAC for accreditation to ISO 17025:2017 standard and the same has been recommended by the panel.
Collaborations
United States Pharmacopoeia Convention through its program Promoting Quality of Medicine plus has donated following equipment for test/analysis of PPEs used for Covid-19
Future Programs
Up-gradation further to establish National Chemical Reference Standard Centre, this centre will cater for requirements of national reference standards to improve the quality of therapeutic goods in Pakistan. Moreover, up-gradation to establish the lab as research centre for research in therapeutic goods in Pakistan.
Contact Details
Address: Central Drugs Laboratory, 4-B, SMCHS, Block B, Karachi.
Phone No.: +92-21-34392159 +92-21-34382979