May 10, 2006	Wednesday	Rabi-us-Sani 11, 1427

Please Visit our Sponsor (Ads open in separate window).

ISLAMABAD May 9: The health ministry has failed to bring any improvement in the equipment or replace the officers of the Central Drug Testing Laboratory (CDL), Karachi, who had allegedly been issuing wrong and technically faulty reports, according to documents available with Dawn.

The CDL, which had recently been in the limelight due to a controversy over issuance of wrong and incredible test reports, was allocated Rs16.4 million in 2005-06 budget; however, the lab utilised only Rs6.4 million to strengthen its facilities.

A source in the pharma industry said the laboratory had not validated its equipment. Similarly, it does not have experienced staff for conducting tests because of which 43 of its reports declaring several batches of a medicine as substandard were termed invalid by the National Institute of Health (NIH), Islamabad. The NIH found that all the 43 batches of the medicine complied with the specifications.

Validation - the scientific method for the standardization of equipment used in the testing of drugs — is considered to be the most important factor for reliable reports. If the equipment is not validated, the test reports may be wrong and not credible.

An amendment in the Drugs Act 1976 was introduced in November 2002 to make annual validation of all equipment in the public laboratories mandatory. The test reports of CDL have no value as the drugs are tested on the instruments and machines which have not been validated, the source said.