Even as the government is busy with planning an amendment to Drugs and Cosmetics Rules to make Good Laboratory Practices (GLP) mandatory to all drug-testing laboratories in the country, there are several government laboratories that continue to remain far below the desirable standards. The low standards of the laboratories came to light during a technical audit carried out at the behest of the government on all central and state drug- testing laboratories.

The report of the WHO consultant who carried out the audit suggests that some of these laboratories may not be fit enough for performing its regulatory functions.

It should be noted that the Central Drugs Standard Control Organisation (CDSCO) had taken a view that all drug testing laboratories should be encouraged to go for NABL accreditation until a mandatory law on GLP is in place. This was meant to give sufficient time to the laboratories to prepare themselves to clear the GLP stipulations at a later stage. The WHO consultant's observation has come in the midst of the ongoing World Bank funded Capacity Building Programme of the Central Government to upgrade the drug testing laboratories of the country to the international standards.

According to the audit report, Central Drug Testing Laboratory Kolkatta, Drug Testing Laboratory, Mumbai, Food & Drug Testing Laboratory, Vadodara, Central Drug Testing Laboratory, Mumbai and Food & Drug Testing Laboratory, Bhopal are the only laboratories in good shape. Rest of the government laboratories requires upgradation in a big way before they can go for NABL accreditation.

The CDSCO is of the opinion that all drug-testing laboratories should draw a road map for removing the deficiencies within one year as reported by various technical audits so that they can also become eligible for NABL accreditation.

Some of the pre-requisites for NABL accreditation are Quality Manuel, Quality Policy, Training Manuel, SOPs for Calibration of Instruments / Equipment and SOPs for validation of Test Methods / Reference Standards.

It should be noted that the Mashelkar Committee on drug regulatory reforms had recommended mandatory NABL accreditation for all testing laboratories including government laboratories.