The Central Drugs Standard Control Organization (CDSCO) officials are in the process of devising an action plan to inspect drug testing labs for compliance to the Drugs and Cosmetics Rules. This is followed by recent Drug Controller General of India (DCGI)'s directive to the labs in the country to self audit for audit -readiness before a CDSCO inspection.

“It has been mandated that the drug testing labs should verify and assess their compliance levels as per global regulatory requirements before they face an inspection team from the CDSCO,” informed DCGI Dr G N Singh.

CDSCO has formed a team of drug control officials to conduct random inspections on drug testing labs across the country in the wake of increasing scrutiny from global regulators. There are around 220 accredited drug testing labs in the country as of today.

“Labs play a major role in assessing drug quality and CDSCO team has been formed to assess whether the licensed conditions are as per Drugs and Cosmetics Act,” added Dr Singh.

The inspections which will be conducted jointly by CDSCO officials and respective state drug controllers are planned after a gap of 13 years to ascertain whether the licensed conditions are fulfilled.  The inspections will be done based on the evaluation of the lab based on criteria like location and overall performance.

The laboratories for testing drugs and cosmetics must be accredited by the National Accreditation Board for Testing and Calibration Laboratories (NABL), to be deemed technically competent.

These drug testing laboratories approved under Drugs and Cosmetics Rules cater to the testing requirements of manufacturing units that lack specialized facilities. These facilities are inspected every five years at the time of grant of licence to them by the state regulators.


As per draft pharmaceutical policy, there are not enough NABL-accredited labs for conducting frequent and regular tests. The record of regular audit of these labs is also not very encouraging.

The GLP principles, which set the quality standards for the organization to test facilities, cover all aspects of a laboratory’s daily activity, such as the layout of testing and storage areas to prevent contamination, cleaning and calibration of equipment, handling of test animals and recording of test results.