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DCGI directs drug testing labs across country to do self audit before CDSCO inspections

Shardul Nautiyal, Mumbai
Monday, October 9, 2017, 08:00 Hrs  [IST]

To effectively assess the status of compliance across drug testing labs in the country as per global regulatory requirements, Drug Controller General of India (DCGI) has asked the drug testing labs to verify and assess their compliance levels through a self- audit to ensure audit -readiness before a Central Drugs Standard Control Organization (CDSCO) inspection team.

The inspections which will be conducted jointly by CDSCO officials and respective state drug controllers. The joint inspection testing labs is planned after a gap of 13 years.

As per draft pharmaceutical policy released recently, 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.

CDSCO has recently 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 towards quality of the products coming from India. There are around 220 accredited drug testing labs in the country as of today.

“Labs play a major role in assessing drug quality and warrants remedial action through effective inspections similar to what has been done on case of manufacturing units. These inspections will help ascertain whether the licensed conditions are as per Drugs and Cosmetics Act issued to labs are being complied with or not,” says Drug Controller General of India Dr G N Singh.

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 state regulators.

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.


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