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The Central Drugs Standard Control Organisation (CDSCO) has formed a team of drug control officials to conduct random inspections on drug testing labs across the country to check the status of compliance followed by these labs as per the global regulatory requirements. There are around 220 accredited drug testing labs in the country as of today.
The inspections which will be conducted with coordination from the respective state drug controllers have been revived and planned after a gap of 13 years in the wake of increasing scrutiny from global regulators towards quality of the products coming from India. Regulators globally during their audit visits at Indian sites have issued in total 19 Form 483 last year as part of their observations on data integrity.
“Apart from inspecting the manufacturing units, drug testing labs need to be inspected to ascertain whether the licensed conditions as per Drugs and Cosmetics Act issued to the 220 accredited labs are being complied with or not as labs play a major role in assessing drug quality,” says Drug Controller General of India Dr G N Singh.
The inspections will be done based on the location and overall performance of the lab, he further adds.
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.
“While the drugs that get exported have a stringent quality assurance system put in place and insisted upon by the importing companies’ internal requirements, concerns have been raised on the quality of surveillance of the indigenously manufactured drugs for the domestic market,” stated the draft pharmaceutical policy report. It added that many manufacturing units are not compliant with the World Health Organization (WHO) good manufacturing practices (GMP) or the good laboratory practices (GLP).
As per the draft policy, there are not enough NABL-accredited labs for conducting frequent and regular tests. The record of regular audit of these labs itself 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.
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