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Random Inspection by CDSCO on Drug Testing Labs

Team of drug control officials has been formed by the Central Drugs Standard Control Organisation (CDSCO) in order to conduct inspections on drug testing labs in the country to inspect the status of compliance followed by drug testing labs as per the global regulatory requirements. Approximately 220 labs are accredited drug testing labs across country,

The state drug controllers are involved in inspections which are revived and planned following 13 years long gap. The scrutiny from global regulators towards quality of the products coming from India has eventually derived CDSCO to conduct such inspections. In the wake of sudden increase in the number of Form 483 (issued for non-compliance by FDA) ,Indian regulators are concerned regarding the quality and manufacturing processes followed at Indian manufacturing sites.

Drug Controller General of India Dr G N Singh states that “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,”.

The inspections will be done based on the location and overall performance of the lab, he further adds.

The National Accreditation Board for Testing and Calibration Laboratories (NABL) is deemed to certify laboratories for testing drugs and cosmetics. 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.

UK“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 laboratorypractices (GLP).

There are not enough NABL-accredited labs for conducting frequent and regular tests. However, the record of regular audit of these labs is not sufficient and incomplete.

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