DCGI Starts Inspections Of Drug Testing Labs In Country After A Gap Of Over A Decade

Mumbai, 8 Jan 2018: Drug Controller General of India (DCGI) has started conducting joint inspections of drug testing labs across the country with respective state drug controllers after a gap of over a decade.

DCGI had earlier alerted the drug testing labs to verify and assess their compliance levels through a self- audit to ensure audit -readiness before an inspection. 

There are around 134 accredited drug testing labs across all the states in the country as of today. According to official records, Maharashtra has the highest number of 33 accredited labs followed by Tamil Nadu which has 21 labs, Gujarat and Andhra Pradesh which has 13 and 14 accredited labs respectively.  

CDSCO had 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. 

The Good Laboratory Practices (GLP), 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. 

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.

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. 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.

SOURCE : Pharmabiz