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CDSCO soon to begin inspections on drug testing labs to ensure compliance of D&C Rules
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Shardul Nautiyal, Mumbai
November 10 , 2017
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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.
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