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DCGI to audit mfg sites of cos before giving approvals for new drugs
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Shardul Nautiyal, Mumbai
July 31 , 2017
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Drug Controller General of India (DCGI) has started auditing
manufacturing facilities in the country for stability studies and to
verify minimum requirements for product quality assurance before giving
final approvals for new drugs.
This is a major policy shift as
earlier Central Drugs Standard Control Organisation (CDSCO) inspections
were not carried out at manufacturing sites before giving approval for a
new drug in the country.
Generally, health ministry constituted
Subject Experts Committee (SEC), Technical Committee and Apex Committee
examine applications for clinical trials in India before giving
approval to the new drug. All of the studies are approved by the DCGI
before the final approval.
“Since we are giving relaxation in
clinical trials on a case-to-case basis, the preparedness for
manufacturing high quality medicines to be made available to the Indian
population need to be assured at the manufacturing facility. This will
happen when we have a robust system of auditing, engaging and knowing
the preparedness of the manufacturer,“ explains Drug Controller General
of India Dr G N Singh.
Basic purpose of the exercise is to
conform to the expectation of the regulators, ability to adhere to the
needs of science and focus on quality by ensuring that basic standards
of quality requirements are met.
He further adds, “These audits
are also required in cases where clinical trial waiver is given to the
manufacturer for a particular new drug or there is serious doubt about
quality of the drug based on surveillance. Meanwhile, risk based audits
are also going on to ensure patient safety by verification at the point
of production.”
CDSCO has, till date, successfully concluded 185
risk based inspections in 8 phases based on a checklist issued for the
state drug regulators to ensure that there is uniformity of inspections
across all the Schedule M units in the country.
CDSCO checklist
and evaluation is aimed at streamlining uniform inspection procedures
across the country related to good manufacturing practices (GMP). The
checklist and tool is meant to help CDSCO and state drug regulators
understand and collaborate which pharmaceutical and active
pharmaceutical ingredient (API) manufacturing sites have been inspected
and are found to be compliant. The inspections are planned and carried
out jointly by the CDSCO officials and Drug Inspectors of the States
concerned.
CDSCO has developed checklist and evaluation tool to
outline proper inspection procedures with a consistent nationwide
approach for the inspections to be carried out by CDSCO officials and
state regulators.
Specifications mentioned in the checklist
include specify whether the whole facility is separated, dedicated and
is not a part of any other non-drug facility, specify whether the
surroundings of manufacturing area is clean and as per the SOP
prescribed in this regard. (Mention the SOP nos.), describe the pest,
insects, birds and rodents control system followed in the premises.
Specify pest control schedule- area wise, along with materials and
methods used and specify the level maintained in various parts of the
premise (storage area, manufacturing area specially visual inspection,
laboratory areas etc).
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