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DCGI mandates risk-based inspections for all Sch M units as grant of licenses becomes valid forever
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Shardul Nautiyal, Mumbai
November 14 , 2017
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The Drug Controller General of India (DCGI) has mandated risk-based
inspections for all the Schedule M units in the country following
notification for grant of licenses till perpetuity.
The Union
health ministry had recently notified Drugs and Cosmetics (Tenth
Amendment) Rules, 2017 doing away with renewal of licences for the
manufacture, sale and distribution of pharmaceutical products every five
years.
“These risk-based inspections are meant to ensure that
drug makers comply with GMP notwithstanding the fact that there is now
no need to renew license every five years. Non-compliance to GMP would
immediately attract strict penalties under the law and even
cancellations based on the severity of the case,” said DCGI Dr G N
Singh.
The notification which is effective from October 27, 2017
says manufacturing and sale of licences, once issued, shall remain valid
forever unless suspended or cancelled by the licensing authority. The
relevant rules have been amended for this purpose.
Risk-based
inspections are based on a checklist issued for the state drug
regulators aimed at streamlining uniform inspection procedures across
the country related to GMP. CDSCO recently concluded 185 risk-based
inspections in 8 phases based on a checklist issued for the state drug
regulators and will soon roll out another phase of risk-based
inspections.
The checklist and tool is meant to help CDSCO and
state drug regulators to 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 state drug
controllers concerned.
“A mechanism to do self auditing by manufacturers has also been devised to check the compliance levels,” Dr Singh concluded.
The
Union health ministry is also in the final stages to release a draft
guideline towards enhancement of GMP to align India-specific standards
with global regulations for better product quality of pharmaceutical
products.
As per the new notification, an inspection of drug
manufacturing plants will be conducted by both central and state
inspectors every three years to verify compliance with the conditions of
licence and provisions of the Drugs and Cosmetics Act, 1940. The
manufacturers will have to inform the regulator and apply for a
no-objection certificate in case of any minor or major changes made by
them in their unit.
Aimed at enhancing ease of doing business in
India, government amended rules for manufacturers to grant licenses that
will remain valid as long as they comply with GMP.
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