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Shardul Nautiyal, Mumbai November 14 , 2017
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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