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The Central Drugs Standard Control Organisation (CDSCO) has successfully concluded 170 risk-based inspections to verify GMP compliance as per the provisions of Schedule M of Drugs and Cosmetics (D&C) Rules, 1945 since October 2015.
It was observed that around 170 manufacturing units were found to have committed repeated failures in terms of GMP compliance and quality issues based on the inspections done by the central drug regulator.
“This was subsequent to the findings by the government's pan India study done by National Institute of Biologicals (NIB) which revealed that percentage of not-of-standard quality (NSQ) was 10 to 12% in government supplies and 4% in retail supplies,” according to a CDSCO official.
As a part of the survey in 2015, the analysis was done through a specialised software which offered field data on spurious and NSQ drugs online on a consistent basis for facilitating the process of analysis and testing. This field data on drugs was sent online to Central Drug Testing Labs (CDTL) in Chandigarh, Mumbai, Hyderabad, Chennai, Kolkata and Guwahati for analysis and final report. Other State Drugs Testing Labs at Vadodara, Karnataka and at IPC, Ghaziabad were also a part of testing and analysis.
The central drug regulator had earlier concluded 185 risk based inspections in 2017 jointly with state drug controllers in 8 phases based on a checklist issued to the state 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.
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 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, describe the pest, insects, birds and rodents control system followed in the premises. It also mandates pest control schedule- area wise, along with materials and methods used in various parts of the premise (storage area, manufacturing area specially visual inspection, laboratory areas etc).
This checklist would be used by drug regulatory enforcement agencies as a science based tool. It is also envisaged that pharma industry would also find this checklist useful for self-assessment.
This is a big boost to several Indian drug makers which had come under the scanner of the global drug regulatory authorities in the recent years over a range of issues like data integrity, including production quality, sanitation standards and alleged data manipulation.
The current upgradation of WHO-GMP norms is also being evolved around the learning from global regulatory counterparts on current good manufacturing practices (cGMP) which will help manufacturers in adopting global GMP practices.
As per the WHO website, GMPs include factors such as sanitation and hygiene, qualification and validation, self-inspection, quality audits, suppliers’ audits, prevention of cross-contamination and bacterial contamination during production, training employees and personal hygiene.
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