Health ministry has set a deadline of November 15 for self assessment of drug regulators as a part of Central Drugs Standard Control Organisation (CDSCO) new draft checklist and evaluation tool released recently aimed at streamlining uniform inspection procedures across the country related to good manufacturing practices (GMP).
The checklist and tool will 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 to be carried out jointly by the CDSCO officials and Drug Inspectors of the States concerned.
CDSCO has developed a draft checklist and an 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.
A new draft checklist check list was released on August 23 for the state drug regulators to ensure that there is uniformity of inspections across all the Schedule M units in the country. This is also in line with CDSCO's plans to bring about uniformity in inspections of Schedule M units across the country as a part of its programme to upgrade Schedule M units to WHO-GMP level.
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. CDSCO has started imparting training to drug regulators and analysts from state and central governments for inspection of manufacturing units with respect to GMP and GLP based on the components of this document.
This will be 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 being evolved around the learning from global regulatory counterparts on current good manufacturing practices (cGMP) which will help manufacturers in adopting global GMP practices.
CDSCO plans to increase audits in the manufacturing units across the country towards compliance to GMP as per the requirements of the respective markets globally.
To tackle lapses in manufacturing compliance, CDSCO has developed the new system to guide inspections and burnish India’s GMP image.
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.
Growing number of audits are going to be taken up by global agencies worldwide in future with global regulators hiring drug inspectors for auditing sites in respective countries of engagement and operations for GMP compliance.