Form 483s Issued Last Year Show Indian Companies Had High Level of Data Integrity issues

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Even as the Central Drugs Standard Control Organisation (CDSCO) is in the process of upgrading its GMP standards to meet the requirements of global regulatory markets, Form 483s issued last year to Indian manufacturing units had a high level of data integrity issues, pinpoint regulatory experts analysing the trends.
Regulators globally during their audit visits at Indian sites have issued in total 19 Form 483 last year as a part of their observations on data integrity with the latest made on March 3 on a leading Indian company.
The originality of the data was not ensured and maintained which according to experts has led to data integrity issues which ought to be done on a real time basis. This has led to falsification of data and manipulations.
Several Indian drug makers have 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.
Meanwhile, CDSCO as a part of its larger commitment towards harmonisation of global regulatory standards is on its way to increase audits in the manufacturing units across the country towards compliance to good manufacturing practices (GMP) as per the requirements of the respective markets globally.
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. A check list has also been finalised for the state drug regulators to ensure that there is uniformity of inspections across all the Schedule M units in the country.
Any product which does not comply with good manufacturing practices of overseas markets is being considered as adulterated and hence faces the chance of losing the market, a senior CDSCO official said emphasising the purpose of the inspection in the interest of patient safety at large.
“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,” explained a CDSCO official.
GMPs is based on a criteria involving 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 personnel.

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