Following Maharashtra Food and Drug Administration (FDA) license cancellations three months ago, Maharashtra based WHO-GMP units - BDH Industries Limited, Mumbai and Sydler Remedies Pvt Limited, Pune have applied for fresh WHO-GMP certifications to comply with the GMP norms to avoid facing further scrutiny from the regulators.
“The state FDA will undertake fresh joint inspections based on the applications filed by two companies recently. The companies will have to go through the same set of audits to get the certifications which will get the WHO-GMP compliant status for exporting to regulated markets,” according to an FDA official.
The state regulator had taken action against the companies on the basis of Technical Report Series (TRS) issued by World Health Organisation (WHO) as a part of its guidelines on auditing and verifying of compliance of WHO- GMP units.
Maharashtra FDA had also recently issued show cause notices to some firms for not complying to quality control protocols and good manufacturing practices (GMPs).
Show cause notices were served for contravening the provisions of Section 18 (c) Rule 74, 78(p) of the D&C Act and various provisions of Schedule M Part I and Schedule Ll.
Based on FDA inspections, it was observed that major contraventions included log book for equipment were not in place, hygrometers did not have water, environmental control were not validated periodically, vendor validation records were not produced during inspection, air condition and lights were not found in working condition, no temperature and humidity records were available, overhead and underground water tanks were not cleaned periodically.
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.
Meanwhile, seven drug companies in India with substantial exposure to the US market, have also disclosed over the last couple of months that some of their manufacturing facility inspections had reached successful closure, signaling resumption of supplies and new product filings to the US.
Four GMP compliance reports were issued to Indian companies in 2015 compared to an average of around eight in 2011 to 2014. Thirty per cent of quality related warning letters and less than five per cent drug recalls have also been attributed to Indian companies, according to official sources.
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.