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Two pharma cos seek fresh WHO-GMP certifications after state FDA canceled their licenses
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Our Bureau, Mumbai
April 03 , 2017
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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.
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