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Maha FDA to initiate special drive for detecting spurious drugs in WHO-GMP units
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Shardul Nautiyal, Mumbai
December 31 , 2016
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Maharashtra Food and Drug Administration (FDA) is mulling over a plan to
detect cases of spurious drugs in all the 390 WHO-GMP certified
manufacturing units in the state following a recent finding of spurious
drugs in two Maharashtra based WHO-GMP units.
WHO GMP
Certificates of two Maharashtra based WHO-GMP units - BDH Industries
Limited, Mumbai and Sydler Remedies Pvt Limited, Pune were recently
cancelled for GMP violations.
Says Dr Harshdeep Kamble,
Maharashtra FDA Commissioner, “The state regulator is planning a major
drive to detect spurious drugs in the aftermath of rampant violations of
good manufacturing practices (GMPs) by drug manufacturers. Around 12
pharma manufacturers have been identified and investigations are going
on to ensure that there is no circulation of spurious drugs in domestic
market and outside the country. It was observed that the label claims
stated on various manufactured drugs are not in accordance with the
formula approved by the State Licensing Authority.
He further
explains, “Drugs are often mislabeled or fake when we are talking about
spurious drugs which is a major challenge confronting the drug
regulator. There are instances in which drugs are mixed with steroids
with no mention on the labels which is detrimental to patient safety.
There is also a challenge of sub-standard drugs in which deviations are
observed in terms of not having required quantity of drug of a specified
therapeutic category.”
GMPs are 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.
As a part of the crackdown, the
state regulator also recently detected a Navi Mumbai-based firm for not
complying to provisions of Schedule L 1 and Schedule M regarding GMP of
Drugs and Cosmetics Act 1940 and Rule thereunder.
The WHO-GMP
certified company was performing export of injectables in huge
quantities and not following mandatory statutory provisions.
Intelligence branch of Maharashtra FDA got information that the said
manufacturer is engaged in various clandestine operations like selling
of drug prior to testing and manufacturing drugs for export by deviation
in the compliance of GMPs. Inspection report revealed that the firm is
manufacturing various injectable drugs with contravention of provisions
of Drugs and Cosmetics Act 1940 and Rules 1945.
The firm violated
rules in terms of selling or exporting injection Kocef 1 gm before
final authorization of Quality Assurance. It has not carried out
calibration of equipments like weighing balance, manufacturing tank,
HVAC System, etc. and maintained false documentations. It has also not
labeled the various drugs as per formula approved by State Licensing
Authority.
Besides this, the firm had exported Capreomycin
injection 1 gm by extending the shelf life of finished product beyond
expiry of active ingredients added in it. The firm had manufactured
injectable product prior to the declaration of the pass results of the
raw material or active ingredients.
Maharashtra FDA has appealed
to citizens to share information regarding such clandestine activity
with the state FDA. The citizens can mail information at
pavigilancefda@gmail.com or on toll free number- 1800222365
Maharashtra
FDA had also recently issued show cause notice to a Nashik based firm
for not complying to quality control protocols and GMPs. It was found
during inspection that quality control officers were absent in the
second and third shift and that explosive solvents like lsopropyl
alcohol were stored in open space among other violations. The firm is a
WHO-GMP certified unit and is leading exporter to several countries.
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