Mumbai :Against the backdrop of recent spurt in cases of non-compliance to good manufacturing practices (GMP), Maharashtra Food and Drug Administration (FDA) is planning to take action on two more manufacturers for non-compliance to GMP norms following cancellations of WHO GMP Certificate of two Maharashtra based WHO-GMP units - BDH Industries Limited, Mumbai and Sydler Remedies Pvt Limited, Pune.
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.
The recent actions were taken 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.
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. Accordingly, under guidance of FDA Commissioner Dr Harshdeep Kamble and Harish Baijal, Joint Commissioner, Vigilance, an FDA team inspected the factory premises at Rabale, Navi Mumbai.
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 has violated 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. The label claims stated on various manufactured drugs were not in accordance with the formula approved by the 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.
Harish Baijal, Maharashtra FDA Joint Commissioner, Vigilance, has also 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.
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.
Maha fda plans massive crackdown, who gmp pharma units for gmp violations
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