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The Maharashtra Food and Drug Administration (FDA) has detected a Navi Mumbai-based firm for not complying to provisions of Schedule L 1 and Schedule M regarding Good Manufacturing Practices (GMP) of Drugs and Cosmetics Act 1940 and Rule thereunder.
Sanjivani Parentrals Ltd is a WHO-GMP certified company, performing export of injectables in huge quantities and not following mandatory statutory provisions. Products manufactured under such conditions may lead to harm the export and economic interest of the pharmaceutical business of Maharashtra and ultimately of India.
In November 2016, 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.
Major findings of the inspection are that the firm has sold and exported injection Kocef 1 gm product on 22 November 2016 before completion of analysis and without mandatory entries. It has manufactured batch of Kocef 1 gm in the absence of approved competent technical staff and had maintained false entries regarding presence of staff in documents.
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 has 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.
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