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.