Maha FDA to inspect factory premise of Centaur Pharma for WHO-GMP violation

Shardul Nautiyal, MumbaiWednesday, January 11, 2017, 08:00 Hrs  [IST]

Maharashtra Food and Drug Administration (FDA) will soon start inspections at Centaur Pharmaceuticals Pvt Ltd following Thane anti narcotics cell seizure of 140kg of Alprazolam worth Rs. 19 crore in a raid at its Ambernath unit.

According to official reports, 754 kg of drugs were seized in total, samples of which have been sent to the forensic laboratory as anti-narcotics officials are unsure about their nature.

Says a senior FDA official, “We are awaiting reports from the anti-narcotics cell and plan to inspect the Ambernath unit to seek details on WHO-GMP violations. The company had licences to produce 27 drugs but produced over 50 drugs including controlled substances.”

Centaur produces API, formulations and provides contract research and manufacturing services, clinical research, R&D, regulatory and marketing. The company exports to 96 countries across five continents and 42 per cent of company’s sales accrue from international markets.

This comes close on the heels of Maharashtra FDA plans to detect spurious drugs in all the 390 WHO-GMP certified manufacturing units in the state following a recent finding of spurious drug manufacturing 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.

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.

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.  It has observed that drugs are often mislabeled or fake 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.

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 firm violated rules in terms of selling or exporting injection 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.

Maharashtra FDA has appealed to citizens to share information regarding such clandestine activity with the state FDA. The citizens can mail information at 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. The firm is a WHO-GMP certified unit and is leading exporter to several countries.