Centaur Pharmaceuticals Pvt Ltd has replied to the show cause notice issued by Maharashtra Food and Drug Administration (FDA), Thane as a part of its investigation related to the illegal stocking and supplying of prescription drugs and narcotics.
According to spokesperson from the company, “We have complied with all the deficiencies pointed out in the show cause notice issued to us by Maharashtra FDA, Thane. The total traceability of the production has also been established.”
Around 140 kg of anti-anxiety drug alprazolam worth Rs.19 crore was seized by Thane police anti narcotics cell during a raid at Centaur Pharmaceuticals Ambernath unit in January this year. Thane police anti narcotics cell seized 754 kg of drugs in total.
Following which, Maharashtra FDA had served a show cause notice to Centaur Pharmaceuticals Pvt Ltd, which exports to 96 countries across five continents and 42 per cent of company’s sales accrue from international markets. The company is approved by US FDA, ANSM, TGA, AFM JAPAN, COFEPRIS, ANVISA, KFDA and it is a WHO-GMP approved plant.
It is also certified by ISO 9001:2008 / ISO 14001:2004/BS AND OHSAS 18001:2007. Over 85% of its production is exported and balance 15% is purchased by domestic companies for formulating for exports.
Maharashtra FDA in a joint operation with the Thane police department is currently investigating to know the actual value of products which have been seized and other vital leads in the case.
Centaur produces API, formulations and provides contract research and manufacturing services, clinical research, R&D, regulatory and marketing.
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 licenses of which have also been canceled.
Around 12 pharma manufacturers have also 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.
Maharashtra FDA had in the past issued show cause notice to a Nashik based firm also for not complying to quality control protocols and GMPs. The firm is a WHO-GMP certified unit and is leading exporter to several countries.
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.