The Maharashtra Food and Drug Administration (FDA) is planning to serve show cause notice to Centaur Pharmaceuticals as a part of its investigation related to the illegal stocking and supplying of prescription drugs and narcotics in the open market.

This is following the seizure of 140 kg of anti-anxiety drug alprazolam worth Rs.19 crore by Thane police anti narcotics cell in a raid at Centaur Pharmaceuticals Ambernath unit last month.

Maharashtra FDA in collaboration with the Thane police department is also assessing the actual value of the products which have earlier been seized following which a major inspection drive has been done by the state regulator at Centaur Pharmaceuticals Ambernath unit.

As per police records, Thane police anti narcotics cell seized 754 kg of drugs in total, samples of which have been sent to the forensic laboratory.

It is also being assessed whether the company was directly or indirectly involved in the narcotics drug haul case and to verify the facts that the drugs produced were actually accounted for. If any discrepancy in accounting is found, the company may face relevant penalties under D&C Act and GMP violations.

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.

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.

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.

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.

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.

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.