As a part of its investigation related to the illegal stocking and supplying of prescription drugs and narcotics in the open market, Maharashtra Food and Drug Administration (FDA) has 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.

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.

Maharashtra FDA in a joint operation with the Thane police department is investigating to know the actual value of products which have been seized and other vital leads in the case. “If any discrepancy in accounting is found, the company may face relevant penalties under D&C Act and GMP violations based on the notice served, as per a senior FDA official.

Centaur produces API, formulations and provides contract research and manufacturing services, clinical research, R&D, regulatory and marketing.

When contacted, spokesperson of Centaur Pharmaceuticals said, “We have received the show cause notice from the state FDA and are in the process of filing the replies in due course of time."

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.