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Big pharma houses under the radar
Prominent pharma manufacturing companies of the State are under the Drugs Control Association (DCA) radar for production of poor quality anticancer drugs. The DCA received complaints that the anticancer drug ‘Vincristine’ imported from China is of poor quality and that some of important companies were using this as an Active Pharmaceutical Ingredients (API) in their units Based on this information
Prominent pharma manufacturing companies of the State are under the Drugs Control Association (DCA) radar for production of poor quality anticancer drugs. The DCA received complaints that the anticancer drug ‘Vincristine’ imported from China is of poor quality and that some of important companies were using this as an Active Pharmaceutical Ingredients (API) in their units Based on this information, checks were conducted on February 17 and 18 by 12 teams of regulators from DCA on prominent anti cancer manufacturing firms.
The firms under the radar are Hetero Labs Ltd. at Kazipally and Jadcherla, Dr Reddy Labs Ltd, FTO at Bolarum, Dr Reddy Labs Ltd, CTO at Bolarum, Natco Pharma Ltd at Kothur and Nagarjuna Sagar, MSN Labs Ltd at Shameerpet, Shilpa Medicare at Jadcherla, Laurus Labs Ltd at Shameerpet, Accura Labs at Shameerpet, Celon Labs, ALEAP at Gajularamaram and Therdose Formulations, ALEAP at Gajularamaram.
Five samples of the drug have been picked up and are being sent to the Central Drug Laboratory in Kolkata for analysis. The shortcomings noted are failure to stock bulk drugs as per label conditions, failure to conduct audit trials for HPLC (laboratory equipment),
purchase of APIs from unapproved vendors, non maintancence of Analytical reports, stocking Anti Cancer drugs along with excipients instead of storing them separately, discrepancies regarding reconciliation of printed labels and no provision of biosafety cabin for testing cytotoxic APIs in laboratory.
