DCA conducts check on anti-cancer drug manufacturing units Hyderabad, Feb 18 (INN): Following reports that anti-cancer drug 'Vincristine' imported from China was of poor quality, the Drugs Control Administration conducted checks on 12 companies who are using 'Vincristine' as an Active Pharmaceutical Ingredients in their units.
As many as 12 teams of regulators from DCA conducted checks on the anti-cancer manufacturing firms including M/s.Hetero Labs, M/s.Dr.Reddy Labs, M/s.Dr.Reddy Labs, M/s. Natco Pharma, M/s. MSN Labs, M/s.Shilpa Medicare, M/s.Laurus Labs, M/s.SP Accura Labs, M/s.Celon Labs and M/s.Therdose Formulations. (INN)
Five samples of the drug have been picked up and these will be sent to Central Drug Laboratory, Kolkata for analysis, said DCA Chief Akun Sabharwal.
During checks it was found that some of the manufacturing firms failed to stock bulk drugs as per label conditions. They also failed to conduct audit trials for HPLC (laboratory equipment) and a few of them purchased APIs from unapproved vendors. Other shortcomings noticed include not-maintenance of Analytical reports; stocking of Anti Cancer drugs along with excipients instead of storing them separately; Discrepancies in reconciliation of printed labels and non-provision of biosafety cabin for testing cytotoxic APIs in laboratory.
News Posted: 18 February, 2016
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