The Drugs Control Administration (DCA) of Telangana has inspected 12 units of major pharma firms, including Dr Reddy’s Laboratories, Hetero Drugs and Natco Pharma, following complaints that a Chinese anti-cancer active pharmaceutical ingredient, used by these companies, was of poor quality.
“We received complaints that anti-cancer drug ‘Vincristine’ imported from China was of poor quality. Some companies were using this as an active pharmaceutical ingredient in their units,” Akun Sabharwal, Director, DCA said in a statement.
“Some of the important companies were using this as an active pharmaceutical ingredients (APIs) in their units. Based on this information, checks were conducted on 17th and 18th February, 2016 by 12 teams of regulators from DCA on the following anti-cancer manufacturing firms which include Hetero Labs Ltd, Hetero Labs Ltd, Dr. Reddy’s Labs Ltd, Natco Pharma Ltd, MSN Labs Ltd, Shilpa Medicare, Laurus Labs Ltd, SP Accura Labs, Celon Labs and Therdose Formulations.”
The DCA said that five samples of the drug have been picked up and these will be sent to Central Drug Laboratory, Kolkata for analysis.
Some of the shortcomings which were noted include that some of the manufacturing firms failed to stock bulk drugs as per label conditions, failed to conduct audit trials for HPLC (laboratory equipment), purchased APIs from unapproved vendors, not maintaining analytical reports, stocked anti-cancer drugs along with excipients instead of storing them separately, discrepancy was observed regarding reconciliation of printed labels, not provided biosafety cabin for testing cytotoxic APIs in laboratory.