In a rare incident of its kind, the Drug Controller General of India (DCGI)'s order of suspending a drug on public interest has been stayed by the Union Health Ministry. The ministry has stayed the order of the DCGI to suspend the sale of Hyderabad-based Natco Pharma's breast cancer drug paclitaxal injection (Albupax).
Following the detection of not of standard quality, the DCGI had on July 16, 2009 vide letter No. QA/GNL/BCN/INV-ABR directed in public interest to M/s. Natco Pharma Ltd, Hyderabad, AP to recall the breast cancer drugs paclitaxal injection (Albupax) Batch No. 202013 and 202119 manufactured by them. The DCGI's action was based on the report of the Central Drugs Laboratory, Kolkata which found that the samples were not up to the mark.
“The director, Central Drugs Laboratory, Kolkata vide letter no. 32-10/2009-SS/1049 dated 13-07-2009 informed that said batches of paclitaxal injection (Albupax) were found to be not of standard quality for the reason that “Sample does not confirm to manufacturers specification with respect to Endotoxin test,” the report had said.
Subsequently new drug permission granted to Natco Pharma in respect of breast cancer drugs was suspended vide letter No.QA/GNL/BCN/INV-ABR, dated 20/10/09 by DCGI Dr Surinder Singh.
The Natco Pharma, meanwhile, appealed to the higher authorities in the Union Health Ministry under section 84-A of the Drugs and Cosmetics Rules, 1945 which allows an aggrieved party to go 'for appeal to the state government or central government by party whose license has not been granted or renewed'.
In the appeal, the Health Ministry stayed the order of DCGI.