The controversial Natco issue, involving suspension and subsequent revocation of the permission to Natco Pharma's breast cancer drug Albupax's by senior health ministry officials last year, will be echoed in Parliament as the matter caught the attention of the law makers.
According to sources, the Natco issue will come up for discussion in the ongoing session of Parliament as a starred question as some Parliamentarians have taken up the issue. The Natco issue became controversial when the DCGI order of suspending the Natco Pharma's breast cancer drug Paclitaxal injection (Albupax) was stayed by the senior officials in the Union Health Ministry. The suspension and its subsequent revocation in a short span of time left an imprint among the public as well as the law makers that senior health ministry officials are working at cross purposes.
The drug controller general of India (DCGI) Dr Surinder Singh in October last year had suspended the new drug permission granted to Natco Pharma's breast cancer drug Paclitaxal injection (Albupax) on concerns of quality of the drug. But, about two months later in December, 2009, the newly appointed secretary in the union health ministry Sujata Rao stayed the DCGI order.
It was considered a rare incident of its kind, as the DCGI is the highest authority in regulating the safety and quality of medicines in the country, and it was a general practice that his opinion on quality and safety of drugs is final. That he consults the DTAB on technical matters is another issue. But the revocation of his order in the Natco's case left a bad taste among the public.
The Natco case dates back to July last year when 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 Natco Pharma Ltd, Hyderabad, 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 "Samples 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.