Question : BAN ON NIB

(a) whether the Government had imposed a ban on the National Institute of Biologicals (NIB) from testing blood products and diagnostic kits;

(b) if so, the details thereof alongwith the reasons therefor;

(c) whether samples of blood products and diagnostic kits were sent to NIB by the Central Drugs Standard Control Organisation (CDSCO), west zone despite the ban;

(d) if so, the details thereof indicating the names of the manufacturers of these products; and

(e) the action taken by the Government against the erring officials for the above lapses?

MINISTER OF THE STATE IN THE MINISTRY OF HEALTH & FAMILY WELFARE (SHRI GHULAM NABI AZAD)

(a) & (b): The office of Drug Controller General (India) [DCG(I)] had written on 18.07.2007 to the Port and Zonal offices of Central Drugs Standard Control Organisation (CDSCO) not to send the samples of Diagnostic kits and blood products to National Institute of Biologicals (NIB) for test till further orders. The Zonal Offices were, however, permitted to send samples for tests to NIB from 10.02.2009.

(c) to (e): The following samples were received by NIB from CDSCO (West Zone) between July, 2007 to February, 2009:

(i) Blood products:

(1) Reliance Life Sciences, Mumbai (274)

(2) Celestial Biologicals Ltd., Ahmedabad (14)

(3) Bharat Serums & Vaccines, Mumbai (2)

(ii) Diagnostic Kits: 3 kits were received from Span Diagnostics, Surat.

The DCG(I) has informed that the samples were forwarded because of the condition of the license issued under Drugs and Cosmetics Rules, 1945 to the manufacturer to send the samples to NIB for testing. Disciplinary proceedings had been taken against the then Director (NIB) for the alleged irregularities which took place in the Institute during his tenure. He was also repatriated to his parent office.