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Diagnostic kits cleared by testing agency despite ban


Times of India reports;


In a regulatory lapse that might have cost the lives of innumerable patients, National Institute of Biologicals (NIB) was found to have cleared over 300 batches of blood products and diagnostic kits in 2007-08 despite a ban imposed on the testing agency by the health ministry due to ‘‘large-scale irregularities’’. Comptroller and Auditor General (CAG) also found that over 80% of those samples had been received by NIB from Reliance Life Sciences (RLS).

Though the CAG report on the Rs 256-crore NIB, tabled in Parliament on Friday, did not name RLS, TOI has unearthed the identity of the biggest beneficiary of the lax drug regulation from sources in the ministry. The CAG report simply said that most of the samples received by NIB after it had been banned in July 2007 ‘‘belonged to one particular manufacturer/company’’.

 In its response to audit recommendations, the ministry confirmed five months ago that out of the 316 samples received by NIB’s blood products laboratory in the year following the ban, ‘‘88% were from a single manufacturer’’. The ministry also claimed to have initiated internal inquiries in the drug control set-up and Noida-based NIB to find out how so many samples had come to be tested and cleared without authority. CAG on its part recommended that the ministry should strengthen its oversight mechanism to ensure compliance of its instructions by NIB and the drug regulatory system.

 RLS spokesperson told TOI that the company could not be blamed for the violation of the ban by NIB. ‘‘None of the samples were sent directly by RLS to NIB,’’ he said. ‘‘They were all sent as per the procedure through Mumbai’s deputy drug controller.’’ Not surprisingly, the spokesperson took refuge in the fact that NIB had during the period in question tested samples, however few, of other manufacturers as well.

More seriously, NIB was found to have violated not only the ban but also the very procedure of testing the quality of biological products used for advanced medical care. In the case of life-saving drugs like albumin and immunoglobulin, NIB issued ‘‘batch release certification’’ by conducting barely half of the 19 prescribed tests. ‘‘Thus, instead of becoming an instrument for preventing distribution of substandard products in the country, issue of certificates by NIB without proper testing entailed a risk of NIB becoming a conduit of distribution of substandard products,’’ CAG observed.

Among its other regulatory lapses, NIB delayed the clearance of diagnostic kits for HIV and hepatitis C for so long that some batches were cleared two to eight days before their dates of expiry. CAG also took serious note of instances of biological products of Chinese origin being cleared by NIB without conducting the necessary tests and without even checking the antecedents of the manufacturers.



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