Diagnostic Update

High Court Dismisses PIL Against Span Diagnostics

Span has supplied approximately 30 millions tests through various Government programmes

View of Span Diagnostic, Surat

The Delhi High Court has recently dismissed a petition that alleged discrepancies in the procurement of test kits for HIV detection from Surat-based Span Diagnostics Limited. The PIL, filed by NGO, ADHIKAR in August 2007 against UOI and five others including Span Diagnostics Ltd had alleged that some of the kits supplied to National Aids Control Organisation (NACO) under award IFB-39 dated October 27, 2006 were faulty and unreliable.

The division bench consisting of Chief Justice AP Shah and Honourable Justice Manmohan J, in their order dated August 26, 2009, dismissed a petition stating, "Nothing survives in the petition; the allegation of a financial scam is not substantiated."

Taking cognizance of the arguments, the High Court order referred to the malicious intent of a disgruntled competitor who had unsuccessfully bid for a tender floated by NACO for the supply of test kits for HIV detection. A section of the media had then reported an alleged "financial scam in the procurement of test kits".

Reacting to the High Court order, Paras Desai, Founder Chairman, Span Diagnostic, said, "Once again, Span's undeterred focus to ensure quality at every stage has been upheld. It increases pride and satisfaction for all our people. We are committed to ensure customer satisfaction, employ ethical means in whatever we do and follow the vision of offering reliable and affordable diagnostic tools to maintain market leadership in our industry segment of medical diagnostic kits and reagents."

"The respondents to the petition -Span — represented by senior counsel, KV Vishwanathan, submitted that the company's test kit manufacturing facilities were duly licensed by the Indian Drug Control authorities, compliant with good manufacturing practices in accordance to Indian and WHO guidelines. Before dispatching, the entire consignment of 63 lakh tests had been inspected by an independent inspector and representative sample kits from each batch were tested in the Government laboratory and certified for distribution by Hindustan Latex Limited, a procurement agency of NACO," said Desai.

Nevertheless, acting on a complaint, the Chattisgarh State Aids Control Society wrote to NACO that test kits pertaining to a certain Batch Number 9180 was substandard. "This was promptly followed by Span deputing their technical representatives to demonstrate the successful and satisfactory performance of the alleged faulty test kits. Also, certificates disproving the allegations were obtained from the laboratories concerned, although as a mark of goodwill, Span replaced all the alleged "faulty" test kits belonging to Batch Number 9180," added Desai.

Admitting a PIL, however, the Delhi High Court issued notice to relevant authorities, as a result of which, in turn, the Gujarat State FDA sent a Show Cause Notice to Span. Consequently, the Drug Inspector, Food and Drug Control (Administration) sent samples of test kits of Batch Number 9180 and a few other samples drawn at random to Pune's National Aids Research Institute (NARI) for evaluation. The NARI reports confirmed that the performance of the sample test kits was "100 per cent satisfactory". The petition was therefore dismissed.

Span has been offering its product to the NACO programme for several years and has, till date, supplied approximately 30 millions tests through various Government programmes.

EH News Bureau