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Times of India
15 March 2010
By Virat a Singh

Sewree firm found supplying cheap version of expensive drug used to boost immunity in terminally ill patients
FDA suspects that fake labels of IVIGLOB EX could have been pasted on El-Gam bottles FDA suspects that fake labels of IVIGLOB EX could have been pasted on El-Gam bottles
Acity-based firm has been selling bottles of a spurious life-saving drug used by AIDS and cancer patients to medical stores in Mumbai and other parts of the country.

Food and Drug Administration investigators said that Shree Vinayak Trading Company, based in Sewree, has been selling bottles of injectable solutions marked as IVIGLOB-EX. The medicines are imported by VHB Life Sciences, and Shree Vinayak is the distributor. IVIGLOB-EX injections are expensive – a 100-ml bottle costs Rs 18,990 – and are used to increase immunity in terminally ill AIDS and cancer patients. The bottles seized by FDA from Shree Vinayak were, however, similar to those of EL-Gam injections – another brand with similar ingredients as that of IVIGLOB-EX, but cheaper at Rs 14,490.

During investigations, FDA found that even medical stores near reputed hospitals were selling IVIGLOB-EX, which were not identical to the imported ones. The chemical composition in seized samples were similar to that in the standard preparation. “But the company was selling a cheaper version under a different brand name to boost profits. However, reports on the tests are still awaited,” said an official.

An FDA team, including drug inspectors R Tirpude and R Choudhari, raided Shree Vinayak and seized 24 bottles. They also found that over 300 bottles valued at Rs 65 lakh had been distributed by Shree Vinayak. An official said that under directions of IPS officer R K Sahay, joint commissioner (vigilance), they raided the Sewree firm. “However, employees destroyed sales bills and those found on computer were fabricated,” the official said. The computer hard disk has been seized and sent for data recovery.

FDA registered an FIR with the RAK Marg police against two people from Shree Vinayak. While one was in police custody and later released on bail, the other obtained anticipatory bail.

Senior Police Inspector Popat Tiwatane of RAK police said, “Investigations are on. We are awaiting chemical analysis of samples.” Sources, however, said the accused have not disclosed the source of the spurious drug or the manufacturing process. FDA suspects that fake labels of IVIGLOB EX could have been pasted on El-Gam bottles and later packed in cartons of IVIGLOB-EX. Meanwhile, FDA officials have informed VHB Life Sciences about the case. Neither VHB nor Shree Vinayak could be contacted for comments.

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