The drug authorities have filed a case against Shree Vinayak Trading company, Mumbai for selling spurious Iviglob Ex. Injection, manufactured by Hualan Biologicals of China. The injection was imported and marketed by VHB Lifesciences Ltd, Mumbai.

According to Deputy Drugs Controller (CDSCO, West Zone), Shree Vinayak Trading company, Rajiv Industrial Co-op Society Ltd, Unit No.7-A, T J Road, Sewree (West), Mumbai-400015, was involved with spurious drug Iviglob Ex (Normal immunoglobulin for intravenous use BP (Human), 5 gm per 100 ml, B.No.200806010, exp date 31.5.2011 purported to be imported and marketed by M/VHB Life Sciences Ltd., Mumbai.

A team of drug inspectors from CDSCO and FDA, Maharashtra first visited the premises of Shree Vinayak Trading Co on 24.08.09 and started the investigation.

During the inspection of Shree Vinayak Trading Co., it was found that they have not maintained /kept the hard copies of sale bills of IVIGLOB Ex inj and the data of sale and purchase was found deleted from the computer and the data fabricated. As per the direction, of Joint Commissioner (Vigilance), the FIR against the power of attorney holder Umesh Shah and Bharat Shah along with other related persons were registered at RAK Marg Police Station (FIR No.252/09).

Police seized the hard disk along with the computer and one bottle of Iviglob Ex inj., having Batch no.200806010 and arrested Umesh Shah. Another accused Bharat Shah applied for anticipatory bail and is still absconding. Hard disk of the computer was sent to Forensic Lab. Samples are also sent for test from the seized stock and reports are awaited.

The price printed on the label is Rs 18990 MRP inclusive of all taxes. As per the available data it is found that around 324 x 100 ml ( appx. value Rs 61 Lakhs) vials of spurious Iviglob Ex inj. was distributed by Shree Vinayak trading co. The total value may increase after the retrieval of the data from CPU by Forensic Lab.

The comparison of the stock sold by Shree Vinayak Trading Co. with that of stock imported VHB Lifesciences, Mumbai revealed that the stock sold by Vinayak T Trading Co. is of spurious in nature.

Further, on investigation it is found that the vial of spurious Iviglob EX. Inj., is identical and resembles to the immunoglobulin inj. Elgam, which is officially imported by EL-SHADAI Biologicals Ltd., Chennai-34. Shree Vinayak Trading Co. is also an agent of the said firm M/s.EL-Shadai. It is suspected that Shree Vinayak Trading Co had changed the labels of EL-GAM inj with Iviglob Ex inj. as there is huge price difference between the two brands and the Iviglob Ex brand is moving fast in the market with huge field force employed by M/sVHB Lifesciences Ltd.

Further investigations are on.