Maharashtra FDA Cancels Skyline Impex Licences After Alleged Spurious Peptide Export

Swedish customer Tommy Blomqvist had reportedly placed an order for MOTS-c and other products described as “research peptides” from Skyline Impex through the IndiaMART platform. Subsequent laboratory analysis of one of the samples allegedly found no detectable active substance in the product.

During its investigation, the FDA reportedly found that the products carried branding linked to US-based Peptide Sciences, USA. When contacted, the American company allegedly confirmed that the labels and product artwork being used were counterfeit and had not been issued by it.

An inspection of Skyline Impex conducted by FDA officials on June 25 reportedly led to the discovery of fabricated Certificates of Analysis (CoAs) and counterfeit label designs stored on the firm’s computer systems.

The disputed labels also allegedly contained QR codes that redirected customers to the official website of the genuine foreign company. Investigators suspect that these QR codes were used to create a false impression that the products were authentic.

During the inspection, FDA officials reportedly recovered approximately 2,000 vials of Bacteriostatic Water for Injection carrying the marking “For Export Only.”

Samples collected from two batches of the product were later examined at a government laboratory and declared Not of Standard Quality. The samples reportedly failed to comply with prescribed parameters for bacterial endotoxins, pH and particulate matter.

The police have booked Yash Sevendra Berry, a resident of Jaripatka and partner in Skyline Impex, along with Manhir Singh of Zirakpur, Punjab, who has been identified as an alleged supplier. The purported manufacturer, M/s Dr Glexx Pharmakem, and other unidentified persons have also been named in the case.

The FIR has been registered under Sections 318(4), 336(3), 338, 340(2), 276, 277, 278, 61(2) and 3(5) of the Bharatiya Nyaya Sanhita (BNS).

The investigation has also raised allegations of under-invoicing and manipulation of shipping documents relating to the consignment reportedly exported to Sweden.

Following the findings of the investigation, the Maharashtra FDA cancelled the wholesale drug licenses held by Skyline Impex, Nagpur Today reports.

The police and FDA are continuing their investigation into the alleged manufacture and supply of spurious drugs, use of counterfeit labels, fabrication of quality certificates, and manipulation of export-related documentation.