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Spurious drug case: Accused gets bail as drugs control officer did not get permission to visit Italy
Additional sessions judge (ASJ), Gurugram, Jasbir Singh while granting bail to accused Motidur Rahman Ansari said that the DCO has mainly relied upon an email sent by the manufacturer to establish the spurious nature of the drug seized from co-accused Sandeep Bhui.
With the Haryana government not granting permission to Gurugram drugs control officer (DCO) to visit Italy for authenticating the credentials of an alleged spurious drug, Defitelio infusion concentrate, administered intravenously to cancer patients, a Gurugram court has granted bail to an accused in the case.
Additional sessions judge (ASJ), Gurugram, Jasbir Singh while granting bail to accused Motidur Rahman Ansari said that the DCO has mainly relied upon an email sent by the manufacturer to establish the spurious nature of the drug seized from co-accused Sandeep Bhui.
The manufacturer in an email, the court said, informed that the product is not authentic, and the World Health Organisation (WHO) has issued an alert in this regard.
The court said that the record of Italy-based manufacturer of Defitelio, Gentium SRL was not verified by the DCO. “For the purpose of verification, the drugs control officer sought permission from commissioner, Food and Drugs Administration, for getting the sample tested from the manufacturer, get the label analysed with the original label, get the original label and serial number verified from the manufacturer and verify the supply chain,” the court said.
The ASJ said that it has also been mentioned in a letter that under these circumstances, there was no other way to collect evidence to prove the case. “Admittedly, the said permission was not granted to the drugs control officer and the record of the manufacturer has not been verified to establish whether the seized drug from co-accused Bhui has been manufactured by Gentium SRL of Italy or not,” the court said.
The ASJ said that merely on the basis of an email received from the manufacturer, it cannot be inferred whether or not the drug seized from co-accused Bhui was a genuine product or not. “The question as to whether the drug seized from co-accused Bhui is truly a product of the manufacturer of whom it is purported to be is a subject of trial. As such, the culpability of Ansari is yet to be tested during the course of trial,” the court said.
The Gurugram drugs control officer had in April arrested a Delhi resident for allegedly selling spurious Defitelio to a Panipat resident admitted in a Gurugram hospital.
Panipat resident Rohit Kansal had given a complaint that vials of Defitelio infusion concentrate supplied by Delhi resident, Bhui was spurious. Kansal said that 10 vials were supplied for his brother, a cancer patient getting treatment at a private hospital in Gurugram for ₹2.5 lakh.
Investigations by the drugs control officer revealed that Bhui was neither able to produce the sale invoice of the product nor a valid retail sale drug licence as required under the law.
An email was sent by the DCO to Italy-based Gentium SRL, the manufacturer of Difitelio infusion concentrate to verify the credentials of vials. In its response, head of quality, Gentium SRL, Manuela Camisa wrote that Defitelio (batch number 19G19A) reported by the Haryana FDA is not an authentic batch and should not be used. “The same batch was identified in the UAE in November 2022 and was offered in March 2023 in Kyrgyzstan. This was notified to WHO and a rapid medical alert was issued on their website,” Camisa wrote.
Bhui on being interrogated told the police and the FDA that the injections were supplied to him by one MR Ansari of Delhi, the police had said. Ansari, who surrendered before the FDA, Gurugram, on April 28, told officials that he had procured injections from Noida-based Heartland Pharmacy (OPC) Pvt Ltd.
The court said since Ansari himself surrendered before the DCO, made a disclosure statement and did not flee; the court is of the opinion that the accused is not likely to commit any such offence while on bail.
