Mumbai: FDA finds defect in entire injection batch after patient dies at Saifee hospital

The medical staff of Saifee Hospital in Mumbai and 11 pharma centers in Thane, Pune, Aurangabad, and Delhi were booked for using unauthorized injections after a patient died of side effects in Mumbai.

Mumbai: A patient's death due to a defective injection at the Saifee hospital here has stirred the medical circle in and around Mumbai. An initial investigation into the matter revealed that the entire batch of an FCM injection -- which is used to treat iron deficiency in blood -- was fake and unauthenticated. Taking cognizance of the matter, the Food and Drug Administration (FDA) drug inspector Rajesh Bankar on Saturday registered a case against the medical staff of Saifi Hospital along with 11 pharma centers in Thane, Pune, Aurangabad, and Delhi.

As informed by the police, the deceased identified as Vivek Kamble was receiving treatment at the Saifee Hospital on Charni road for a deficiency of red blood cells in his body. The doctors here treated him with an 'Orofer' injection as a part of treatment. Kamble soon started experiencing side effects of the injection, and eventually on October 12 died because of it. His family reached out to the FDA to lodge a complaint in the matter.

The FDA soon launched an investigation on November 10, wherein the FDA officials inspected the hospital's stockpile of Orofer injections and confiscated it. Some samples of these seized injections were sent by the FDA to a laboratory in Samrudh Pharmaceutical Private Limited at Tarapur in Palghar.

After the test report revealed that the seized drugs had fake labels, the FDA filed a complaint at the VP Road Police Station. Senior Police Inspector Kishore Shinde from the VP Road Police Station said that a case has been registered against the medical staff and suspected pharma stores under sections of cheating, forgery, breach of trust, making or possessing counterfeit seal, etc under the IPC as well as sections under the Drugs and Cosmetic Act, and a further investigation is underway.