Amphotericin B sample from city fails sterility test in FDA lab

Nagpur: A sample of antifungal medicine Amphotericin B emulsion (sold under the brand name ‘Ambibio E’) collected from Shree Medical and General Store, Wardha Road, by food and drugs administration (FDA) in June was declared as “not of standard quality” as it failed to comply with the specifications required for clearing the sterility test, as per the findings of the government analyst.
FDA had to withdraw Ambibio E injections bearing the batch number HIUP2103, after several mucormycosis patients started developing reactions after medication.
FDA Nagpur assistant commissioner PM Ballal said the drug inspector who had collected the sample (NV Lohakare) shall file a chargesheet before the court after the receipt of the prosecution order from the FDA joint commissioner. “The manufacturer is likely to face prosecution in the court of law under the Drugs and Cosmetics Act, 1940, as it is a case of sterility test failure,” said Ballal.
A sample of Amphotericin B injection manufactured by Jodas Expoim private limited under the brand name ‘AmphiJO’, collected from the pharmacist Anil Dindokar at Government Medical College and Sarvopchar Hospital in Akola, on July 1 was also found “not of standard quality” by FDA.
The government analyst had underlined the fact that the Amphotericin B content in the sample was less than the permissible limit, and that it also failed in particulate matter and clarity tests.
Amphotericin B emulsion was in high demand towards the end of second Covid wave, when fungal infection mucormycosis started surfacing at an alarming rate. In Nagpur district, 1,757 patients had suffered from mucormycosis and 178 have died due to the fungus till August 20. Around 1,398 patients had to go under the scalpel, and around 21 are still in hospitals.
Amid the crisis, the Amphotericin B emulsion of a particular brand and batch had triggered adverse reactions among patients.
The Ambibio E samples from the manufacturer Health Biotech Ltd were collected after FDA was alerted by a number of hospitals in the city about the mucormycosis patients’ suffering.
One of the patients nearly suffered a cardiac arrest and was revived by the alert medical team, shortly after this drug was administered.
FDA sources had then said that around 200 vials were distributed. Out of the total, around 42 vials had already been used. The rest of the vials were withdrawn from the hospitals by FDA. Samples from around 28 vials of this drug with the specific batch number were collected by the FDA’s drug inspector Lohakare before being sent to FDA’s Mumbai lab.