The government has banned Liposomal Amphotericin B, an injection-based drug used to treat potentially life threatening fungal infections, including meningitis. Chemical salt, amphotericin B, features among the National List of Essential Medicines.
Ambisome, Fungizone, Envocin, Lambin and Amphoject are some of the injection-based drugs made from amphotericin B.
“The increasing complaints of potential side-effects on kidney and liver has led us to write letters to state drug regulators. We have asked them to suspend licences for manufacture of Liposomal Amphotericin B. The regulators have informed companies,” GN Singh, Drug Controller General of India (DCGI), told HT.
About seven companies, including Abbott, Sun Pharma, Cipla, Panacea Biotech and Bharat Serums, market or manufacture the same drug under different brand names.
The cost of a single injection is varies from `1,800 to `8,000.
The ban is not the part of previously announced ban on fixed-dose combination (FDC) drugs.
“The decision is taken for patient’s safety and there are many safe alternatives available in the market,” Singh added.
Most of the companies, including Abbott and Panacea Biotech, procure this product under their trade names from outsourced manufacturers.
“Our company does not manufacturer this product and neither carries any licence in this respect. We have sent the above reply to the DCGI,” a spokesperson of Panacea Biotech said.
Cipla, Sun Pharma and Abbott did not respond to HT’s requests for comments.