The life-saving drug albumin will be back in the market within the next two weeks after the Union ministry gave its go-ahead for import of the same.
The drug was in shortage in the market for almost a year. The declaration from the Maharashtra Food and Drugs Department comes close on the heels of authorities writing to the Union Ministry about the shortage of the drug earlier this week.
Human albumin drug is used for treating a variety of conditions, including shock due to blood loss in the body, burns, low protein levels due to surgery or liver failure, and as an additional medicine in bypass surgery. The drug, which is extracted from the plasma of the human blood, is being said to be in short supply due to unavailability of the same. There is no substitute present for the drug. The Maharashtra FDA was waiting for a go-ahead from the Union Ministry for importing the plasma for production of medicines. “Albumin is extracted by two players — Reliance Life Sciences and Intas which is a Gujarat based company. The company has got a go-ahead for its import by the Union Ministry and the medicine will be available in the stores within the next 14 to 15 days which includes production time,” said H.S. Kamble, FDA commissioner.
FDA is also contemplating the possibility of doubling the production for meeting the huge demand for the life-saving medicine.
The FDA has sent the letter to the Union Ministry thrice soon after the drug was found to be in shortage last year. “The two players have began the production,” said Mr Kamble.
The drug being an emergency and essential drug was put under price control as per Drug Price Control Order, (DPCO) 2013, soon after which the drug underwent shortage.
In the absence of the drug, the doctors are using plasma to stabilise the condition of the patients, which according to them carries threat. “The plasma during the manufacture of albulin undergoes processing through a number of ways. This purifies the blood making it free of antigens,” said Dr Suhas V Abhyankar, consultant plastic surgeon, Masina Hospital and Cooper Hospital.
Dr Prakash Jiandani, director of critical care, Wockhardt Hospital, added, “The use of plasma was being made by the doctors 15 to 20 years ago and it is not at all a hundred per cent substitute for patients as threat of infections looms.”
