Even as the paucity of the life saving drug human albumin serum has been persisting for the past several months in retail and hospital pharmacies, Maharashtra FDA has confiscated drugs worth Rs.1.5 lakh from a Mumbai based stockist Nexus Lifecare Pvt Ltd and filed a case against the company in the court in violation of Drug Price Control Order (DPCO-2013).
Maharashtra FDA team from its Mumbai-based headquarters found that the Mumbai based stockist Nexus Lifecare Pvt Ltd was selling Human Albumin at overpriced rate. Stockists in the country have stopped importing the drug after it came under the new DPCO-2013. Meanwhile, Reliance Life Sciences is, however, awaiting government approval on imports of plasma required for its production on a large scale.
While hospitals and distributors have run out of supplies in India, retail pharmacies also have started feeling the heat recently. Shortages have been reported in pharmacies and hospitals in cities like Mumbai, Pune, Delhi, Kolkata, Chennai, Gujarat etc. Pharmaceutical companies Reliance, Intas, Bharat Serums and Baxter were major manufacturers and suppliers of albumin in Indian markets. After slashing of prices, they have stopped supply to domestic markets.
"Shortage of albumin can be attributed to the fact that the drug has been brought under the new drug price control -2013. In such a scenario, some manufacturers might also resort to exporting the drug at higher prices for the sake of earning good profit," says Hakim Kapasi, president, North West Chemist Association in Mumbai.
A chemist further informs, "We have got 2 to 3 enquiries on a weekly basis over the past several weeks for albumin from desperate families of patients as it is no more available in hospitals. It has really been a tough time procuring stocks of albumin both for the pharmacies, hospitals and patients."
According to a Mumbai based chemist, "Human albumin low sodium of 20 per cent strength in 100 ml used to cost around Rs.4,904 but was sold at a higher price of Rs.5,980 due to the shortage following NPPA price cut. The emergency drug which is generally being used as a life saving drug in cases of severe blood loss or in trauma cases was earlier being imported by few companies in India."
It has been learnt that scarcity of certain essential medicines, namely, anti-snake venom, rabies vaccine, rabies immunoglobulin, albumin injection and anti-malarial combination of sulfadoxine + pyrimethamine tablets has been reported to the NPPA.
As per a NPPA notification of September 9, 2014, absence of regular reporting under DPCO, 2013 by the manufacturers, it appears that the concerned manufacturers are not maintaining normal supplies of these medicines in domestic market and/or institutions. Hence, the availability of such vital and essential drugs has been affected many parts of the country. Now, therefore, in exercise of the powers delegated under para 21(1) and para 29 of the Drugs (Prices Control) Order, 2013 vide S.O. No. 1394(E) dated 30th May, 2013 issued by the Government of India in the Ministry of Chemicals and Fertilizers, in exercise of powers conferred by section 3 and 5 of the Essential Commodities Act, 1955, the National Pharmaceutical Pricing Authority after being satisfied that it is necessary in the public interest so to do, hereby direct that all the concerned manufacturers/importers shall comply with the requirements contained in para 21(1) and provide the month-wise production and sale figures for the last 12 months under para 29 of the said Order immediately to the NPPA.
After any supra major surgery such as a kidney or a liver transplant the body does not produce adequate albumin. Transfusion of human albumin is, therefore, required in process of healing or to reduce water retention and swelling conditions caused in the body due to an infection or a disease.
Human albumin serum is a protein in human plasma of the blood which is produced in liver. It maintains levels of calcium in the body and transports nutrients or drugs effectively in the blood stream. The body can suffer a shortage of albumin if a patient is affected by liver disease, kidney failure, burns, malnourishment. In kidney transplants, when the blood group of the donor and the recipient does not match, plasma content in the recipient's blood has to be drained and albumin has to be transfused so that the donated kidney may not be rejected.