Samples of a batch of Intravenous fluid (I.V.) cleared by the Kerala State Drugs Control Department after tests at its laboratory are alleged to have been contaminated with fungus. This was discovered in tests conducted at the Microbiology laboratory of the Thrissur Government Medical College.
According to various sources, sample tests of Ringer Lactate I.V. fluid out of the stocks available at the hospital revealed presence of the fungus. The infected IV fluids belong to the batch 13 P 9558 manufactured by Kokkad Pharmaceuticals, Kottayam, and was sourced by the Central Purchase Committee (C.P.C.) of the Kerala Government as per the tender norms.
Last year, the medical college authorities had sent samples of the same batch for further tests to the state drug control office following complaints of dizziness and shivering to the patients administered with the IV fluid during the months of May and July 2003.
Following the quality tests at drug control laboratory, Thiruvananthapuram, the Assistant Drugs Controller office had informed the medical college superintendent to further use the same IV fluids as the sample tests were satisfactory. More than 1000 dripper bottles of the same batch have been stocked with the various Government hospitals, including 36 in Thrissur medical college. The hospital authorities are now forced to use the same drug as the authorities had given the clearance, alleged sources.
When contacted, T.P.Gopinathan, Kerala State Drug Controller told Pharmabiz that he was yet to receive detailed information on the matter and alleged the hospital authorities were blowing the matter out of proportion. "We clearly indicate in the sample test report to discontinue usage of the drugs if found with suspended particles or suspicion of infection. We take about 20 random samples and test it, and practically it is impossible to test the whole batch. That does not mean our tests are qualitatively inferior or we consciously gave green signal for a product with fungus in it" said the DC.
He also noted it was easy for I.V. fluids to be infected through improper handling or conscious efforts like injecting external substances. "I am waiting for detailed information, and shall do the needful" said the DC who also mentioned that 'some of the doctors at Thrissur Medical College were keen to inflate the issue".