Kala-azar drug found sub-standard

patna: five batches of sodium antimony gluconate (sag), a first line drug for the treatment of kala-azar, supplied by the centre to bihar, turned out to be sub-standard during the tests conducted at the central indian pharmaceutical laboratory (cipl), ghaziabad. six kala-azar patients had died in the state -- five in sitamarhi district and one in madhubani district -- following the administration of the drug a couple of months back.the laboratory said in its reports that the samples of five batches of the drug were not of standard quality as defined in the drugs and cosmetics act, 1940 and the related rules. the five batches did not conform to the requirements of indian pharmacopia (ip). besides, they also caused lowering of blood sugar though it was not mentioned on the label. the reports further said that the samples contained phenol as preservative. however, as per the amendment to ip 96, notified by the drug controller general (india), in a multidose pack a preservative other than phenol should be used, the note said. the sixth batch of the drug was found to be of standard quality, the report said, though it was also found to lower sugar level and contained phenol as a preservative. the state government received the reports on monday. the copies of the reports have also been made available to the chief malaria officer (cmo) by the state. the state drug controller, sangeet kumar sinha, while confirming that the five batches of the sag were found to be sub-standard, said that the drug was manufactured by toshika international limited, chandigarh, and was supplied to the state by a noida-based central government undertaking, hospital services consultancy corporation (india) limited. he said that the state government had banned the use of the drug following the death of six patients. the state government had sent the five batches of sag for chemical test on march 31, much before the death of kala-azar patients following its administration. top sources in the health department said that the department had also sent sample of one batch of the drug to bit, mesra, ranchi, for chemical test, where too, it was found to be sub-standard. the chemical test reports of all the six batches of the sag have been sent to the drug controller general (india) by the central laboratory. it may be recalled here that the union health minister, dr c p thakur, had earlier announced that he would order a cbi probe into the alleged supply of sub-standard sag to bihar if the allegation was proved correct following the chemical test. soon after the deaths of six kala-azar patients in the state, bihar health minister shakuni chaudhary had charged the centre with supplying spurious kala-azar drug to the state. the centre, too, had collected samples of the said drug following the deaths and sent them for chemical test. however, the reports are still awaited. (sachchidatoi@indiatimes.com)