The union health ministry has directed the Tamil Nadu Government to submit a detailed report on the alleged deaths of four persons and hospitalization of over 30 people in and around the Trichy district following a Mass Drug Administration programme of Diethylcarbamazine citrate (DEC) tablets to eliminate filariasis.
According to the union health minister Dr. R Anbumani Ramadoss, his ministry has sought a detailed report from the Tamil Nadu Government, following the incident. DEC is known to be a safe drug and is unlikely to kill people. Even the union minister himself and the top officials of the health ministry had consumed the tablets during the inauguration of the national MDA campaign at Thane in Maharashtra on June 5. The deaths could be due to some other clinical reasons, and the union health ministry is awaiting a detailed report from the Tamil Nadu Government to ascertain the facts and to identify the cause of deaths, said the minister.
Meanwhile, there are allegations that the deaths were caused by contamination of drugs manufactured by one particular company, which supplied drugs for the programme. Quoting an anonymous top-level sate health official, a news agency report from Trichy said the lab report on the retrieved tablets from Trichy has indicted the company of manufacturing the drug with a few 'excessive' ingredients, fortified that that they are bound to have side effects'.
Though the tablets lack any pharmacopial defects, they were found to have been manufactured under 'unhygienic conditions and tests proved presence of contaminated ingredients in the tablets. However, the contamination could have caused only dizziness, diarrhoea, nausea and vomiting and deaths were unlikely to occur by those tablets, said the report. Samples from 33 batches of the retrieved drugs supplied in the Trichy region were tested, said the sources.
However, when Pharmabiz contacted the Tamil Nadu Drug Controller, he said the DEC tablet samples retrieved from Trichy tested at the state drug control laboratory in Chennai were found to be of good quality. "Initial reports suggest the drugs are of good quality. I am yet to study the detailed report," said the DC.
It is to be noted that there were concern over the quality of the DEC tablets, which were supplied for the programme in Kerala planned during 5th of June, this year. The tablets were packed in ordinary polythene covers and many packets had only powdered tablets, which were not suitable for supply in the programme. Following the controversy, the Kerala Government postponed the programme citing reasons like non-availability of drugs for conducting the MDA programme on the same day in all the endemic districts of the state.
Sources point out the allegations on quality could point fingers at the union health ministry itself, as the Centre directly implements the programme. The Centre procures the DEC tablets and the firms that supply the drug have to be in accordance to the prescribed manufacturing facilities as per the guidelines of the WHO, which implements the programme in more than 62 countries. Sources associated with the programme allege many of the companies supplying drugs for the programme do not conform to the stipulations prescribed by WHO.