The Union health ministry has decided to convert the BCG Vaccine Laboratory at Guindy in Chennai into a testing lab for the same vaccine after stopping the ongoing pilot production of the vaccine, it is learnt.
The crucial decision was taken at a meeting in Delhi last month chaired by the Additional Director General of Health Services. After the meeting, the ministry issued the order to all the concerned offices including the manufacturing unit here. The ministry has not,however, made any public announcement to this effect.
Director of the Unit, Dr Usha Soren Singh called a meeting of employees’ union leaders and announced the matter. Sources in the unit said the process of conversion will start very soon even as pilot production of vaccine is going on currently. The Unit has initiated steps for pilot production of Bacillus Calmette-Guerin vaccine in July this year, after a period of thirty months of suspension of its license to manufacture in January 2008.
Although, the Lab had received the order of resumption of vaccine manufacture along with CRI Kasauli and PII Coonoor on February 26 this year, it could resume production only very late. The other two units have not only started production within two months of order came, but also started supplying their products in big way.
Sources said that the batches of vaccine produced in the lab in the last two months have undergone viability testing in the laboratories, but they were found to be negative. The testing proved that the bacteria in the vaccine were not alive which meant that the production was done not in proper condition, and it ensures the fact that the manufacturing unit cannot venture into commercial production or sale in the near future. The testing lab in the unit has tested seven batches and 15 batches were sent to CRI Kasauli for testing, of which the result is awaited.
According to sources, absence of experts might be the reason for the failure. The unit also faces shortage of skilled staff and modern facilities to comply good laboratory practices. The pilot production was commenced at the same facility of the old building for which no renovation was done. The unit has now manufactured 20 batches of BCG vaccines, one batch consists of 15,000 vials.
The former health ministry had also a plan to convert the three public sector vaccine units into testing and training laboratories for which they constituted a committee of experts to work out the conversion project. But, bowing to political pressure, the government had to cancel the project.
BCG Lab is becoming a testing lab when the Tamil Nadu state owned vaccine testing laboratory, King Institute in Chennai, is closing down, complain the BCG employees.