The uncertainty about the future of BCG Vaccine Lab in Chennai is likely to subside as HLL Lifecare Ltd, the nodal agency to overhaul and revamp the three vaccine manufacturing units in the public sector will submit a renovation project report to the union health ministry this week.
The report will include construction of a new cGMP building adjacent to the existing lab for biological processes, said E A Subrahmanian, vice-president (projects), HLL Lifecare Ltd.
Upon construction of the new building and establishment of modern facilities, the age old vaccine manufacturing unit can retain its honour and continue the production of BCG Vaccine which was facing uncertainty for the last two years.
Subrahmanian said that the existing building that housing the laboratory is unfit for establishing GMP facilities. Health ministry officials have also accepted this fact. The same opinion has come out from the WHO officials after a single look at the building. Scientists from WHO visited the institute in the first week of April, he said.
“The existing building is very old, it cannot be converted into GMP facility. A new one has to be constructed entirely for the purposes of biological purposes. However, the old building and other structures can be used for other accessories. We have visited the place twice with officials from WHO and Union Health Ministry and made a draft proposal based on our observation and future plan. The report will be submitted to the government within two days”, he told Pharmabiz.
The HLL project officer said the construction of GMP facilities in CRI Kasauli is almost finished and it will be commissioned very soon. Establishment of water connection and power connection to the new building is yet to start. HLL has also engaged in the setting up of modern facilities in PII Coonoor.
Even after one year of the government’s decision to restart production in the unit and allotted a huge sum for renovation and other expenses, no work or modification has been done in the unit. In February 2010, the health ministry revoked the suspension of license. But the BCG VL’s attempt to go with production has failed due to technical problems and lack of expertise. Later on government has ordered the director of the Institute to withhold modification work, if anything was undertaken. Further, the ministry has found that the seeds strain in the unit became niacin positive and it cannot be used for making vaccine. This has again led the unit to close down its laboratory and become unable to go with production processes.
Taking note of the seriousness of the situation, the former director of the BCG Vaccine Lab, Dr N Elangeswaran, has written to the union health ministry that the BCG seeds that changed into niacin positive can be reversed to its original bio-chemical characteristics through reattenuation process which may help further production. But the ministry has not responded positively to his suggestion, it is learnt.
Meanwhile, Dr Rex Sargunam, the president of Tamil Nadu Health Development Association has said the government should utilize the expertise and experience of Dr Elangeswaran for the manufacture of BCG Vaccine as the public sector unit is the only reliable source of vaccine for the lakhs of new born babies in the country.
Dr Rex said his organization will approach the union government with a request to consider the suggestions of the government recognized vaccine expert, Dr Elangeswaran.