The Union health ministry’s efforts to destroy 270 lakh doses of expired BCG vaccine kept in the cold storage of the BCG VL Chennai may not succeed, at least in the immediate future, as the unit is unlikely to get permission from the Pollution Control Board (PCB).
For destruction of vaccine, the Lab requires an effluent treatment plant (ETP) and a water treatment plant (WTP). But the unit at present has no ETP and has one old WTP which needs to be validated and get approval from drugs control department. The Pollution Control & Environmental Clearance will be issued only on production of the approvals from the drugs control authorities, according to health ministry sources.
“The water treatment plant and effluent treatment plant are essential for destroying the substance in a scientific manner. BCG is a live attenuated bacteria. Before destruction, it has to be killed by autoclaving using pure water. Autoclaved bacteria have to be tested for percentage of death. Since BCG is a mycobacterium, it is difficult to assure the death of the BCG, hence it has to undergo viability testing. Killed vaccine has to be destroyed after crushing the vials using ETP, for which a separate SoP has to be created. Since BCG is a genetically modified organism, the Pollution Control & Environmental Clearance is essential,” said a vaccine expert.
According to sources, it is for the first time in India that the government is destroying such a huge quantity of vaccine and that too without any fault from the production side. The government could not utilize the vaccine on time. The shelf life of the these doses of vaccine was expired in July 2009, and the total cost comes around Rs.3.51 crore. About 28.5 lakh vials were used for the filling of the vaccine.
However, the company is looking for permission from the PCB for destroying the expired substance in the next three months time. The government of India has given permission to destroy the crores of rupees worth biological preparation kept in the cold storage of the laboratory from the year 2008 onwards, said H G Bramhne, director of the Lab.
According to information received from the health ministry, at the time of suspension of manufacturing licences of the unit on 15.1.2008, it was keeping the same quantity of vaccine in the cold storage. They said all the batches were manufactured between August, 2006 and December, 2007 and the shelf life of BCG vaccine is two years from the date of manufacturing.
The government was procuring the same vaccine from private companies during the period when these 270 lakh doses were lying idle in the shelf. Union health minister Ghulam Nabi Azad had made a comment in this regard in Parliament that the vaccines were purchased at higher rates from the private firms after the closure of the PSU. The BCG vaccine used to cost the ministry Rs.13 per vial in 2007-08 from the BCG Lab. The same was purchased from the private sector at Rs.27.85 per vial in 2009-10 (Rs.14.85 more) and Rs.28.6 in 2010-11 (Rs.15.60 more), according reports from some health ministry officials.
Apart from spending money on purchase of vaccine from private firms, the government also had to incur a combined loss of Rs.45 crore from 2008 to 2010 by way of revenue erosion due to the closure of the three vaccine units. The figure available with health ministry shows that the BCG VL Chennai alone could have saved Rs.22.22 crore during these two years.