Although the Union health ministry is trying its level best to revive the vaccine production in its public sector units, the efforts being made by Pasteur Institute of India, Coonoor to produce and supply the DPT group of vaccines for the national immunisation program are not making any headway so far.


A second attempt the unit made recently to manufacture the major component of the group, Tetanus Toxoid after procuring seed copies from CRI Kasauli, has also failed. This shows that Pasteur Institute cannot produce good quality TT, without which it cannot supply DPT (triple antigen) or DT (dual antigen) or TT (mono antigen) to the immunisation programme.


Tetanus Toxoid is the common antigen used to manufacture DPT and DT apart from giving separately to children after three months of their birth and to all the pregnant women from 4th month onwards to avoid tetanus during pregnancy, delivery and childhood tetanus.


Sources from the Institute said, the reason for the recurring failure is because of non-involvement of efficient technical personnel and lack of commitment from the top brass of the unit. They said the Union health ministry has punished the Institute for not satisfying the supply commitment it had made. The institute had earlier made a supply commitment of 34 million doses of DPT, but as the unit failed to deliver the quantity on time, government had to divert the order to private companies.


Going back, as a first attempt after revival, in March 2010, Pasteur Institute went into the production of 340 lakh doses of DPT vaccine worth of Rs.6.5 crore. But, because of the less potent Tetanus Toxoid it made during that period, the unit could not release any vaccine to the country’s use. About the failure, an inquiry was conducted then by the drug authorities.


Keeping this failure in mind, in April this year the management of the institute sent one of its research assistants, Karthikeyaraja, to CRI Kasauli for 10 days training in the manufacturing facility of TT and to procure seed copies from there for Pasteur Institute. Having learnt the techniques of production, he brought 2 seed copies to Coonoor. Pasteur institute revived the seed copies and, out of them, prepared a number of seed copies for the production of TT in its lab. Using the new ones, 18 pots of production medium were prepared and inoculated with the new seed. But in the final laboratory animal test, it did not pass MTV (maximal toxin value). If there is toxin, there should be MTV. Here, the failure shows that there was no production of toxin in the culture.


Sources from the institute have alleged that the series of attempts by the unit have destroyed many a lab testing animals (guinea pigs), one animal costs about Rs.450.


When the news about the repeated failure of tetanus toxin production was out, vaccine experts from the health ministry are raising some serious questions such as, if the same seed copies are working satisfactorily in CRI, why they are not working in Pasteur Institute? Whether the seed of CRI itself is of good quality? Whether the quality of these seeds was ascertained? If so, by whom? CRI is the sole supplier of TT seed in the country for government and all other private companies in India.


The technical expert and the deputy director of PII Coonoor, Dr K R Mani, said that he had earlier brought this matter to the attention of the director of the institute and to the Union health ministry, but no corrective steps were taken. He made some suggestions in order to avoid repeated failure and further delay in the production and supply of the vaccine. According to him, the potential of the efficient and experienced technical hands of the institute should be utilized and non-technical persons be deprived of from the charges of quality control lab. He added that there were no detailed discussion among the senior officers about the production of vaccines. Lack of dedication and responsibility on the part of the leaders of the institute is another reason for the failure, he told Pharmabiz.


As per facts received from the sources, in the production of the component Diphtheria, none of the pools has passed the antigenic purity. The only component available at PII is 30 million doses of Pertussis vaccine. It has passed all the tests.


For one year the institute is spending Rs.3.6 crore for payment of salaries and for chemical and machinery expense it spends Rs.2 crore. The government’s exchequer loses a total of Rs.5 crore per year.


The most important and relevant question is that when will PII Coonoor make the first bulk of good quality DTP. Nobody can answer it.