Even after failure of the second attempt of Pasteur Institute of India (PII) at Coonoor to produce some quantity of DTP group of vaccines a few months ago, the experimental batches put up for trials on May 23 this year were also proved failure.
According to sources, trials for Batch No. 10A, 10B, 11A, 10D, 10 E have not passed the Maximal Toxin Value (MTV), hence ended in failure. The later experiments of 2 & 3 also failed because of no MTV. One Fermentor culture (200 litre) carried out at the laboratory, yielded no result.
Latest information received from reliable sources indicate that Pasteur Institute has sent two of its technical persons to CRI Kasauli for 15 days manufacturing training to commence a third attempt for the production of DTP vaccines. One of the members had earlier undergone training for 10 days at CRI and he brought new seed copy from there to PIIC for the production of tetanus toxin, but failed in the end. He is also now included in the new team to undergo further training.
The unit had failed in the first two attempts after the Union Government granted permission to manufacture vaccines in February 2010.
The director of the Institute, Dr B Sekhar, in an email to Pharmabiz denied the news about failure. He says that the new tetanus strain received from CRI Kasauli is still undergoing a series of experiments to standardize the preparation of tetanus component as it is a new strain sourced from a different lab.
But in an investigation conducted by Pharmabiz it was learnt that the seed copy received from CRI was not a new strain as pointed out by Dr B Sekhar. According to sources, if it were a new strain it could not be used for the production of tetanus toxin/toxoid unless it was approved by the National Control Authority. Sources said it is the same seed copy of Harward strain which can be allowed to be used in the production of tetanus toxin. The seed copy available at PIIC was also Harward strain and supplied by CRI way back in 1978. Hence the source of seed copy is not a different laboratory, but the one and the same i.e. CRI, Kasauli, they said.
After the revival of the unit, in March 2010, the Institute went into the production of 340 lakh doses of DPT vaccine worth of Rs.6.5 crore. But, the main component of the group, Tetanus Toxoid, it made then had not passed the potency test for which huge number of guinea pigs were used. Hence PIIC became unable to release any dose of vaccine to the country’s use. Its supply commitment was 34 million doses of DTP.
After six months, the PIIC procured some seed copies from CRI Kasauli and made one more attempt expending huge amount. But in the final laboratory animal test, the TT it made during the second attempt, did not pass MTV. That showed a proof of failure.
Later on May 23, the Institute put up some experimental batches for trial, that also did not succeed. Following severe shock, the governing body of the unit decided to send two technical staffs from the TT division to CRI Kasauli to learn the production techniques. It is learnt that the officials namely, Karthik Raja (who had already undergone 10 days training in CRI before the second production) and T Lalitha, Officer in Charge, TT Division, have been deputed as trainees to CRI for 15 days training at the TT Lab in CRI, Kasauli.
Sources in the unit have alleged that production of Tetanus Toxin carried out in the institute as experimental batches was to intentionally delay the formulation of DTP vaccine paving way for private manufactures to monopolize the entire supply of vaccines for the EPI. They are of opinion that the management of the institute is not trying to rectify the production procedures at the tetanus division by utilizing the officers with proven record of production techniques.
They said at present the unit has a stock of only one component of the DTP group, Pertussis vaccine, which is available to the tune of 30 million doses. For DTP formulation, other components, tetanus and diphtheria, are required in the same quantity. Sources said further pooling of pertussis bulks was stopped on instruction of the director. According to them, the director finds faults with machineries and equipment for the recurring failure of the vaccine, but it is just to hide the problems in the production of Tetanus and Diphtheria.
Once up on a time, PIIC had given training to technical staffs of other vaccine manufacturing institutes in the country. Unfortunately now the unit has to send its personnel to another institute to gain the technical know how, employees in the unit lamented.