As happened in the case of BCG Vaccine, the Centre may be forced to buy DPT group of vaccine from private companies or import the same from foreign countries to fulfill the requirement of the country’s National Immunization Program next year, it is learnt.

This is on account of the failure of Pasteur Institute of India at Coonoor to manufacture adequate quantity of the vaccine even after seven months of its attempt to produce the same. PPI has written to the Procurement Cell of the Union health ministry that it cannot supply the assigned quantity of DPT in December this year as two of the components, Diphtheria and Tetanus, are contaminated and found unfit for filling. Only one component of DPT namely Pertussis, has passed the test for quality and potency conducted in the laboratory last month.

Central Research Institute (CRI) in Kasauli is now the only supplier from the public sector and it supplies less than the required quantity.

According to sources in the health ministry, this possible shortage caused by the delay in releasing batches from PII, will trigger a rise in the price for DTP vaccine manufactured by private companies whom the government may have to depend for its requirements. Government was getting DTP from PII and CRI Kasauli at a rate of Rs. 1.10 for one dose till the units were ordered to close down in January, 2008. Now, since one of the public sector companies is not able to supply, the private companies may increase their prices citing cost pressure from higher raw material prices, sources said.

As soon as the PII received a go-ahead signal from the union health ministry following the revival decision by the Union health ministry in February this year, the unit has took upon the task of manufacturing a quantity of 32 lakh doses of DPT for supply in 2010. The unit had a plan to go parallel with CRI Kasauli, which proved the quality and started supply of the same group three months ago. In early April this year, by utilizing the existing facilities, PII started the production and within seven months it could manufacture 32 lakh doses of the group but in the quality test held later it was found unfit for filling.

The produced vaccine has to pass the test for quality and potency before it is filled and sent to the Lab of CRI at Kasauli for final test and getting the release order. The fresh product from PII, for which the Institute had to spend over Rs. 3 crore, and an additional Rs. 3.5 crore for purchase of 3.5 lakh vials and same quantity of labels (Vaccine Vial Monitors), cannot be sent for national immunization program. As per the information received from reliable sources, a total of Rs. 6.5 crore have gone waste besides other expenses being incurred by the unit.

But when this reporter spoke to Dr B. Sekar, the director of the Institute, he said the quality test has not completed and it is a continuing process. But he added that there were some quality problems with regard to diphtheria. “Some of the components have contamination problems and we will re-purify them”, he said.

When asked whether the unit can start supply from this month, he said it is not possible, but will try from January next year. To another question if he is sure to release the first batch in January, he said he is not sure.

“We have intimated the procurement cell of the union health ministry about the contamination problems and our inability to supply in December. But we will fulfill our assignment in next year. The schedule for December was 8 million doses that we cannot fulfill, but we will be able to supply 5 million doses each in January, February and March, next year. After it, the quantity can be increased to 6 million”, the director told Pharmabiz.

To a question why this problem was happened, Dr Sekar said there were problems with raw materials and machinery. “I want to supply quality vaccine. The company was closed for more than two years. We are depending upon machinery which is age old. We don’t get services of service engineers on time when they are called up”, he added. He parried a question without saying a clear answer, but said the Institute has no shortage of expert staff.

India needs about 10400000/ (One crore, four lakh) doses of DPT vaccine for a period of 18 months for its National Immunization Program as the estimated number of infants (new births) covered under NIP during this period is 26 lakh. Three doses of DTP are administered on a schedule of three times with first dose on the 45th Day of birth, second dose on the 75th day and the third shot on the 105th day. Besides, a booster dose is given on completion of 18 months, where as BCG is given at the time of birth only.