The Hindu : Ban on anti-rabies vaccine raises eyebrows

Online edition of India's National Newspaper
Saturday, Dec 07, 2002

Southern States

Southern States - Kerala-Thiruvananthapuram

Ban on anti-rabies vaccine raises eyebrows

By M. Dinesh Varma

THIRUVANANTHAPURAM DEC. 6. The ban on the anti-rabies tissue culture vaccine, `Abhayrab', appears headed for a row with the manufacturer, Hyderabad-based Human Biologicals Institute (HBI), alleging that the ban is violative of Central Purchase Committee (CPC) norms and is intended to favour an alternative bidder.

The vaccine was banned by the Central Purchase Committee chairman allegedly on the basis of an isolated case of a patient developing a reaction at a hospital in Kollam on August 14.

According to a representative of the HBI, a wholly owned subsidiary of the National Dairy Development Board, the incident had been reported to the hospital superintendent two months after it occurred, with the adverse reaction confined to Batch No. 90.

Curiously, the company claims that during that period, the particular batch number was not supplied to the CPC, Kerala.

However, an inquiry report by the Drugs Controller had shown that the vaccine had been stored at room temperature in violation of the statutory requirement of storing them in temperatures between two to eight degrees centigrade.

The Controller had directed the withdrawal of Batch No. 90 and sending samples of the drug to the Central Research Institute, Kasouli.

The Controller had also stated that the manufacturer be asked to replace the frozen stock. However, the CPC chairman had ordered a freeze on all stocks of Abhayrab vaccines and placed an interim order with a multinational company, an alternative bidder.

The HBI representative alleged that the CPC chairman's decision to place an interim order with a rival firm was only to favour the latter as in normal procedure the company whose product fails a quality test (where too in this case the fault was with the user-hospital) is asked to replace the stock.

It is also pointed out that the banned tissue culture vaccine priced at Rs. 147 per dose was almost Rs. 77 less than the second bidder and the supply of vaccines for the year 2002- 2003 alone netted savings of Rs. 1.5 crores to the Government.

However, the official version is that the interim order had been placed with the multinational firm because of the need to ensure adequate stocks of anti-rabies vaccine across hospitals in the State until sample reports from Kasouli were obtained.

When contacted, the Health Secretary, K. Ramamoorthi, said the confirmation report on the samples sent to the CRI, Kasouli, was awaited before further action on matter could be taken.

Mr. Ramamoorthi said the entire CPC mechanism was due for a revamp to make it more stringent and transparent.

"The objective of the exercise will be to ensure that only quality players take field at the entry-level'', he said.

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