IN an appalling triumph of pelf and politics over probity, the Mumbai high court may have sentenced 43 million children to the risk of polio. On August 19, the court ordered the Union government to purchase 43 million potentially unfit oral polio vaccines from Haffkine Bio-pharmaceutical Corporation Ltd, a Maharashtra government undertaking, for this year's Pulse Polio Immunisation Programme. It also cautioned the government against encouraging private sector in areas involving public health care. While there has been no response from the ministry yet, an official said it might take the matter to the Supreme Court.
There are three reasons why Haffkine's vaccines may fail against the polio virus. First, the central government norm is not to purchase any vaccine that has completed more than one-sixth of its life. The Haffkine lot is already more than a year old—four months over the required norm. Also, by the time they're administered in December and January, the vaccines may have turned effete since they're essentially weakened 'live' viruses that may not hold out for very long.
Second, there is no way of checking their fitness. Unlike vaccines produced by other manufacturers, Haffkine's are not equipped with a Vaccine Vial Monitor (VVM) which changes colour to indicate loss of potency. Since the polio vaccine is extremely sensitive, it has to be stored at -20° celsius for it to remain potent. The monitor was made mandatory only this year following reports of some vaccines turning ineffective due to variation in temperature. In Meerut alone, a batch of more than 65,000 vaccines was withdrawn last year because a supposedly immunised child succumbed to the polio virus. A WHO study says that 25 per cent of polio vaccines administered in Mumbai in 1996-97 had lost their efficacy.
Third, the bulk concentrate Haffkine used to manufacture the vaccines is not from a WHO-certified supplier as is required by the Union government. Indian companies import the concentrate largely from the US and Belgium, both approved by WHO; bottle them here. But Haffkine imported its raw material from Yugoslavia which is not approved by WHO. India needs about 5,200 lakh doses of polio vaccines annually. While part of it is sponsored by international developmental agencies, the rest, worth about Rs 50-60 crore, is bought off the market. The requirement this year is about 260 million doses. The court has ordered the central government to lift Haffkine's 43 million first; distribute the remaining among other bidders in proportion to their capacity.
But why did Haffkine produce 43 million vaccines even before the tender was issued? Because they were confident they'd get the bulk of the order. However, the company lost the bid and was unable to match the lowest bidder after two successive negotiations. It had quoted the lowest price in the first round of bidding but lost out in the second round of negotiation which the government undertakes to bring down the rate even further. Each bidder is then given an order in proportion to its capacity. This is done to ensure that the government doesn't become dependent on one manufacturer.
As it happened, of the four bidders, two, Radicura and Bibcol, agreed to supply the vaccines at a rate Haffkine couldn't outbid. Haffkine, however, was adamant about the Union government lifting its 43 million vaccines first. When this didn't happen, the company petitioned the high court asking it to direct the Centre to buy its old stock saying they'd match the lowest bid if the quantity ordered was guaranteed. Haffkine in its petition also asked for 50 per cent of all orders for supply of polio vaccines. The state government supported Haffkine's petition offering to ensure that the vaccines would be distributed in Maharashtra only.
In its reply, the ministry of health and family welfare says Haffkine can't have special privilege to 50 per cent of all orders. It says that "the rate contract doesn't imply any commitment to procure any given quantity. Their offer of a 2 per cent discount is dependent on a minimum guaranteed off-take. Such an offer can't be accepted as it's unfair to other bidders."
Meanwhile, the state government's offer to use the entire old stock in Maharashtra sounds ludicrous. The state's requirement can't possibly be 40 million doses. Haffkine knows it has been overenterprising and must somehow sell its stock to avoid a loss of about Rs 15 crore. In fact, the court ruled in Haffkine's favour saying that if the stock is not bought it would "amount to a national loss". It does not matter, of course, if in the process some children out of thousands are stricken with polio.