Indian authorities probing vaccine deaths in southern India last month have given a clean chit to the manufacturers of the vaccine, but a fresh controversy has broken out over the syringes used.
It was on April 23, four children, all below 10 months, died minutes after they were given measles shots by nurses in Tiruvallur district in Tamil Nadu. Subsequently the use of the vaccine manufactured by the Human Biologicals Institute was suspended.
On Thursday the measles vaccine was declared "safe and effective" by a panel of experts, but the HBI production unit in Hyderabad was found to be flouting good manufacturing practice (GMP) norms put in place by the World Health Organisation.
A member of the panel told Times of India, "We inspected the vaccine production area, its quality control measures and the raw materials being used. We have warned HBI of serious GMP violations, which put at risk the quality. Their records showed high rate of rejection. While their licensure load was validated for 30,000 vials, they were using it for 60,000 vials, jeopardising proficiency. HBI, which is a pre-qualified WHO unit, has been told to improve their standards."
But that was not the end of the story. Tamil Nadu wrote to Union minister Anbumani Ramadoss complaining that the auto disabled (AD) syringes provided by the federal Health Ministry for immunisation programmes were "substandard'' and that their needles were 'rusted.'
Reacting to the allegation, Dr. Anbumani Ramadoss, said that he had directed the Drug Controller General of India (DCGI) Dr Surinder Singh to immediately despatch teams across the country, including Tamil Nadu, and pick up the AD syringe samples to check whether the needles had actually rusted or not.
"Until now, we have not received a single complaint about these syringes. I have asked DCGI to give me an official report within a week after inspecting the AD syringes picked up from all the states,'' Dr. Ramadoss said.
He also said that India was moving towards exclusively using AD syringes, both in the immunization programme and in all government hospitals.
Auto Disabled (AD) Syringes cannot be used more than once. After one shot, the syringes get locked and do not draw in any more medicine.
Tamil Nadu Health Minister M.K. Panneerselvan, however, insisted that if the AD syringes were used, `the immunisation programme will collapse again and there may be adverse reactions.'' Therefore the use of these syringes had been completely stopped in the State. "I request you to take immediate action to supply good quality syringes. As AD Syringes are supplied to all the states I request that suitable instruction may be communicated to them to check the quality of the syringes," he said in his letter.
DCGI Surinder Singh, now inspecting the syringes in Tamil Nadu, said, "Chances of AD syringe needles being rusty is remote. The needles are made of pure stainless steel and can be used only once. We are presently studying the distribution patterns of this batch before samples are picked up. Our probe will see whether the needles were made of substandard material, which caused it to rust, if at all."
Meanwhile, the Directorate of Public Health in Chennai has sent notices to all the health units in the state directing them not to use the auto disabled syringes. "We have replaced the AD needles with disposable syringes to avoid any further problem," officials said.
India uses 150 million AD syringes in its immunisation programme annually, 80% of which is supplied by Becton Dickinson India. The batch under question in TN were syringes procured from Spain.
Ram Sharma, managing director of BD India, said there was no question of the syringes being defective.
"The AD syringe facility in Fraga, Spain, has been WHO qualified to supply to all immunisation programmes."