The health department of Tamil Nadu government is yet to take a decision regarding the remaining stock of measles vaccine held in the cold storage from April 23 onwards after the deaths of four children soon after administering the vaccine.

The Hyderabad based Human Biologicals Institute had supplied the vaccine for the immunization programme in the state. The state government soon after the deaths suspended the use of the vaccine in the state.

Samples of the vaccine inoculated on children were taken to the Central Drug Laboratory at Kasauli for testing. The test report, which the CDL sent to the Drugs Controller General of India, says that the vaccine is not contaminated and safe as well as effective.

The director of the State Health Department Dr Padmanaban told Pharmabiz that the department would take further steps in this regard only after getting orders from the Union health ministry. "We are waiting for the clearance of the health ministry. The rest of the vaccines are in the storage. Whether to use or not to use, will be decided after health ministry's instructions", the director said.

But the inspection team of the health ministry who visited the vaccine-manufacturing unit in Hyderabad soon after the incident found that the public sector unit was not complying with the GMP norms. Now the authorities in the health ministry are of the opinion that human error at the local level could possibly have resulted in the death of the children.

The report of the Central Drug Laboratory will be forwarded to the Department of Family Welfare, which will take further action, including issuing directives to the state government, it is learnt.

To a query, Dr Senthamizhan, the in charge of the immunization programme in Tamil Nadu, said the village staff nurses who had administered the vaccines, were suspended and action will be taken if human errors are found at the local level.

According to Dinar Kumar, general manager of HBI, Hyderabad, the institute will look into the matter of GMP compliance only on receiving the report". We are yet to see the findings of the experts team. We will act on health ministry's order", he said.

However, in a statement earlier the Human Biological Institute, Hyderabad stated that it had manufactured an approximate quantity of 2,50,000 doses of measles vaccine in February this year, out of which 1,45,000 doses were supplied to Tamil Nadu for immunization programme and 55,000 doses were supplied to Uttar Pradesh as per instructions of the ministry of health. The expiry date of the vaccine was January 2010.

Out of the 1,45,000 doses of the batch supplied to Tamil Nadu, 20,000 doses were used without any adverse effects from April 4 to 23. The vaccination camps were reportedly started from April 23 in seven villages and deaths of three children were reported in two villages. A total of 276 children were inoculated under the same PHC across seven villages on that day. However, no serious adverse reaction was detected in five other villages. The same vaccine was used even in the previous week without any incident, the statement said.

The institute claimed that the measles vaccine manufactured by it was brought to the market after meeting stiff regulatory requirements, which include multi-centre clinical trials to establish safety and efficacy of the vaccine.