Health dept cites 1998 order to revoke ban on vaccines

THIRUVANANTHAPURAM: The health department on Wednesday lifted a ban on supply of pentavalent vaccine ampoules without the manufacturing date in the state, imposed by the minister following the TOI expose, by quoting a 1998 order from the drugs controller general of India. This newspaper had reported the violation of the Drugs and Cosmetics Act in the supply of vaccines without manufacturing dates to hospitals.
Vaccines from the consignment without the manufacturing date were provided to kids at various primary health centres in the state on the day as part of immunization drive. Interestingly, the pentavalent vaccine was not included in the immunization programme when this no-objection was issued.
Additional director of health services Dr N Sreedhar, who is in charge of the immunisation programme, said the ban was lifted after they found that there was an exemption given to the manufactures of pentavalent vaccine by the drugs controller general of India. "There is an exemption given by the drugs controller general of India (DCGI) to the Serum Institute of India from using the manufacturing date. Hence, we ordered that there was no need for stopping the vaccination programme,'' he said.
It is learnt that the director of health services, who is probing the matter, will submit a report to the health minister in a day or two. The report is also likely to bail out the manufacturers by quoting the DCGI order.
Meanwhile, the copy of the order, quoted by the DHS and additional DHS, in possession of TOI shows that it is just a typed communication in a plain white sheet. Also, it doesn't have the signature of the DCGI. "I am directed to say that this Dte has no objection for labelling of export consignment without mentioning of manufacturing date," says the letter, issued on July 30, 1998. It has been signed by one Aswini Kumar for DCGI, but his designation is conspicuous by its absence. Neither does it carry any official seal of the DCGI.
Asked why the pentavalent vaccines supplied to private hospitals have the manufacturing dates printed on the label unlike those supplied to government hospitals, Sreedhar said it was mandatory that the drugs manufactured in India should go by the Drugs and Cosmetics Act when supplied to hospitals in the country. The pentavalent vaccines are exported to India though it is manufactured in India and hence they have been given some exemptions, he added.