The Supreme Court Monday sought the central government’s response on the plea seeking a stop to manufacture, use and sale of the 5-in-1 Pentavalent vaccine – that inoculates for hepatitis-B, and haemophilus influenzae Type b besides diphtheria, pertussis, and tetanus.
Besides the central government, the notice has also been issued to the Drug Controller of India, the Christian Medical College at Vellore and others.
A bench of Chief Justice P. Sathasivam and Justice Ranjana Prakash Desai issued notice as senior counsel Colin Gonsalves told the court that the pentavalent vaccine was being pushed as a replacement for the DPT (diphtheria, pertussis, tetanus) vaccine given to infants.
PIL petitioner Yogesh Jain in his petition said that 5-in-1 pentavalent vaccine that adds hepatitis B and Hib to the traditional DPT vaccine was introduced in India after a limited year-long trial in Kerala and Tamil Nadu.
“Soon after initiation in the state Universal Immunisation Programmes (UIPs), infant deaths were reported. Till date at least 21 deaths have been reported in India. Experts estimate that many more deaths have gone unreported,” contended Jain.
“In reality, the disease burdens of Hib and Hep B in India are so low that the deaths from the vaccine outnumber lives saved from diseases,” he claimed.
The PIL said that the government and the Drug Controller have failed to adhere to their constitutional obligations to protect the rights of Indian children and families enshrined under Article 21 of the constitution by failing to monitor, report, and take action in the face of deaths from the pentavalent vaccine.
Gonsalves said that the pentavalent vaccine was not in use in America, Canada, Europe, Japan, and its use was put to halt in Pakistan, Vietnam, Bhutan, and Sri Lanka immediately after reports of serious adverse events and deaths.
Seeking the withdrawal of the vaccine from the UIPs, the PIL has sought compensation for the families of the children who have suffered adverse side-effects or died.