Responding to a public interest petition, a Supreme Court bench comprising Chief Justice K G Balakrishnan and Justice P Sathasivam issued notices to union health minister Anbumani Ramadoss, the central government, the Drug Controller of India, the states of Tamil Nadu and Himachal Pradesh, and the directors of the three institutes.
The closed PSUs – the Central Research Institute, Kasauli, the Pasteur Institute of India, Coonoor, and the BCG Vaccines Lab, Chennai, were manufacturing several vaccines, which were distributed to government hospitals at a fraction of the cost charged by private manufacturers.
Arguing for petitioners S P Shukla, former special secretary in the union government as well as ex-member of the Planning Commission, and NGOs Low Cost Standard Therapeutics, All India Drug Action Network, Society for Scientific Values and Medico Friend Circle, senior advocate Colin Gonsalves cited a recent report of the parliamentary committee on health, which castigated the minister for his action.
The three public sector vaccine units were supplying six essential vaccines as part of the government's universal immunisation programme. These vaccines protect children from diseases like diptheria, pertussis, tetanus, poliomyelitis, measles, and childhood tuberculosis.
The petitioners pointed out that a successful vaccination programme is directly dependent on the availability of affordable vaccines in the country. They pointed to countries like Brazil, Thailand and Indonesia, which have always maintained a strong government presence in drugs and vaccine manufacture.
The vaccines whose production has been halted by the health ministry include the vital oral polio vaccine, the DTP-hepatitis-B combination vaccine and a cost-effective vaccine against Japanese encephalitis; Kausali-based CRI's yellow-fever vaccine and vaccines for tetanus and rabies; and the BCG vaccine produced at Chennai.
Gonsalves argued that the closure of production of vaccines in the three PSUs seriously threaten India's health security and bio-security, especially for children. He repeatedly cited the parliamentary committee, which has expressed serious concern about private manufacturing units taking advantage of this closure to make more money, apart from creating a shortage of these drugs.
"The vaccines produced by the PSUs cost only Rs30 to vaccinate a child with all six essential vaccines for all the required number of doses. Now that they are no longer available, the private sector is already threatening to increase the prices of the vaccines they supply to the government," the PIL said.
"The government's action will not only exacerbate the situation of shortages, but will also result in huge extra expenses due to the government having to buy expensive vaccines from private sector," it said.
The petition said suspension of production in the three most important vaccine units in the PSU sector undermined a century-old effort of building vaccine self-sufficiency. It pointed out that their closure happened at a time when the production in the three PSUs was peaking and the vaccine demand-supply gaps were narrowing; and when there had been no complaint at all on the quality of the vaccines produced.
The petitioners sought a direction to set up a committee of experts to go into the facts and submit a report to the court.