India, despite having major public sector units capable of producing vaccines, still sources the bulk of its vaccines from the private sector.
In January 2008, three PSUs (Central Research Institute, Kasauli, and Pasteur Institute of India, Coonoor, and BCG Vaccine Lab, Chennai) were shut down citing non-compliance with the World Health Organisation’s good manufacturing practices (GMP). Since then, the contribution of these institutions that originally met a substantial portion of the country’s requirement under the Universal Immunisation Programme (UIP) has dwindled and, in one case, stopped completely.
This, despite the recommendations of a Parliamentary Standing Committee on Health recommending strongly that manufacturing be kick-started at the three units after ensuring that GMP are adhered to. They also recommended pumping funds into the three institutions in order to make them viable again.
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However, in 2012-2013, out of a total of 19,853 lakh doses procured in the country, only 1,095 doses came from two public sector units (CRI and PII), where production has revived. There is no production at the BCG Vaccine Lab.
Responding to an RTI application by K.V. Babu, a doctor based in Kerala, the Vaccine Procurement Cell of the Ministry of Health and Family Welfare has shown that the vaccine supply from PII and CRI has come down drastically in terms of share in the Universal Immunisation Programme. At one point, the BCG lab supplied the country’s entire stock of BCG vaccine — 894 doses in 2006-2007. In 2013, 502 lakh doses BCG were procured, not one from BCG.
BCG, DPT and TT are the vaccines primarily provided by the Public sector units. Of the 2,051 lakh doses of DPT, only 745 lakh doses were supplied by the government institutions, only 36 per cent of the whole. In 2006-2007, the government institutes’ contribution was 92 per cent of the total vaccine procurement. Of the total of 1,490 lakh doses of TT, only 350 lakh doses, or 23 per cent, were supplied by the government institutes. In 2006-2007, it was 80 per cent.
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The costs have gone up substantially in 2012-2013, with Rs. 1,045 crore being spent by the government on vaccines. Even accounting for inflation and rise in cost per vial of vaccine, it does not explain that only a sum of Rs. 7.46 crore has gone to the two functioning institutes: CRI — Rs. 4.43 crore and PII — 3.03 crore.
The plan was to set up an Integrated Central Vaccine Park in Chengalpattu, and it was projected to be up and functioning by 2012. However, according to sources at HLL Lifecare tasked with implementing the project, government clearances are being sought for civil works. Construction is likely to start from May 1 this year, and the plant will be fully-functional four years from then.
“The Parliamentary Standing Committee made a clear statement about reviving function in the three institutes ordered to be closed. It is a criminal waste to overlook such resources in the public sector. Efforts have to be made to get all the institutes to fully-functional units, manufacturing to capacity. And from there, it is a question of government procuring the vaccines made by these units,” says Dr. Babu.
A campaigner for the opening of the PSUs, Chennai-based paediatrician Rex Sargunam says revival of function at CRI and PII is a sign of hope for BCG as well. The BCG Lab, after adequate clearances have been sought, must start production of the vaccine soon, he adds.