04 Jun 2012, Rahul Koul, BioSpectrum
Keeping health security of the country in mind and the success of the Universal Immunization Programme (UIP), India has put its focus back on reviving the public sector units (PSUs) for vaccine manufacturing. The government has approved a proposal to establish an Integrated Vaccine Complex (IVC) in Tamil Nadu, a state in southern India. The approval came close on the heels of a government directive to upgrade two other vaccine-manufacturing PSUs, also in Tamil Nadu and revive a third unit in the northern state of Himachal Pradesh. (Read What ails vaccine manufacturing in India)
The government, which faced a lot of criticism for failing to revive the PSUs after it revoked their licenses for vaccine manufacturing in 2008 due to non-compliance with good manufacturing practises (GMP), also came up with a National Vaccine Policy in 2011.
The new complex at Chengalpattu in Kanchipuram district will be established by HLL Life Care, a public sector undertaking of the Ministry of Health and Family Welfare, at an estimated cost of $106 million (Rs 594 crore). The project is likely to be completed by 2014. HLL has also been entrusted with the revival project of the two other PSUs. The government sanctioned $11.6 million (Rs 64.72 crore) and $26.8 million (Rs 149.16 crore) for upgrading Bacillus Calmette-Guérin Vaccine Laboratory (BCGVL) in Guindy and Pasteur Institute of India in Coonoor, respectively.
The IVC, to be the nodal center for research, manufacturing and supply of vaccines under the Universal Immunization Programme (UIP), will supply vaccines at affordable prices. The vaccines to be manufactured in the IVC include the pentavalent combination (DPT plus Hep B plus Hib). This is vital in the wake of the inclusion of pentavalent vaccines in the UIP in December 2011. Started in Tamil Nadu and Kerala, the program has now been expanded to include six more states. It will also manufacture the BCG, measles, hepatitis B, human rabies, Hib and Japanese encephalitis vaccines for the UIP.
The annual capacity of IVC is expected to be around 585 million doses and the vaccines manufactured at the complex are proposed to meet about 75 percent of the total requirement of vaccines under the UIP. The government has already released approximately $5 million (Rs 28 crore) for the project. "We have started on-site preliminary work at the 100 acre area. Project office has started functioning with sufficient staff, including a project officer,'' says Mr M Ayyappan, chairman and managing director, HLL.
A third PSU, Central Research Institute in Kasauli, Himachal Pradesh, too has been revived with the unit producing 134.55 lakh doses of diptheria, pertussis, and tetanus (DPT) vaccine since February 2010 when its suspension of license was revoked. The PII in Coonor will release its first set of anti-rabies vaccines in the market in June 2012. Sources told BioSpectrum that about 39.5 million doses of DPT vaccines will be released in a year by the PII.
The BCGVL in Guindy, which will produce the BCG vaccine, is still to commence manufacturing activities. Hence, the BCG vaccine, which protects against tuberculosis, is being supplied by the Serum Institute of India (SII), Pune, for now. All the three units have also been asked to ensure that their production lines are made fully compliant with the GMP standards within three years.