Even as the Pasteur Institute of India (PII) at Coonoor in Tamil Nadu is yet to receive the cGMP certification from the Central Licensing Approving Authority, the Union health ministry has started sourcing DTP vaccine from the Institute for the Universal Immunisation Programme.
The ministry has sourced 15 lakh doses of DTP vaccine (diphtheria, tetanus, pertussis) from the Institute last week even before completing the work for WHO GMP facilities. It was the first release of DPT vaccine, six batches, from the Institute after the revocation of suspension of production licence in January 2010. The PII’s licence was suspended by the ministry along with CRI, Kasauli and BCG Lab, Chennai on January 15, 2008 for not complying cGMP regulations as per WHO standard.
The Institute is yet to receive cGMP certification, but it has received special permission from the government to produce vaccine in the existing lab, said PII director Dr B Sekhar.
The official launch of the supply of vaccine was held last week at a grand function organised at the institute in which SK Rao, joint secretary, union ministry of health, was present as chief guest, sources from PII told Pharmabiz.
Soon after the revival, PII and CRI Kasauli have ventured into the production of vaccine forgetting the fact that non-compliance of WHO cGMP norms was the cause of the closure. For this, the Institute’s argument is that they got special permission from the government to resume production in the old building with a condition that new facility complying with current GMP standards should be set up within three years.
CRI has got new facility now, but the DTP is produced in the old building. The work for cGMP at Pasteur Institute is progressing at snail’s pace. E A Subramanian, general manager (projects), HLL Lifecare Ltd, which is the nodal agency to construct modern buildings and carry out the upgradation work in CRI, PII and BCG VL, told Pharmabiz that the work at the Pasteur Institute will take another two and a half years time to finish and two years for BCG facility.
The Central Research Institute at Kasauli had started the supply of the combination vaccine (DTP) one year ago by carrying out the production in its old facility which is still lacking the WHO GMP standards. The unit is the first one among the three that has completed the work of upgradation (cGMP) though it is yet to be commissioned.
Meanwhile, several NGOs and social activists who were engaged in the crusade against the closure of these institutes, ask the pertinent question that if the units can produce the vaccine in the old facilities without setting up cGMP standards, why did the government stop the production and closed the plants in 2008?
They also put another query. How much money the government has spent from February 2008 to till date for purchasing vaccines for UIP from private companies? Were the batches of DPT and other vaccines such as TT, DT, BCG, OPV and Measles manufactured and supplied by the public sector units before 2008 for the government’s Expanded Programme of Immunisation, not standard quality?, they ask.
For non-compliance of cGMP regulations, the government cancelled the production licence. When two years passed it gave permission to manufacture the vaccine in the same facilities, and ordered the units to supply the vaccine for the immunisation programme, after another two years.
Dr B Sekhar, the director of PII told this reporter that his company would supply 300 lakh doses of DPT vaccine during 2012-13 for the UIP. To a question he said there is no relation between GMP certification and manufacturing.
When contact, vaccine expert Dr N Elangeswaran said that GMP is required for both manufacturing and marketing of vaccine.