Concerned over an imminent shortage of BCG and DPT group of vaccines and anticipating a further possible closure of the Tamil Nadu based two government vaccine units, the Tamil Nadu Health Development Association (TNHDA), an NGO, is planning to approach the Prime Minister and the Union health minister shortly.

The Association will also mobilize support of other NGOs and like-minded people to apprise the Government about the present status of the vaccine manufacturing units in the state and request for immediate intervention of the prime minister.

The NGO is of the view  that as the operations of  PII Coonoor and BCG Vaccine Lab Chennai, are not viable even after ten months of revocation of licence suspension, the Centre may change its policy for a further shut down and go for a contract with private companies to buy vaccine for the NIP. While giving permission for restarting operations of these two units in February 2010 along with CRI Kasauli, the Union health ministry had strictly instructed the units to ensure that the production line was made fully compliant with GMP norms within three years from the date of issue of the order.

 But, so far these two units have not done anything to comply with WHO-GMP norms besides failing to supply even a single dose of vaccine to the country’s immunization program. CRI in Kasauli, however, has started construction of modern facilities along with its production of vaccines. Within six months of its revival, CRI has started supply also, said its former director-in charge, Dr K V Mani. He said before he was relieved of the post, he invited the central and state regulatory officials to conduct the site inspection and renewed its licence so as to carry on with the vaccine production.

Last month the Tamil Nadu Drugs Control Department rejected the application submitted by Pasteur Institute for renewal of its WHO-GMP licence saying that it cannot be considered as the Institute could not rectify the deficiencies, especially those relating to structure and manpower found during the inspection in 2007. About 32 lakh doses of DPT vaccine it produced after its revival have also not passed the quality test and that made the unit to incur a big loss. It had promised the health ministry that it could supply 50 lakh doses in last December for the immunization program but that did not happen.

Like in the case of PIIC, the BCG VL in Chennai too could not comply with GMP norms. Even though a joint inspection was not done there so far, the central drug regulatory agency conducted its inspection last week. Soon after the revival order was issued by the ministry, BCG also got into the process of resuming production, but could not contribute a single dose for the country’s use.

Dr C S Rex Sargunam, former Director and Superintend of ICH & HC Chennai, and the president of TNHDA maintained that on behalf of millions of children and poor people in the country his association has decided to take the issue with the PMO. He will mobilize the support of other NGOs in the state for this end.