The Tamil Nadu Drugs Control Department has rejected the application for renewal of licence submitted by Pasteur Institute of India, Coonoor (PIIC) for the manufacture and supply of DPT vaccines. The Institute had applied for new licence on April 26 this year.

Last week the state director of drugs control department, M Bhaskaran, wrote to PIIC asking them to intimate him a convenient date for inspection along with CDSCO staff. According to sources, the HoD of the Quality Assurance Department has replied to the director of drugs control that it would not be possible to completely rectify all the deficiencies in the lab, especially the structure and manpower are concerned. It is learnt that following this statement of the HoD, the state drug control authorities have intimated them on 28th of December that until the rectification of whole deficiencies are completed, the renewal of application cannot be considered and hence it is rejected.

When contacted the director of drugs control, M Bhaskaran, said the application was about WHO GMP licence, but parried all other queries.

When contacted CDSCO offices in New Delhi and in Chennai, they said joint inspection would be held in the BCG Vaccine Lab in Chennai on 29th of this month.

According to sources, PIIC and BCG VL were manufacturing vaccines without renewal of licences after their suspension of production licences in February this year. But another public sector vaccine manufacturing unit, CRI Kasauli got new licence soon after its revival and started production and supply thereafter. All these three units were ordered by central health ministry to go ahead with production with the existing facilities. But they need to have manufacturing and supply licences from the state authorities which these units failed to procure so far.

Production in PIIC is still going on, but it will be stopped soon following the rejection of licence application by state drug authorities, sources said.

Meanwhile, the 32 lakh doses of DTP group of vaccines manufactured, has failed the quality test conducted there which may force the government to buy DPT group from private companies for National immunization program. Same is the case with BCG vaccine which the government is procuring from private companies for administering the new born babies.

As per the information received from reliable sources, PIIC spent Rs. 6.5 crore for the production of DTP vaccine which have gone waste besides other expenses being incurred by the unit.