Following the recall of one batch (P1062/SBP-A) of pentavalent vaccine, Easy Five TT, by the manufacturing company after Tamil Nadu drug control authorities’ seizure of 15063 relabelled vials and freezing of sales of the vaccine, the vaccine expert and former director of the two public sector vaccine manufacturing units, Dr N Elangeswaran has filed a case with the Central Bureau of Investigation (CBI) seeking a probe into the incident.

There was media report that Panacea Biotec, New Delhi, the manufacturer of Easy Five TT, had relabelled the vaccine vials with extended expiry date of March 2014. The company claimed that it got permission to extend the date from Central Drug Standard Control Organisation (CDSCO). The report also reveals that the company pasted the date changed label on the original sticker which showed the date as March 2013. Finding the unethical and illegal act of the manufacturing firm, the Tamil Nadu drug control authorities rose into action and conducted a state wide inspection in the premises of wholesalers and retailers and seized 15063 relabelled vials, said G Selvaraju, director of drugs control, Tamil Nadu.

The petition to CBI by the vaccine expert says that Panacea Biotec had applied for extension of shelf life of the vaccine in 2011 for the product manufactured in the same year, but the permission to extend the date of expiry was given by the Central Research Institute in Kasauli which is not authorized to grant permission as it is not part of CDSCO. Dr Elangeswaran further says that the company had also applied in 2008 for extension of expiry date for which permission was given in 2010 by CDSCO. He says the current seized vials were manufactured in 2011.

It is described in the petition that as per Indian Pharmacopoeia and World Health Organisation (WHO) manual, the shelf life of any vaccine is 24 months. The Easy Five TT manufactured by Panacea Biotec in 2011 carried a label with a shelf life period up to March 2013, which was extended later to 12 more months. The petitioner elaborates that Shantha Biotechnics, Bharat Biotech and Biological Evans in Hyderabad, Serum Institute of India in Pune and Panacea Biotec in New Delhi are the major manufacturers of pentavalent vaccines in India and Sanofi Aventis (France), Crucell (a Dutch Company) and GlaxoSmithKline (GSK) are the major foreign players in the pentavalent vaccine production. The expiry period given for the pentavalent vaccine manufactured by these companies is only 24 months and the claim of Panacea Biotec for 36 months is false and against all norms, the expert says.

Another allegation raised in the petition is that Panacea made a false claim that  CDSCO extended the expiry date after the CDL Kasauli tested the product in January 2012. The petitioner argues that the CDL did not test the vials. According to him the vaccine was recalled and the company was de-listed by WHO in 2011 due to inadequacies in quality assurance process of the company.

The petitioner further says that as per the documents available with him it is clear that the vaccine was not tested by CRI Kasauli. On January 15, 2013, Panacea asked the Laboratory (CRI, Kasuali) to extend the expiry date of the vaccine manufactured during 2011 by a year. An officer in the rank of deputy assistant director in CRI permitted the extension. But, CRI is not authorized to grant permission, the petitioner says.

While speaking to Pharmabiz, Dr Elangeswaran said the government of India introduced the five-in-one pentavalent vaccine in 2009 to the national immunisation programme on the advice of the National Technical Advisory Group on Immunization (NTAGI). The vaccine will replace Diphtheria, Pertussis, Tetanus (DPT) and Hepatitis B injections and additionally provide protection against Haemophilus influenzae type B (Hib) diseases such as meningitis, pneumonia and epiglottitis.

The pentavalent vaccine was first launched as part of UIP in Kerala and Tamil Nadu in December 2011 and was subsequently introduced in Gujarat, Goa, Pondicherry, Haryana, Jammu & Kashmir, Delhi and most recently in Karnataka. It is administered to the infants at the sixth, tenth and 14th week of their birth.

The unearthing of label change allegedly done by the company has forced it to recall all the vials of the batch from the market throughout the country.