The recall of one batch of (P1062/SBP-A) of pentavalent vaccine, Easy Five TT, from the market by Panacea Biotec has triggered a debate among vaccine experts and immunisation officials as to whether the National Regulatory Authority (NRA) is acting properly and independently.
Panacea Biotec ventured to recall the product following the Tamil Nadu drug authority’s recent seizure of 15063 relabelled vials and freezing of sales of the vaccine. In the wake of the recall, a vaccine expert from Chennai has approached the central investigating agency seeking a probe into the incident.
This is not the first time, a vaccine introduced in the list of immunisation programme is recalled either by the company or by WHO for myriad reasons, experts opine. Quoting examples they question the integrity of the regulatory authority in initiating actions. Major private vaccine manufacturing companies - Serum Institute in Pune, Panacea Biotec in New Delhi, Bharath Biotech, Shanta Biotech and Biological Evans in Hyderabad started manufacture and supply of combination vaccines in 2008.
In 2008, deaths of infants occurred in Thiruvallur district of Tamil Nadu allegedly after administering measles vaccine supplied by Indian Immunological Ltd, Hyderabad. Theirs was a WHO approved facility. According to information received from sources Indian immunological Ltd was supplying measles vaccines for the first time in the history of immunisation programme in India and that too was on a trial order, not on the full order. Following the incident ninety lakh doses of measles vaccines procured from Indian Immunological Ltd were withdrawn by the Health Ministry.
There were reports of deaths of several children occurred in a neighbouring country in 2009 after administration of pentavalent vaccine supplied by an international company and manufactured by an Indian firm. Following the tragedy, WHO recalled the whole batches of the vaccine. The company got the order in 2008 and the deaths occurred in 2009 after immunisation programme.
In 2010, WHO removed the pentavalent vaccine, Shan 5 (DTP, hepatitis B, Hib) manufactured by Shanta Biotech, Hyderabad from the list of pre-qualified vaccines. The action was taken following incidents of white sediment sticking to Shan 5 vaccine vials.
In 2009, Panacea Biotec, New Delhi received the order from WHO to supply 75 million doses of pentavalent vaccine (Easy Five TT) for the period, 2009, 2010 and 2011. But the same WHO disqualified three combination vaccines of the same company, (Easy Five, Ecovac 4 and Enivac HB) on 17.8.2011 following a routine audit conducted in June 2011 at Panacea’s manufacturing sites and identified “serious inadequacies in quality assurance process.” Following the report, WHO recalled the five-in-one combination vaccine.
In 2012, the WHO suspended the supply of its Hepatitis B vaccine, Revac B+, manufactured by Bharat Biotech, Hyderabad because of its failure to meet WHO's manufacturing and quality standards. This gross violation of GMP compliance forced WHO to recall the vaccine from the universal immunisation programme.
All these anomalies in the private companies were found out during the period from 2008 to 2012. But, none of the companies was given a closure notice or served a licence suspension order by then the DCGI. Whereas, the three government vaccine manufacturing units (BCG VL, PII & CRI) were made static by closing down its shutters citing non-compliance of WHO GMP norms by the DCGI.
What is surprising is that there was no incident of death or adverse effect reported from the administration of vaccines supplied by the government institutes during these periods. No action against the erring private companies which fail to adhere to regulations, but killing the country’s own responsible institutions.