Updated on 16 April 2012
In August 2011, Panacea Biotec, which was among the first companies to launch a pentavalent vaccine, had their WHO pre-qualification approval withdrawn after a routine audit due to inadequate quality assurance processes. The statement by the WHO states that EasyFive was not found to be unsafe, but procurement was to be stopped until the manufacturer implemented corrective measures.
Reacting to it, Dr Rajesh Jain, joint managing director, Panacea Biotec, says, "There have been certain disruptions, but I am confident that we will bounce back in 2013. Our performance has been affected by the delisting of pentavalent vaccine from the WHO's list of pre-qualified vaccines, following a routine site audit by a WHO team in July 2011.We have initiated corrective and preventive measures to ensure compliance with the WHO pre-qualification guidelines and are in touch with the WHO in this respect. We are confident that with these corrective and preventive measures, our pentavalent vaccine will regain its WHO pre-qualified vaccine status."
Bharat Biotech, one of the major exporters of vaccines to international organizations such as the WHO, too adheres to the highest quality standards. But, in 2011, the WHO suspended supply of its hepatitis B vaccine through UN procuring agencies after it found deficiencies in the implementation of good manufacturing practices and quality management of the company during a site audit of a production plant at Hyderabad. The WHO, however, did not recommend recall of Revac-B+ that was already distributed, since the suspension was precautionary and an interim measure.
Regulatory landscape requires reforms
Delay in approvals after submission of dossiers to regulators is a pain point for the industry. Mr Chinny Rao of Transgene Biotek says that advantages of manpower availability and lower costs of manufacturing, which gives the industry in India its underlying momentum, can sometimes get "outweighed by certain localized disadvantages, most of which typically relate to bureaucracy".
Biologics manufacturers are striving hard to adhere to international quality standards. Better regulatory policies by the government will go a long way in aiding the industry