Bio Farma has come under the lens of Indian drug regulator CDSCO as it supplied bulk vaccine or key starting material to Biomed.
Indonesian vaccine maker Bio Farma has denied any contamination of oral polio bulk vaccine supplied to Indian company Biomed with phased out polio type 2 virus strain. The rebuttal comes as 1.5 lakh contaminated vials of a polio virus strain are suspected to have entered the government's immunisation programme.
"Bio Farma has proactively investigated the matter internally comprising among others batch review, facility assessment and testing of retain samples of all bulks shipped to Biomed using validated test method," the company told Moneycontrol in an email on Friday.
"Results have shown that there have not been any discrepancies in the manufacture of these bulks. Test results of retain samples do not indicate presence of type 2 polio virus," the company added.
Bio Farma said it has forwarded a letter to Biomed, seeking the chronology of events and details of the problematic polio bulk batches. "Polio bulks of the same batches have also been shipped to our other partners as well as utilised by Bio Farma with no complaints of the kind," the company said.
Bio Farma came under the lens of Indian drug regulator Central Drugs Standard Control Organisation (CDSCO) as it supplied bulk vaccine or key starting material (KSM) to Biomed.
Biomed supplied around 1.5 lakh vials of oral polio vaccine contaminated with long-eradicated type 2 polio virus putting India's polio-free-country status at risk and has left millions worried about their children's health.
KSM here refers to the polio live attenuated (weakened) virus strains that go into the making of vaccine.
The investigation conducted by CDSCO on the premises of Biomed's facility failed to reveal the source of the virus.
This led the CDSCO inspectors to suspect that the source of contamination may have originated from Bio Farma. Indian drug inspectors are now headed to Indonesia for further investigation.
Biomed procures the bulk vaccine from BioFarma, formulates it into a finished product, and supplies it to the government's National Immunisation Programme, and exports it to other countries.
Bio Farma is a World Health Organisation (WHO) prequalified vaccine manufacturer of oral polio vaccine. The company is one of the largest suppliers of polio, producing at least 1.4 billion doses of oral polio vaccines.
Even other Indian companies like Panacea Biotec, Bharat Biotech and Bharat Immunologicals & Biologicals import bulk polio vaccines from BioFarma, as they compete for government contracts to supply the vaccine at the lowest price.Bio Farma said it implements a comprehensive quality management system complying with current Good Manufacturing Practice and Good Distribution Practice.