Drug Regulatory Authority Forms Team to Investigate Decline of Polio Vaccine

New Delhi: The Central Organization for Drug Control (CDSCO) on Saturday set up a three-member team to look into a recent case of contaminated polio vaccine.

Traces of poliomyelitis virus type 2, a strain known to have been eradicated from India, have been found in some lots of oral polio vaccine (OPV) manufactured by Bio-Med Pvt in Ghaziabad. Ltd, posing a serious threat of polio resurfacing in India.

"The three-member team will begin its investigation on Wednesday to identify the possible cause of the contamination," said a senior official at the Ministry of Health, asking for anonymity.

The company on its website positions its polio vaccine as one of its "flagship brands" and claims to conduct rigorous "pharmacovigilance activities" related to detection, assessment, understanding and control. prevention of adverse effects or other problems related to vaccines. Ensure the security.

Officials said, however, that the company's conduct raises suspicions. "Bio-Med is the main contributor to the polio vaccine. They may want to keep it alive. India eliminated the Type 2 strain in 2016. As a result, Poliomyelitis Vaccine Type 2 (ToPV) was eliminated in April 2016. The company was supposed to have destroyed the trivalent vaccine lots at ToPV, which may not have been done at the present time. Case. Many reasons could have led to contamination and a thorough investigation is needed. Three members will investigate and discover the cause of the contamination, "said the official.

The company was providing polio vaccines only for the government-run vaccination program and about 50,000 vials (one vial containing 20 doses) of contaminated vaccines could have been used in Uttar Pradesh, Maharashtra and Telangana. Instructions were given for removal of the vaccine manufactured by Bio-Med and recalled batches were sent for analysis to the Central Drugs Laboratory (CDL), Kasauli. "The unused vials were stored in the warehouses and 13 batches of samples were tested until now at CDL," said the second manager.

The ministry has contacted other companies such as Bharat Biotech and Panacea Biotec to ensure that vaccines are not lacking.

After years of efforts, India has been very successful in its fight against polio and was finally declared polio free in 2014. The last case was reported on January 13, 2011 when Howrah's Rukhsar was infected with the polio virus type 1. However, the possibility of resurging the polio virus has always hovered over the country. "This case can not be taken lightly and suggests the possibility of this threat returning to India. What needs to be looked at is the checks and balances system of the Department of Health. All samples are sent for analysis to the Kasauli government laboratory. Why was the strain not detected in the tests? Asked a public health expert, asking for anonymity.

The contamination was uncovered about 15 days after the World Health Organization (WHO) found traces of the virus in stool samples, according to surveillance reports in Uttar Pradesh. Samples were sent for further testing and confirmed type 2 virus contamination.

As part of the intensive monitoring, wastewater samples are collected from 45 sites in eight states and tested for poliovirus in five accredited laboratories in the country. This is in addition to stool samples taken from people reporting the sudden onset of paralysis or other symptoms similar to those of polio. Every year, nearly 75,000 stool samples are collected and tested in polio laboratories in India.

"It is at this point that the WHO has found the type 2 polio vaccine virus in some samples of sewage and stool during their routine surveillance," said the official. l & # 39; WHO.

"This detection indicates the use of a vaccine containing a type 2 poliovirus, despite the fact that the type 2 polio vaccine (trivalent oral polio vaccine) was eliminated globally and in India in April 2016, in the program. End-of-game polio strategy. As elsewhere, the bivalent oral polio vaccine (bOPV) has replaced trivalent OPV (tOPV) in all polio and routine immunization campaigns in India, "said a senior official. 39; WHO.

The chief executive of Bio-Med was arrested Friday after the central drug regulator filed a FIR in this case. "The other directors, who are family members of the director general, have been fleeing since," said the second official of the aforementioned ministry.

Calls on Bio-Med's landline phone outside office hours were not answered.

The decision to switch from tOPV to bOPV was taken following the certification of global eradication of wild poliovirus type 2. The elimination of the type 2 component of polio vaccine was carried out with the aim of minimizing the risk of type 2 poliovirus derived from the vaccine.

"India continues to conduct mass polio immunization campaigns, using bOPV, as advised by the Indian Expert Advisory Group, to maintain high immunity against polio." ", said a WHO official.