New Delhi: India’s drug regulator has asked Panacea Biotec Ltd to stop selling an oral polio vaccine (OPV) on recommendation by the World Health Organization (WHO).
“The suspension is on all the monovalent OPV1s (mOPV1s) manufactured by the company,” an official at the Drugs Controller General of India (DCGI) said on condition of anonymity. “However, this is a precautionary measure and further investigations are being conducted,”
In late 2008, a WHO test of a sample showed that Panacea’s mOPV1s—which fight against a single strain of polio—didn’t have the required potency.
“These results were confirmed by two independent WHO-contracted national control laboratories in Europe in February 2009,” a WHO spokesperson told Mint by email.
An official of the vaccine procurement department of the ministry of health and family welfare confirmed that the stock in question had been quarantined by the company.
“Any batch found to be not of standard quality (by WHO) needs to be banned both for domestic sale and export so that it is not administered to children in India and abroad,” said Chandra M. Gulati, a regulatory expert and editor of the Monthly Index of Medical Specialities.
DCGI, with assistance from WHO, is now working with Panacea to identify the reason for the inadequate potency found in a batch of OPVs it made in mid-2008, WHO spokesperson said.
“The batch under question was part of a clinical study which was duly cleared for use by our NRA (national regulatory authority, or DCGI). The issue is still under investigation with WHO and our NRA,” Rajesh Jain, joint managing director of Panacea, said by email.
“We believe, on the basis of data available with us, that our product continues to comply with WHO pre-qualification and NRA requirements,” Jain added.
Being a WHO pre-qualified vaccine supplier enables Panacea to export its vaccines to other countries. It supplies OPVs through the United Nations Children’s Fund (Unicef).
As part of its pre-qualification process for vaccines purchased by UN agencies, WHO randomly tests some samples.
It is mandated to monitor continued compliance with specifications for vaccine quality and inform national drug regulators of its findings and recommend necessary action.
In India, Panacea’s mOPV1 and mOPV3 are procured by the government through the Unicef for its pulse polio programme. The programme uses all three types of OPVs—trivalent, monovalent one and monovalent three.
In 2008-2009, the Unicef bought 540 million doses of mOPV1 and 170 million doses of mOPV3 for supply in India.
The WHO, meanwhile, said in its email to Mint that India would not face any shortage of OPVs, since the government and its partner agencies are working together to ensure sufficient quantities of WHO-recommended and pre-qualified mOPV1 are available.
An analyst said Panacea had 70% of the market share for OPVs in India in 2007-2008. He declined being named as he is not authorized to speak with the media.
Panacea sold OPVs worth Rs333 crore in the nine months ended December.