New Delhi: The World Health Organization, or WHO, has ended an effective embargo clamped on the procurement of new vaccines from India after carrying out a thorough audit of the national drug industry regulator, delivering a boost to local vaccine makers.
The Drugs Controller General of India, or DCGI, the national regulatory authority (NRA), had been disqualified by WHO in late 2007 in a decision that barred any new vaccines made by Indian manufacturers from receiving the global agency’s approval.
“So, from January 2008, no new applications for vaccines from India were accepted till the NRA qualified again. Wherever we were pre-qualified by the WHO to supply vaccines, they allowed status quo, but they disqualified us for new approvals,” said DCGI Surinder Singh.
All clear: DCGI Surinder Singh. Madhu Kapparath / Mint
DCGI was on 17 April “approved and qualified” by WHO in a decision that reversed the earlier move. DCGI was disqualified after it was found not “up to the mark” in the 2007 audit.
“Now, this qualification is a big thing for us and will once again allow us to pick up our exports,” Singh said.
A total of 13 auditors from the US food and drug administration, Belgium, France, Egypt, Thailand and the WHO headquarters in Geneva audited the Indian NRA between 13 and 17 April before qualifying it again.
The audit team was split into three. One team audited the Central Drugs Standard Control Organisation in New Delhi, one visited the Central Drug Laboratory, Kasauli, where the country’s vaccine testing is done, and the third conducted field visits to inspect how NRA handled adverse effects of vaccines.
WHO sets out six critical control functions on which NRA has to qualify, “and we scored almost 100% on all six indicators”, said Singh.
Vaccine manufacturers can obtain approval from NRA which is then submitted along with an application for pre- qualification of the vaccines to the WHO headquarters. Following this, a joint audit of the manufacturing facility is conducted by WHO and NRA before the vaccine receives final approval.
“The credit goes to the DCGI and the health ministry for turning things around in a matter of a year. This is welcome news for us,” said Sunil Bahl, director (business development) at the Serum Institute of India, the country’s largest vaccine manufacturer.
“Indian manufacturers who have new vaccines ready can now file their pre-qualification applications with the WHO,” Bahl added.
“In a sense, our credibility has been restored after the disqualification we faced in 2007.”
Vaccines that secure approvals are procured by the WHO and distributed across the world by the United Nations Children’s Fund, or Unicef.
The Indian vaccine industry is valued at around Rs2,000 crore, of which at least Rs1,600 crore is generated from exports. WHO procures 40-70% of the global supply of DPT (diphtheria, pertussis, or whooping cough, and tetanus) and the BCG (bacille calmette-guérin) vaccine against tuberculosis, and almost 90% of measles vaccine from India. India exports vaccines to 150 countries.
“The whole global security of vaccine supplies was at stake. WHO gets cheap vaccines from India and they need us as much as we need them,” said a senior health ministry official involved in the audit.
The decision paves the way for WHO to approve new vaccines made in India to combat pneumonia and meningitis, for instance, said the official, who didn’t want to be named.
A WHO official, who also didn’t want to be named, said the approval of DCGI would not only benefit manufacturers — “it is also beneficial for the reputation of the country.”