ANVISA passed Kemwell’s manufacturing facility for oral solids in Bangalore, India following a recent inspection. The site will now be allowed to manufacture J&J’s TB drug Sirturo (bedaquiline) for the Brazilian market. The facility already makes drugs for the EU, US, Canada, South Africa, and Australia.
“The [US] FDA is tough but ANVISA is considered the toughest regulatory agency with respect to audits,” Ashok Hegde, Kemwell’s VP, Pharmaceutical Operations, told this publication.
“Every inspector has its own methodology of auditing. The FDA mostly concentrates on the documentation part. If an audit lasts five days, four of those will be spent on documentation.
“But ANVISA is exactly the opposite – it spends most of its time focusing on the facility and live operations. They will ask you to demonstrate things about the manufacturing procedure.
“They want to be on the ‘shop floor’ when manufacturing is going on – to see how you do granulation or a tabletting procedure. They want to witness everything.”
The US and Brazilian agencies also differ in their warning notice. Since the FDA opened several offices in India in the last four years, around 12 inspectors have been based in the country and can schedule inspections at short notice. “They will call you on Friday and say they’re coming on Monday,” said Hegde. ANVISA typically gives four weeks’ warning, he said.
Brazil has historically had tight rules about pharmaceutical imports. Hegde said few foreign manufacturers are approved by ANVISA, and the region prefers home-made products or drugs imported in bulk and then packaged for consumers in Brazil.
But the country is growing as a market for complex, high-quality drugs. Hegde pinpointed injectables, especially biologics, and third-generation antibiotics like cephalosporin as “the next segments where demand is going to pick up.”