Indian pharmaceutical exporters to Brazil are in distress with unexpected changes taken place in the county's bio-equivalence norms by its regulatory authority, ANVISA, last year. Conforming to the new norms, Indian exporters had to conduct bio-equivalence (BE) studies all over again for several products, even to certain products which were already registered by them.

It takes a minimum of 3 to 4 months for a product to be registered after finishing BE studies. According to sources, on an average, every Indian company had to reconduct BE studies on six products.

The companies that were affected include exporters like Glenmark Pharma, Sun Pharma, Unichem, Medley Pharma, Ranbaxy, Dr Reddy's Labs and Cipla.

Among changes, it has been made mandatory that CROs used for BE studies have to be approved and certified by the Brazilain authority. Previously, certification from the regulatory authority was not mandatory, according to sources.

Moreover, ANVISA has stressed upon the usage of innovator's sample manufactured in Brazil for comparison with the generic (exporter's) molecule, in the stability and the dissolution profile studies involved in BE.

Previously, a sample manufactured anywhere in the world could be used for comparison, according to Dr Satish Bhatia, president, Wellquest Clinical Research, CRO division of Nicholas Piramal India Ltd (NPIL). Dissolution profile analyses the dissolution of a generic in stomach.

Wellquest is one of the ANVISA certified CROs in the country. Currently, six Indian companies have tied up with it for conducting BE tests for Brazil.

"It is now mandatory to use same innovator's batch throughout the series of bio-equivalence studies," he said. Even the excipients' profile in the generic has to match with the sample from Brazil.

ANVISA of Brazil is the most reputed regulatory authority in the Latin American pharmaceutical market. The agency constantly updates its regulatory requirements as per the latest international standards.

The Brazilian government policy today is more generic friendly. Generics currently contribute towards 30 per cent of the pharmaceutical market in that country. Few years back, generics had a share of just 5 per cent, according to sources, which is good news for generics exporters from India.