Some of the Indian pharmaceutical exporters to Brazil have begun to supply 'similar' drugs instead of the conventional generics, it is learnt. This is done as a measure to by-pass the now mandatory bio-equivalence (BE) studies, which is not required in case of similars. As BE studies are a must for generics, a company has to spend $ 50,000 for BE on a single molecule, said sources.
Moreover, the Brazilian generics market has begun to suffer from value erosion due to commoditisation. 'Similars' is a nice way of retaining value of a drug as it can be prescribed only by a medical practitioner and cannot be bought from a pharmaceutical distributor as in case of a generic.
Similars are products that contain the same active agent, the same concentration and pharmaceutical form and are administered in the same way and with the same dosage and have the same therapeutic result as the branded drug. But similars do not have the same bioequivalence as the proven in reference drugs. As a result, BE is non-mandatory.
According to senior officials in Confederation of Indian Industry (CII), companies like Torrent Pharma and Ranbaxy have already started turning their generics into similars in Brazil.
"Torrent Pharma is actively marketing similars in Brazil. Ranbaxy and other major Indian exporters are following suit," said CII sources.
The Brazilian government began aggressively pressing for generics entry into the country, when it's manufacturing suffered as a result of the volatile currency. 'Real' is Brazil's official currency.
Btazil's currency ratio of 1:2 (1 dollar = 2 real) in 1999 has climbed to 1:4 in 2001. However, for the past three years, the ratio has remained stable at 1:3. Experts feel this ratio to remain steady in the long run.
As a result of the volatile situation, the domestic industry collapsed and the purchasing power of the people were hit drastically, which encouraged the government for more imports from abroad that included generics. The overcrowding of generics is resulting into commoditisation in categories like anti-infectives, claim experts.