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Brazil, one of the key export markets in Latin America for Indian pharma companies, is reviewing the proposal to allow Indian laboratories to conduct bioequivalence tests, necessary to grant product approvals in that country. Senior officials from the Brazilian regulator ANVISA are likely to interact with their counterparts in India to take the process further.
According to senior officials in the Pharma Export Promotion Council (Pharmexcil), a recent delegation from the Union ministry of commerce and industry which had been to Latin America, had met ANVISA officials. “We had highlighted the issues related to delays in drug approvals in Brazil,” said P V Appaji, director general of Pharmexcil.
He further explained that the Brazilian authorities off late have been pressing for bioequivalence tests required for getting drug approvals in country be done in Brazil only. “We have suggested that they allow Indian laboratories to conduct the necessary tests as most other countries allow that. This would save significant amount of time and logistical delays,” Appaji claimed. In response to this suggestion from India, the ANVISA officials have expressed their desire to interact with officials in the Central Drugs Standard Control Organization (CDSCO) in India.
A senior government official who was part of the delegation informed that officials from the ANVISA, the national health surveillance agency of Brazil, might soon visit India to interact with CDSCO officials. “The ball has been set in motion. Things are moving very fast,” he claimed.
Last year Brazil had suspended new applications for medicine registrations with bioequivalence certifications issued by clinical research centres located outside the country. The move is expected to add to delays in getting new products registered in Brazil, which is considered amongst the biggest drug markets in Latin America. According to industry sources, such a requirement can increase the product approval time from an already lengthy 36 months to 48 months.
Bioequivalence tests broadly refer to tests done to assess the ‘interchangeability’ between generic and innovator drugs so that efficacy of the generic product is established. It basically tries to assess whether the efficacy of the generic version is comparable to the safety and efficacy of the corresponding innovator drugs.
The move made by Brazilian authorities was significant, as delays in product approvals could affect business prospects in the world’s sixth largest pharmaceutical market which is expected to grow at 11-15 per cent CAGR till 2017. Domestic companies like Torrent Pharmaceuticals, which have significant presence in Brazil, are likely to benefit if ANVISA relaxes norms.
Torrent already has around 15 products in the Brazilian market and has 25 products under approval. The company expects around three product approvals to come in during the current fiscal.
