Brazilian drug regulator to consider relaxing norms for Indian firms

Sohini Das  |  Business Standard | Ahmedabad | 19 September 2014


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.

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