Brazilian drug regulator Anvisa is considering a proposal by India's government to accept the results of bioequivalence tests conducted in India in order to speed up the marketing authorisation procedure.
IHS Life Sciences perspective | |
Significance | Brazil's health surveillance agency (Anvisa) is reviewing a proposal to allow Indian laboratories to conduct bioequivalence tests in India and not require separate tests to be conducted in Brazil in order to speed up the marketing authorisation procedure. |
Implications | The mere fact that Brazil is contemplating accepting the bioequivalence tests done in India as valid in the generics market shows the strong links between the two countries. It indicates the relevance of setting partnerships between emerging markets beyond the Latin America markets. |
Outlook | The Brazilian health regulatory authority is working on tightening approval regulations for small chemical drugs and biologics in order to achieve standards comparable to those set by the World Health Organization and European Medicines Agency. It is likely to err on the side of caution when considering relaxing marketing authorisation requirements. |
Brazil's Health Surveillance Agency (Anvisa) is reviewing a proposal to allow Indian laboratories to conduct bioequivalence tests in India and not be required to repeat them in Brazil in order to speed up the marketing authorisation procedure, reports the newspaper Business Standard. According to the source, India's Pharma Export Promotion Council (Pharmexcil) has reported that a delegation from the ministry of commerce and industry which had been to Latin America had discussed with Anvisa the proposal and the Brazilian health agency has expressed its desire to interact with officials in the Central Drugs Standard Control Organization (CDSCO) to gather details about the bioequivalence tests for generics done in India.
Bioequivalence testing in Brazil
Bioequivalence tests are conducted to assess whether the generic copy of a small chemical drug has an identical chemical structure and similar bioavailability as the originator. A demonstration of bioequivalence means the generic can be approved via an abbreviated procedure without the need to conduct clinical trials establishing the safety and efficacy of the active pharmaceutical ingredient – and could simply refer to such data being available for the originator reference product. In the Brazilian legal system, Resolutions 391 of 1999 and 103/2003 establish the procedures and requirements for the certification of research centres conducting bioavailability and bioequivalence studies for the purpose of registration of pharmaceutical drugs in Brazil.
Last year, through resolution RDC 37/13, Anvisa suspended new applications for medicines registrations with bioequivalence certifications issued by clinical research centres located outside the country due to the fact that Anvisa is studying a proposal to review the current regulation on Certification of Good Practices in Bioavailability and Bioequivalence of Medicines (RDC 103/2003, see Brazil: 14 July 2014: Brazil's Anvisa to review regulation on certification of good practices in bioavailability and bioequivalence of medicines).
Outlook and implications
The Brazilian regulatory authority is working on tightening regulations for the approval of small chemical drugs and biologics in order to achieve standards comparable to those set by the World Health Organization and European Medicines Agency. As part of the procedure of introducing a new regulation on bioavailability and bioequivalence practice, Anvisa could include the option to carry out bioequivalence tests as a general rule or it could keep the requirement but give a special exemption for Indian companies.
Furthermore, the mere contemplation by Brazil of accepting the bioequivalence tests done in India as valid for marketing authorisation purposes shows the strong links between the two countries. It indicates the relevance of setting partnerships between emerging markets beyond the Latin America markets such as the recently approved technology-transfer agreement between Brazil's Ministry of Health and Protalix (Israel; see Brazil - Israel: 7 February 2014: INPI approves technology-transfer agreement between Brazil's MoH and Protalix for Gaucher's disease treatment).
Similar proposals on access of Indian generics manufacturers were made recently in Argentina and Peru. The Argentine government adopted in August a resolution to allow imports of generics from India after a 12-year ban and the Peruvian government's exploration of India's medicines production and infrastructure is aimed at studying the loan-licensing system in the country (see Argentina - India: 26 August 2014: Argentine government allows generics imports from India after 12-year ban and India - Peru: 9 September 2014: Peru's government seeks to implement loan-licensing system with India's pharma industry).
If Anvisa decides to make an exception for Indian companies from the requirement to conduct local bioequivalence tests, there would certainly be a huge benefit for Indian generic manufacturers and almost certainly a significant outcry from generic producers in Europe, the United States, and other countries which may challenge Brazil's preferential treatment. A pushback from patients and physicians is also possible if any quality control issues emerge in relation to Indian-produced generics – and Brazil's government would certainly not want a safety scare setback to delay its efforts to boost generic utilisation.
There have been numerous quality control concerns over generic medicines produced in India in recent years, particularly in the United States, resulting in FDA penalties and approval delays for affected companies. In a bid to dispel concerns about the quality of Indian generics, the Drug Controller General of India recently published a surveillance report indicating that only 2.3% of 1,123 drugs sampled in the Indian market were found to be sub-standard (see India: 21 March 2014: DCGI finds 2.3% of drugs substandard as fear of Indian generics rebounds). However, given that the issues remain and that Brazil's generic market is still emerging, Anvisa is likely to err on the side of safety in our view and be very careful with relaxing marketing authorisation requirements for generics.