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Brazil’s acceptance of GMP certificates issued by PIC/S countries for drug registration augurs well for Indian exporters
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Laxmi Yadav, Mumbai
July 31 , 2020
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The Brazilian health regulatory agency ANVISA’s acceptance of GMP certificates issued by member countries of PIC/S for registration of active pharmaceutical ingredients (APIs) and drugs; and also the relaxation in requirements for the presentation of certificates of origin during COVID-19 pandemic have augured well for Indian drug exporters.
India is a leading exporter of pharmaceutical products to the Latin American country. In 2019-20, India exported pharmaceuticals worth US$ 297 million to Brazil.
Given the gravity of the current situation, Brazilian National Health Surveillance Agency (ANVISA) has adopted alternative certification procedures based on remote inspection or reliance on data from other health authorities.
As per the resolution of the Collegiate Board (Resolucao da Diretoria Colegiada – RDC) of ANVISA dated March 13, 2020, Brazilian health regulatory agency will accept GMP certification, based on reports issued by member countries of the Pharmaceutical Inspection Cooperation Scheme (PIC/S) even in cases where the company is not based in a country which is part of the scheme, for registration and post registration of APIs, drugs and health products in the country.
The March 13 resolution established extraordinary and temporary criteria and procedures for GMP certification for registration and post registration of APIs, drugs and health products in Brazil during COVID-19 pandemic.
For the certification of healthcare products, information from the Medical Device Single Audit Program (MDSAP) is accepted by ANVISA.
MDSAP allows a single audit of a medical device manufacturer's quality management system which satisfies the requirements of multiple regulatory jurisdictions such as Australia, Brazil, Canada, Japan and the United States. Audits are conducted by Auditing Organizations (AO), such as Bureau of Indian Standards (BSI), authorized by the participating regulatory authorities (RA) to audit under MDSAP requirements.
For certifications related to pharmaceutical inputs (APIs), the resolution has allowed the acceptance of results from the “Program to rationalize international GMP inspections of API manufacturers”. The programme has been implemented as an international cooperation among regulators in order to improve efficiency and effectiveness of GMP inspections.
In addition to these alternatives, the resolution also allowed certification based on remote audits carried out by ANVISA.
With regard to acceptance of studies of safety, efficacy and quality for drug registration, ANVISA has informed that the resolution dated March 17, 2020 established special procedures for drug registration that has specific therapeutic indication for the prevention or treatment of COVID-19 and the drug can be useful in the clinical management of the disease or contribute to lessen the burden on the national health system.
Such special procedures include flexibility of evidence and prioritization of analysis. The resolution also allowed registration of anti-COVID drugs marketed in member countries of PIC/S in Brazil prior to bioequivalence study of the medicine in the country.
With reference to the requirement for printed documentation to import goods into Brazil, the Ministry of Economy has eased the requirements for the presentation of certificates of origin during emergency situations, state of public calamity or a pandemic declared by the WHO, extending the deadline for the presentation of the certificate to 60 days after the import declaration is registered. The flexibility was determined by means of the Normative Instruction No. 1936, dated April 15, 2020.
Pharmexcil has sensitized member exporters to above alternate procedures adopted by ANVISA in the wake of coronavirus to help them continue exports to Brazil seamlessly.
Welcoming the alternative certification procedures adopted by ANVISA for product registration amid COVID-19 pandemic, Sahil Munjal, vice chairman, Pharmexcil said “India has a significant number of drug plants approved by UK Medicines and Healthcare Products Regulatory Agency (UK MHRA) which is a member of PIC/S. Thus Brazil’s acceptance of GMP certificates issued by member countries of PIC/S will be beneficial to Indian exporters.”
Munjal further stated that the ANVISA has fast tracked registration of COVID-19 drugs. The waiver of bioequivalence study for registration of COVID-19 drugs marketed in the US and Europe with ANVISA has augured well for Indian exporters. Earlier it was mandatory for drug exporters to conduct BE study on drugs in Brazil to register them with ANVISA. With the relaxation in norms, the exporters can register COVID-19 drugs with ANVISA provided that the BE study of the drugs has been conducted in the US and Europe. Later they can submit local BE study data to ANVISA.
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