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Pharmexcil modifies dates for eligibility criteria for filing MAI claims for product retention in 4 African nations & Switzerland
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Laxmi Yadav, Mumbai
March 16 , 2022
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The Pharmaceuticals Export Promotion Council of India (Pharmexcil) has modified reference dates for calculating eligibility criteria for submitting claims under the Market Access Initiative (MAI) scheme for retention of products for Kenya, Tanzania, Switzerland, Uganda and Zambia considering the constraints faced by the applicants.
The date of invoice and date of payment receipt will be considered as reference date for calculating 45 days for all the MAI claim applications for retention of the product where the regulatory agency is not issuing retention certificates.
Under MAI scheme, a company can also avail the benefit of reimbursement of 50 per cent expenses incurred towards product retention charges apart from product registration charges and all applications need to be submitted on-line, within 45 days from the date of issue of product registration certificate for getting the claim benefit. Earlier members were required to submit claims under the scheme in 90 days from the date of issue of registration certificate.
The MAI scheme has been implemented by the ministry from 2003. The ministry extended the scheme for a period of five years from April 1, 2021 to March 31, 2026.
The product registration certificates, re-registration and renewal certificates issued by the overseas drug regulatory authorities are clearly reflecting the date of issue of certificate, said Uday Bhaskar, director general, Pharmexcil.
It is observed that few of the drug regulatory authorities viz Kenya, Tanzania, Switzerland, Uganda and Zambia do not issue product retention certificates despite making payment for annual retention. It has become a challenge for applicants to provide the evidence of granting the retention certificate and the reference date required to initiate MAI claims, said Bhaskar.
Hence, in case of Uganda, Tanzania, Zambia and Kenya, where the regulatory agency is not issuing a product retention certificate, the payment receipts issued by the overseas regulatory authority for retention of the products will be considered as a reference document for calculating the stipulated timeline for submitting the MAI claim applications, he said.
In the case of Switzerland where the product retention certificates and receipts are not issued by the regulatory agency, invoices will be considered as the reference document for calculating the eligibility criteria for submitting the claims, he stated.
Member companies have been asked to submit the claims considering the above reference documents for calculating the defined timelines (i.e 45 days), added Pharmexcil director general.
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