Booster dose for pharma as Govt okays refund on foreign plant inspection

Commerce Ministry raises cap to Rs 2 crore a year per drug exporter from Rs 50 lakh under MAI scheme; 50% of costs incurred towards statutory compliance to be borne by firm

Pharmaceutical companies can now claim reimbursement of costs incurred on plant inspections conducted periodically by overseas regulatory agencies. 

The Union Commerce Ministry has revised the Market Access Initiative Scheme (MAI Scheme) along with guidelines related to reimbursement of expenditure incurred by Indian exporters on statutory compliance in the buyer country, while including additional components, besides raising the fund limit.

The Ministry has added plant inspection charges for pharmaceutical products as eligible for funding assistance under MAI, and has raised the ceiling to Rs 2 crore a year per exporter from the present Rs 50 lakh. According to the new guidelines, any exporting company can claim reimbursement of charges incurred towards statutory compliances on a 50:50 sharing basis up to a maximum amount of Rs 2 crore in a year.

Pharmaceutical Export Promotion Council (Pharmexcil) director general Udaya Bhaskar said irrespective of size, any pharmaceutical company that exports its products can claim reimbursement as per the revised guidelines.

Indian pharma companies will keep receiving the inspection teams of multiple drug regulatory agencies, including the US Food and Drug Administration (USFDA), for inspection of their plants or cGMP audit, which is necessary to get permission to export their products to the respective countries. These regulatory agencies will also collect a fee for a plant inspection. 

Companies will have to get the manufacturing site for a specified product or products approved for import by a country's regulator, such as USFDA, in order to be able to export to those countries.

In addition to the plant inspections, the Ministry also included the quality certification required for natural products such as herbal products, registration charges of cosmetics products, data generation and data evaluation costs for agrochemicals and cosmetics and the testing charges for export of engineering products under the MAI Scheme.