Pharmexcil urges Centre to make reimbursement for BA/BE studies conducted in labs not accredited by NABL

Mumbai, September 1, 2022:

The Pharmaceuticals Export Promotion Council of India (Pharmexcil) has urged the Union Commerce Ministry to make drug manufacturers/ exporters eligible for reimbursement of expense on bioavailability and bioequivalence (BA/BE) studies conducted in laboratories lacking NABL accreditation under Market Access Initiatives (MAI) Scheme.

The BA and BE tests, conducted by exporters in India, are submitted to the drug regulatory authority for the registration of the pharmaceutical product abroad.
 
Currently, exporters are required to conduct BA and BE studies in laboratories approved by National Accreditation Board for testing and calibration Laboratories (NABL) to avail the financial assistance of maximum Rs. 2 crore or 50 per cent cost of the test under MAI scheme.
 
Speaking at “Reinvigorating India’s Pharma Exports: Awareness Workshop on Export Incentives” held by Pharmexcil in Mumbai on August 26, 2022, Lakshmi Prasanna, director (Regulatory Affairs), Pharmexcil said there are several laboratories having state of the art facilities and excellent track record lacking NABL accreditation. BA and BE studies conducted by exporters in these labs for registration of products abroad are not eligible for reimbursement of expenses under MAI scheme. We have raised this issue with the department of commerce and appealed to the department to consider reimbursement of expenses of exporters who conducted BA and BE tests in labs sans NABL accreditation under the scheme, she said.
 
The MAI scheme is an export promotion scheme envisaged to act as a catalyst to promote India’s export on a sustained basis.
 
Under the scheme the level of assistance for each eligible activity has been fixed. The scheme provides drug exporters 50 per cent reimbursement of expenditure incurred on statutory compliances in the buyer country. The maximum assistance offered under the scheme is Rs. 2 crore per annum. The expenses include registration cost, plant inspection cost, BA/BE studies, patent filing charges etc, quality certifications for natural products, implementation of barcoding.
 
Members can claim either product registration charges or BE study charges. The time-limit for submission of the claims by exporters to Pharmexcil is reduced to 45 days from the date of receipt of registration.
 
The scheme is focused on development and promotion of exports from the MSME sector, development of districts as export hub for the identified products and services, promotion of exports of the traditional products and services like Ayush, Yoga, Geographical Indications products and tribal products, development and promotion of exports from North Eastern Region (NER), Jammu & Kashmir, Ladakh and hill regions and empowerment and promotion of export activities of people belonging to the scheduled caste/scheduled tribe, women exporters, startups and export oriented entrepreneurs, self-employed and youth.Pharmabiz