|
Ref: PXL/H.O./CIR-042/2015-16 Date: 16.07.2015
|
Revised MAI Scheme
Additional financial components for Pharma Industry
|
To
All the Members of Council,
Dear Sir/Madam,
As members may be aware, Government has revised the MAI scheme with effect from 4.8.2014 incorporating some additional components for Pharma industry, which is placed in our website. Highlights of the additional components are given below;
-
Reimbursement of 50% of DMF, ANDA fees paid foreign regulatory authorities
-
Reimbursement of 50% expenses incurred on Bioequivalence tests conducted, subject to some prescribed conditions.
-
Reimbursement of 50% of Patents filing expenses , provided the patent is owned and assigned at Indian soil and subject to a minimum 75% ownership is with Indian public/promoters
-
Reimbursement of costs associated with travel and stay of visiting inspectors of foreign regulatory authorities for inspection of facilities, subject to a ceiling of Rs.75,000/- (Rs.1.00 lakh in case of American continents) per official.
(All reimbursements not exceeding Rs 50.00 Lakhs per annum).
To view the complete details of above components, please click here.
While many members are utilizing the reimbursement of 50% of DMF, ANDA filing expenses, other components like reimbursement of expenses incurred for bioequivalence tests, patent filings and travel expenses for inspectors could not be implemented / utilized by members due to some ambiguity in the scheme.
In this connection, we wish to inform that we have already taken up with the Department of Commerce to review and revise the conditions for stipulated in case of reimbursement for some expenses incurred in cases like Bio equivalence studies / patent filings / visit of regulatory officials for inspection of facilities (inspection fees not included!) etc. Pending further clarity on these items, members are advised to submit applications by claiming 50% of actual expenses incurred. Pharmexcil will examine and recommend applications to DoC for appropriate decisions.
Members may contact us for any further clarifications.
Dr. P V Appaji
Director General
Encl:
Revised MAI
|
