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Place applications before MDC if change in circumstances calls for deliberations: Expert committee
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Gireesh Babu, New Delhi
August 29 , 2023
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The applications for retail price fixation may not have to go through the scrutiny of the Multi-Disciplinary Committee (MDC) of experts with the National Pharmaceutical Pricing Authority (NPPA) if the basic methodology for the drug is the same and only data of calculations changes, opines the expert committee.
The suggestion was made by the MDC while considering the retail price fixation of an ophthalmic drug combination brinzolamide IP 10 mg+ brimonidine tartrate IP 2 mg + timolol maleate eq. to timolol IP 5 mg + benzalkonium chloride solution IP 0.2 mg, manufactured and marketed by Bengaluru-based Micro Labs Ltd, in its recent meeting.
The Committee, after recommending the retail price by calculating it through its methodology, observed that the retail price recommended in earlier meetings for a particular formulation for a specific company are being again placed before the MDC in case of a different applicant.
"Since, the basic methodology followed is the same and only the data of calculations changes, the Committee is of the view that for the formulations for which once the retail price is recommended by the MDC, other applications may be placed before the committee, when change in circumstances requires deliberations," it said.
"Accordingly, MDC recommends that the matter may be placed before the Authority for consideration," added the Committee.
The observation was made in the MDC meeting that was held recently, under the convenorship of Sanjay Kumar, Advisor (Cost).
The MDC has a mandate to provide consultation on all technical issues relating to pricing, launch of new drugs along with other ancillary provisions where more clarity may be required, and opine on matters referred to it by the NPPA in discharge of its functions.
It has the responsibility to deliberate and recommend its opinion on the claims of pharma companies about additional therapeutic features associated with any formulation and recommending separate ceiling price of scheduled formulations or retail price of a new drug with specified therapeutic rationale, considering the type of packaging or pack size or dosage compliance or content in the pack namely liquid, gaseous or any other form, in the unit dosage, conforming to Indian Pharmacopoeia or other standards as specified under the regulations.
It also has the powers to deliberate, interpret and recommend its opinion on the claims of pharma companies about additional pharmacoeconomics features associated with any formulation or active pharmaceutical ingredients and recommend its opinion on the technical related issues whether the drug is scheduled or non-scheduled on the basis of ingredients used in the formulation, among others.
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