New Delhi: The National Pharmaceutical Pricing Authority (NPPA) has directed that if the pricing of a new drug formulation for which the Multidisciplinary Committee (MDC) of Experts has already recommended a price, the Authority can follow the same methodology for similar applications from a different applicant without seeking advice of the Committee in each case.
The decision was taken in a recent Authority meeting after detailed deliberations regarding the recommendation of the MDC 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.
“The Authority deliberated and accepted the recommendation of the MDC. The Authority directed that pricing of subsequent applications of the formulation which has already been placed in MDC once may be done on the methodology adopted by MDC for that formulation,” said the drug price regulator.
“Hence, retail price of such formulation may be worked out and the draft working sheet may be uploaded on the website for comments, if any as is done for other cases of retail price fixation. This will allow MDC to focus on other important issues rather than looking at routine matters,” it added.
The MDC in a meeting on August 8, 2023, observed that in some cases, similar procedure is being followed for fixing the price of same formulations with only change of month when a new application is received. The retail price recommended in earlier meetings for a particular formulation for a specific company is being placed again before the MDC with data of the new month for a new applicant.
“Since, the basic methodology followed is same and only the data of calculation 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,” said the MDC.
“Accordingly, MDC recommends that the matter may be placed before the Authority for consideration,” it added.
As a practice, the applications for retail price fixation of the new drugs for which market-based data is not available are placed before MDC as per provisions under the Drugs (Prices Control) Order, 2013 and the prices recommended by the Committee are placed for approval of the Authority.
In the previous meeting, the NPPA considered the recommendation and decided to further discuss it before taking a decision. The Authority observed that as per the present practice, if the data of requisite month, that is the data of the month ending immediately before six months or receipt of application is not available in Pharmatrac, such cases are referred to MDC even if, the price of same formulation has been fixed earlier for other applicants based on recommendation of the Committee.
“The retail price calculated may be different from the earlier recommended price for other applications due to change in data to be considered i.e., six months prior to the date of application,” said the Authority while considering the MDC’s recommendation.
Based on this observation, the NPPA decided that the matter needs further deliberation.
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.
