In order to determine the ceiling prices for these scheduled formulations under the 2013 revision to Schedule I of the Drugs (Prices Control) Order (DPCO), the National Pharmaceutical Pricing Authority (NPPA) has requested the industry to provide the Price To Retailer (PTR) and Moving Annual Turnover (MAT) of a total of 139 formulations. The formulations for which the details were sought include abacavir tablet 60 mg, combination of abacavir 60 mg and lamivudine 30 mg, various strengths of acetylsalicylic acid, amikacin injection, activated charcoal, amoxicillin, combinations of artesunate and sulfadoxine pyrimethamine, barium sulphate, bendamustine hydrochloride, benzylpenicillin powder for injection, budesonide nasal spray, calcium foliage injection, cefadroxil tablet, cefazolin powder for injection, chlorhexidine solution 5%, clarithromycin tablet and capsules, among others.
According to NPPA, all relevant manufacturers and marketing firms have been asked to provide the Price to Retailer (PTR) and Moving Annual Turnover (MAT) in value terms for the month of July 2022 in the specified format. According to the office document issued by the Authority in this regard, the information was requested and must be affirmatively provided within seven working days. The manufacturers or marketing firms shall submit the necessary information, including the PTF for July 2022 and MAT for July 2022, as well as the name of the formulation, brand name, composition and strength, dose and specification. The Authority made it clear that the total sales from August 2021 to July 2022, MAT sales, excluding taxes, must be submitted for July 2022.
The Federation of Pharma Entrepreneurs (FOPE), the Organisation of Pharmaceutical Producers of India (OPPI), the Indian Drugs Manufacturers’ Association (IDMA), the Indian Pharmaceutical Alliance (IPA), the Federation of Lydian Chambers of Commerce and Industry (FICCI), and the Associated Chamber of Commerce (ASSOCHAM) have all received the request. After revising the Schedule to replace the National List of Essential Medicines (NLEM), 2015 with the most recent NLEM, 2022, the NPPA is now determining the ceiling pricing for the formulations listed in Schedule I of the DPCO, 2013. In the course of this effort, it has thus far set ceiling pricing for more than 650 formulas.
The Authority previously said that there are 954 formulations in 388 medicines that are covered by the updated Schedule I, including 56 newly added pharmacological formulations. Around 763 of the formulations from NLEM, 2015 are still in use, and there are a total of 819 distinct formulas for which ceiling prices need to be set. The number of formulations, however, may rise from 954 formulations to close to 1000 formulations in light of the expansions to the updated Schedule 1 and other factors.
According to the DPCO, 2013, the ceiling prices for the medications in Schedule I must be determined within 60 days of the schedule’s notice. The data available for the month ending immediately before six months of notification of revision in the first schedule shall be the data available for fixing the ceiling price of schedule formulation due to revision in the first schedule, contrary to general practise, the Authority used the data from July 2022, paying attention to the representations of the industry associations.
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