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Challenges with Fixing the Ceiling Price Under the 2013 DPCO

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Regulating Pharmaceutical Prices in India

Part of the book series: India Studies in Business and Economics ((ISBE))

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Abstract

In the previous chapter, we elaborated on the design of the 2013 DPCO and the procedure used for fixing ceiling prices under the newly-adopted market-based approach. Although it may appear relatively simple, the determination of the ceiling prices is associated with multiple challenges related to data availability, data selection, data collection, and data analysis. The lack of sufficient data and the use of inaccurate data can result in a miscalculation of the ceiling prices and create confusion among pharmaceutical companies, NGOs, and consumers, and lead to several legal disputes. The effectiveness of the 2013 DPCO will be judged based not only on the extent to which prices of essential medicines decline but also by comparing the ceiling prices resulting from the market-based approach with those that would result from using a cost-based approach. Soon after the implementation of the 2013 DPCO, some industry observers argued that the ceiling prices set by the NPPA were much higher relative to those resulting from a cost-based pricing mechanism that was previously in place. They noted that the new policy “institutionalized the super profits” (Alexander 2013a). The profit margins under the new price ceilings were estimated to be over 1000% in some cases. Moreover, the NGOs blamed the government for not sharing the data it collects from IMS and for not collecting its own data and corroborating them with other alternative sources. Are the criticisms of the 2013 DPCO design and implementation valid? In this chapter, we take a quantitative approach to examining the challenges that arose in determining the ceiling prices based on the new design and in implementing the 2013 DPCO. We begin by documenting the cases in which the pharmaceutical firms contested the NPPA’s calculations and then present analyses to characterize the nature and extent of such disputes.

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Notes

  1. 1.

    The NPPA’s worksheet displaying their calculations for determining the ceiling price is available online at: http://www.nppaindia.nic.in/ceiling/press14june13/workingsheet-14-6-13.html

  2. 2.

    http://www.nppaindia.nic.in/ceiling/press21june13/workingsheet-21-6-13.html

References

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  • Alexander, J. (2013b, October 31). DoP asks NPPA to relook at ceiling price fixed for azithromycin under new DPCO. PharmaBiz.com

  • Alexander, J. (2013c, August 26). NPPA starts collecting info on prices of non-scheduled products directly from drug cos. Pharmabiz.com

  • Alexander, J. (2013d, July 3). DCGI allows cos to re-print revised prices on essential drugs already available in market. PharmaBiz.com

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  • PharmaBiz.com. (2013a, August 5). Delhi HC sends notice to centre on DPCO issue as more companies challenge new drug pricing. Available from http://pharmabiz.com/NewsDetails.aspx?aid=76991&sid=2

  • PharmaBiz.com. (2013b, September 12). Chemists, druggists for more representation. PharmaBiz.com

  • Rana, S. (2016, May 4). AIOCD urges NPPA to mandate cos to recall stock from trade for correction in MRPs. PharmaBiz.com

  • Shankar, R. (2013, June 26). NPPA formula for fixing ceiling prices of essential drugs under new DPCO confusing. PharmaBiz.com

  • Shankar, R. (2014a, July 15). ‘Price to retailer’ only basis for deciding ceiling price of a drug under DPCO: DoP. PharmaBiz.com

  • Shankar, R. (2014b, November 18). NPPA issues draft proposal for display of distinguishing mark & ceiling price of scheduled drugs on label. PharmaBiz.com

  • Shankar, R. (2014c, November 24). NPPA’s move to display distinguishing mark on labels about ceiling prices of scheduled drugs opposed. PharmaBiz.com

  • Shankar, R. (2015a, July 28). DoP asks NPPA to fix price of Nab Tortaxel injection as per provisions of para 5(1) of DPCO 2013. PharmaBiz.com

  • Shankar, R. (2015b, March 4). DoP directs NPPA to revalidate data on Cefotaxime 250 mg and 500 mg injections. PharmaBiz.com

  • Shankar, R. (2015c, February 16). DoP directs NPPA to revalidate data on ciprofloxacin HCl tablet 250 mg. PharmaBiz.com

  • Shankar, R. (2015d, June 3). DoP directs NPPA to revise prices of ilaprazole + domperidone capsules. PharmaBiz.com

  • Shankar, R. (2015e, February 17). NPPA rolls back proposal on display of distinguishing mark & ceiling prices of scheduled drugs on labels. PharmaBiz.com

  • Shankar, R. (2016a, April 18). NPPA clarifies on implementation of prices fixed and notified under provisions of DPCO, 2013. PharmaBiz.com

  • Shankar, R. (2016b, July 12). DoP asks NPPA to re-fix ceiling price of ‘Clotrimazole Cream 1%’ on review petition filed by Glenmark. PharmaBiz.com

  • Shankar, R. (2016c, December 12). DoP directs NPPA to adopt correct methodology in fixing ceiling price of ciprofloxacin 500 & 250 mg tabs. PharmaBiz.com

  • Shankar, R. (2016d, July 18). DoP directs NPPA to examine new data to review ceiling price of erythropoietin Inj 2000 IU & 10000 IU. PharmaBiz.com

  • Shankar, R. (2016e, October 21). DoP directs NPPA to re-fix and re-notify ceiling prices of “Cefotaxime 1 gm injection”. PharmaBiz.com

  • Shankar, R. (2016f, September 12). DoP directs NPPA to re-fix ceiling price of ‘Coagulation Factor VIII’. PharmaBiz.com

  • Shankar, R. (2016g, August 30). DoP directs NPPA to re-fix retail price of “azithromycin and dexamethasone phosphate eye drops 3 ml vial”. PharmaBiz.com

  • Shankar, R. (2016h, September 27). DoP directs NPPA to revise ceiling prices of “Paclitaxel injection, Carboplatin & Cisplatin” strictly as per para 4 of DPCO 2013. PharmaBiz.com

  • Shankar, R. (2016i, October 24). DoP quashes ceiling price of levoflexacin 500 mg by NPPA; directs to refix ceiling price as per DPCO. PharmaBiz.com

  • Shankar, R. (2016j, May 16). NPPA asks retailers not to return stocks if manufacturers provide current price list as per revised notified prices of drugs. PharmaBiz.com

  • Shankar, R. (2017a, February 6). DoP directs NPPA to re-fix retail price of teneligliptin 20 mg + metformin 1000 mg ER tablets. PharmaBiz.com

  • Shankar, R. (2017b, September 21). DoP asks NPPA to re-fix ceiling price of co-trimoxazole tablet after examining documentary proof submitted by Cadila Healthcare. PharmaBiz.com

  • Shankar, R. (2017c, May 3). DoP asks NPPA to refix prices of “Methotrexate 2.5 mg, 7.5 mg and 10 mg tabs” by considering only 8 formulations with SKU-wise MAT of more than 1% market share. PharmaBiz.com

  • Shankar, R. (2017d, October 3). DoP asks NPPA to take expert committee’s opinion for fixing ceiling price of methylprednisolone Inj 40 mg/ml. PharmaBiz.com

  • Shankar, R. (2017e, August 14). DoP directs NPPA to re-fix ceiling price of N-acetylcyseine 200 mg sachet. PharmaBiz.com

  • Shankar, R. (2017f, January 5). DoP directs NPPA to re-fix ceiling price of ondansetron 2 mg/ml injectables. PharmaBiz.com

  • Shankar, R. (2017g, June 1). DoP directs NPPA to re-fix ceiling price of Ranitidine 25 mg/ml. PharmaBiz.com

  • Shankar, R. (2017h, September 18). DoP directs NPPA to re-fix ceiling prices of clomiphene 100 mg and 50 mg tablets. PharmaBiz.com

  • Shankar, R. (2017i, August 31). DoP directs NPPA to re-fix the ceiling price of Furosemide injection. PharmaBiz.com

  • Shankar, R. (2017j, January 12). DoP directs NPPA to revise ceiling price of formulation methyldopa 500 mg tablet as per para 4(1) and para 6 of DPCO, 2013. PharmaBiz.com

  • Shankar, R. (2017k, November 11). DoP directs NPPA to take expert panel’s opinion on separate ceiling prices based on pack sizes of methylprednisole injection. PharmaBiz.com

  • Shankar, R. (2017l, January 4). NPPA fails to fix ceiling prices of coronary stents due to insufficient data. PharmaBiz.com

  • Shankar, R. (2017m, April 17). No provision in DPCO 2013 to differentiate consumer pack and dispensing pack while calculating ceiling price: DoP. PharmaBiz.com

  • Shankar, R. (2017n, April 27). Sun Pharma gets favourable review on carboxymethylcellulose drops 1% as DoP asks NPPA to re-fix ceiling price. PharmaBiz.com

  • Vijay, N. (2015, February 27). NPPA to discuss identification marks for drugs under ceiling price with trade, BDCDA wants red color on packs. PharmaBiz.com

  • Yadav, L. (2016, July 20). DoP agrees to AIOCD’s demand for allowing sale of drugs at pre-revised prices until their batch number expires. PharmaBiz.com

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Bhaskarabhatla, A. (2018). Challenges with Fixing the Ceiling Price Under the 2013 DPCO. In: Regulating Pharmaceutical Prices in India. India Studies in Business and Economics. Springer, Cham. https://doi.org/10.1007/978-3-319-93393-1_5

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