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The National Pharmaceutical Pricing Authority (NPPA), is an executive body under the Drugs (Prices Control) Order (DPCO), 2013 under Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Government of India. NPPA regulates drug prices and availability of the medicines in the country by fixing/revising the prices of controlled bulk drugs and formulations. The NPPA's key announcements/notices of February 2018 are apprised and described below:

1. NPPA has fixed/revised ceiling prices/retail prices of 30 formulations: On February 06, 2018, NPPA has fixed ceiling prices/retail prices of 30 formulations under DPCO, 2013. Amongst the 30 formulation included in this price fixation notice, included drugs are used for treatment of conditions like Pain, Infections, Hypertension, Epilepsy, Diabetes, Cancer etc. as described below -

2. NPPA releases clarification regarding partially revised format of Form – I: On February 05, 2018, NPPA released clarification regarding partially revised format of Form – I for applications of new drug under Para 2(u) of DPCO, 2013. NPPA clarified that in order to expedite the retail price of new drug applications, the applicant company has been asked to indicate drug category as per the report of Kokate committee and Drug Technical Advisory Board (DTAB) to save time spent by NPPA on seeking this information from Drug Controller General of India (DCGI)17.

3. Analysis of Trade margin in Cardiac guide wire/Balloon catheter/ guiding catheter: On February 12, 2018, NPPA analyzed the trade margins in the Cardiac Guidewire/Balloon Catheter and Guiding wire based on available data from the official sources and manufacturer/importer as described below –

*MRP: Maximum Retail Price, PTD: Price to Distributor/Stockist.18

4. Revision of coronary stents price: On February 12, 2018,19 NPPA fixed and notified the revised ceiling prices of drug eluting stents (DES) from Rs. 29,600 to Rs 27,890, while marginally raising the cap on bare metal stents from Rs 7,260 to Rs 7,660, exclusive of goods and services tax applicable, if any. Whereas, any manufacturer intending to discontinue production or import of any Coronary Stent shall furnish information to the NPPA, in respect of discontinuation of production and / or import in Form-IV of Schedule-II of the DPCO, 2013 at least six months prior to the intended date of discontinuation as prescribed under paragraph 21(2) of the DPCO, 2013 and follow the ceiling price in such manner and till such a time prescribed by the Government. The revised ceiling price hereinabove shall be applicable till March 31, 2019 unless revised by another notification20.

5. NPPA has fixed/revised ceiling/retail prices of 09 formulations: On February 13, 2018, NPPA revised the ceiling prices of nine scheduled formulations under DPCO, 2013. The said formulations are used to treat a range of ailments from infertility in women to arthritis to seizures. The formulations included in this price revision are Clomiphene tablets, Adenosine injection 3mg/ml, Povidone Iodine Solution 10 percent(1 ml), Methylprednisolone injection 40mg/ml (1 ML), Sodium Valproate CR tablets 300 mg,& 500mg, Isosorbide 5 Mononitrate tablet 20 mg, and Lignocaine Topical Forms 2-5 per cent (1 gm or 1 ml)21.

6. Price analysis based on the complaints received by NPPA regarding overcharging in bills by four hospitals: On February 20, 2018, NPPA released Price analysis report after receiving complaints of overpricing and inflated bills from the relatives of deceased patients. NPPA, within its jurisdiction under Drug Prices Control Order, 2013 had asked for details of billing from these hospitals and analyzed the same in great detail.

The report suggests that the total expenditure on drugs and devices and diagnostics is substantially high (46%) and does not make part of the publicized 'estimate' or 'package'. This is a clear case of market distortion where manufacturers after accounting for their profits print inflated MRPs to meet the demands of a distorted trade channel without getting any benefits from this 'artificial inflation' and patients have to incur huge out-of-pocket expenditure in hospitalization cases. The major beneficiaries of profits in all these cases because of inflated MRPs have been hospitals rather than drugs and devices manufacturers. The violation of ceiling price and corresponding MRPs is detected only in very few cases which shall be pursued further by NPPA for recovering the overcharging amounts from defaulters22.

7. NPPA fixed/revised ceiling/retail prices of 14 formulations under DPCO 2013: On February 27, 2018, NPPA fixed/revised the retail/ceiling prices of 14 scheduled formulations under DPCO, 2013. The revised formulations are used for the treatment of diabetes, hypertension, cancer and Hyperlipidemia etc. as described below-

17. http://www.nppaindia.nic.in/order/om_revisedformat(09022018).pdf

18. http://www.nppaindia.nic.in/order/trade_margin(Catheters).pdf

19. http://www.nppaindia.nic.in/order/revised_prices(coronary-stents).pdf

20. http://www.nppaindia.nic.in/minutes/minutes-2017-18/Authority_minutes.pdf

21. http://www.nppaindia.nic.in/ceiling/press13feb18/Formulation_Prices(09).pdf

22. http://www.nppaindia.nic.in/order/overcharging_details(20022018).pdf

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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