Initiating the process of re-fixing the ceiling prices of eight essential drugs, the National Pharmaceutical Pricing Authority (NPPA) has asked various pharmaceutical companies, which are involved in their production and sales, to submit their sales and pricing data.
The NPPA had fixed the ceiling prices for these drugs — Azithromycin + Dexamthasone Phospate, Chlorthalidone + Amlodipine, Tacrolimus, Coagulation Factor VIII, Fluconazone, Carboxymethylcellulose, Gemcitabine Hydrochloride + Filgrastim and Budesnide + Formoterol — in the time period of last two years.
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However, major pharmaceutical companies such as Ajanta Pharma, Baxter India and Ipca Labs had filed review applications against the ceiling prices with the Department of Pharmaceuticals (DOP). These companies pointed at various faults in the calculations done by NPPA while deciding the ceiling prices. The NPPA works under the DOP.
For example, Baxter India had told the DOP that even though it has a market share of more than 80 per cent for the drug Coagulation Factor VIII, its product’s price was not considered by the NPPA while deciding the ceiling price. “Currently, the ceiling price as per the mentioned order has been set at Rs 3,323 for 250IU dosage, taking into consideration Price to Retailer (PTR) of Intas Pharmaceuticals and Reliance Life Sciences,” Baxter India said in front of DOP.
A drug, which is not patented, can be manufactured by any pharmaceutical company under its own brand name. For example, Paracetamol is a drug that is sold by GSK India, Alkem Labs and Micro Labs under the brand name Calpol, Sumo and Dolo, respectively.
“All the concerned manufacturers/ marketers are requested to furnish further additional data/information if any, along with the supporting documents like copies of sample invoices to retailer,” said the office memorandum of NPPA dated November 18, 2017.
This office memorandum was in relation to four drugs – Azithromycin + Dexamthasone Phospate, Chlorthalidone + Amlodipine, Tacrolimus and Coagulation Factor VIII.
The NPPA has written separate letters to four companies — Claris Injectables, Cipla, FDC Limited and Fresenius Kabi India — in relation to four remaining formulations. The NPPA has asked these companies if they have observed the “distortion” in ceiling prices due to any difference in the drug’s package size.
“We request you to the following information…on whether there is any special feature on any product which makes this formulation different from others on account therapeutic benefit, and the rationale for the separate ceiling price,” the NPPA added in its letters – which were all dated November 18 – to the four companies.