The National Pharmaceutical Pricing Authority (NPPA) has announced retail price regulations for 71 essential pharmaceutical formulations, including critical medications for cancer and diabetes treatment, under the Drugs Prices Control Order (DPCO) 2013. This regulatory action aims to enhance drug accessibility and affordability for patients throughout India.
Cancer Treatment Pricing
The most significant pricing decision involves trastuzumab for injection (375 mg), a crucial medication used in treating metastatic breast cancer and gastric cancer. Reliance Life Sciences' formulation has been capped at ₹11,966.64 per lyophilized vial. This pricing regulation directly impacts patients requiring this targeted therapy for HER2-positive cancers.
Antibiotic and Infection Treatment Formulations
The NPPA has established pricing for several critical antibiotic combinations used to treat life-threatening infections. A combipack containing ceftriaxone, disodium edetate, and sulbactam powder has been priced at ₹626 per vial. Another formulation from Tyykem containing the same combination for solution infusion is set at ₹515.50 per vial.
Additional antibacterial fixed dose combinations featuring ceftriaxone, disodium edetate, and sulbactam for infusion have been priced between ₹447 and ₹1,036.60, with specific formulations marketed by Tyykem Pvt Ltd and Blue Cross Laboratories.
Gastrointestinal and Other Medications
Torrent Pharmaceuticals' combination therapy for peptic ulcer disease, containing clarithromycin tablets, esomeprazole tablets, and amoxicillin tablets, has been fixed at ₹162.52 per kit. This combination targets Helicobacter pylori infections that cause stomach ulcers.
The pricing notification also includes Ringer Lactate solution (non-glass, dual port cap) from Cartel Lifescience, approved at ₹64.29 per pack, excluding GST.
Diabetes Treatment Formulations
The NPPA has addressed diabetes medication pricing comprehensively, including 25 anti-diabetes formulations containing empagliflozin combinations in the pricing updates. Additionally, various diabetes formulations containing sitagliptin as a component have been included in the new price list, though specific pricing details for these medications were not disclosed in the notification.
Regulatory Framework and Compliance
The NPPA notification specifies that manufacturers may add Goods and Services Tax (GST) only if they have paid or it is payable to the government on the retail price. This clarification ensures transparency in the final pricing structure for consumers.
To enhance price transparency and compliance monitoring, the NPPA has mandated that drug manufacturers issue price lists to dealers, state drug controllers, and the government. An NPPA official explained that "the order to display the price list is to allow citizens to cross-check whether the pharmacies are selling at the price fixed by NPPA or not."
The regulatory directive requires that "every retailer and dealer shall display the price list and the supplementary price list, if any, as furnished by the manufacturer, on a conspicuous part of the premises where he carried on business in a manner so as to be easily accessible to any person wishing to consult the same." This requirement extends to virtual and online platforms where retailers conduct business.
The NPPA, as India's government regulatory agency responsible for controlling and revising pharmaceutical product prices, continues its mission to ensure fair pricing across the country's healthcare system. This latest pricing notification represents a significant step toward making essential medications more accessible to patients requiring cancer treatment, diabetes management, and infection control therapies.
