New Delhi, Jul 10:To ensure uniform pricing of new medicines, the National Pharmaceutical Pricing Authority (NPPA) has fixed the retail prices of 39 new drug formulations under the Drugs (Price Control) Order (DPCO), 2013.The prices have been notified through a gazette notification issued by the Ministry of Chemicals and will be applicable exclusive of Goods and Services Tax (GST).Issued under paragraphs 5, 11 and 15 of the Drugs (Prices Control) Order, 2013, the notification prescribes the maximum retail prices for specified new drug formulations manufactured and marketed by companies named in the notification. Manufacturers will not be permitted to market these formulations above the notified retail prices.
The latest order covers medicines prescribed for diseases, including hypertension, cardiovascular disorders, diabetes, bacterial infections, epilepsy, eye disorders, pain management, HIV and certain cancers, thereby bringing several newly approved formulations under the price regulation framework.
Among the major formulations notified, the retail price of Amlodipine, Telmisartan and Metoprolol Succinate (Extended Release) Tablets has been fixed at Rs 12.03 per tablet. Amoxicillin and Potassium Clavulanate Dispersible Tablets (400 mg/57 mg) have been priced at Rs 27.31 per tablet, while Amoxicillin and Potassium Clavulanate Tablets (250 mg/125 mg) will carry a maximum retail price of Rs 19.53 per tablet.
For patients suffering from cardiovascular ailments, the notification fixes the retail price of Aspirin (75 mg) and Atorvastatin (20 mg) capsules at Rs 3.67 per capsule. The price of Aspirin, Atorvastatin and Clopidogrel capsules has been fixed at Rs 8.86 per capsule, while Atorvastatin and Clopidogrel tablets have been notified at Rs 14.87 per tablet for the 10 mg strength and Rs 15.01 per tablet for the 20 mg strength. Bisoprolol and Telmisartan tablets have been priced at Rs 10.83 and Rs 12.71 per tablet, depending on strength. The retail prices of Telmisartan-Chlorthalidone tablets have been fixed between Rs 11.80 and Rs 21.40 per tablet, depending upon dosage strength.
The notification also includes several anti-diabetic medicines. Dapagliflozin and Telmisartan tablets have been priced at Rs 19.30 per tablet. Empagliflozin, Sitagliptin and Metformin (Extended Release) tablets have been notified at Rs 14.88 per tablet for the formulation containing Empagliflozin 10 mg and Rs 17.17 per tablet for the formulation containing Empagliflozin 25 mg. The retail price of Glimepiride, Voglibose and Metformin (SR) tablets has been fixed at Rs 8.85 per tablet, while Sitagliptin, Metformin and Glimepiride tablets have been priced at Rs 11.75 and Rs 13.27 per tablet, depending on the formulation. Among paediatric and commonly used formulations, the retail price of Cetirizine Hydrochloride drops has been fixed at Rs 8.55 per ml, Clobazam Oral suspension at Rs 2.80 per ml, and Vitamin D3 oral solution at Rs 15.88 per ml.
The notification further fixes the retail price of Imatinib oral solution, used in the treatment of certain cancers including chronic myeloid leukemia, at Rs 59.61 per ml. Netarsudil and Latanoprost ophthalmic solution, prescribed for glaucoma, has been priced at Rs 362.57 per ml, while Nepafenac and Moxifloxacin ophthalmic solution has been notified at Rs 68.64 per ml.
Among high-value formulations, Tenecteplase (TNK-tPA) injection 50 mg, a thrombolytic agent used in the emergency treatment of acute myocardial infarction (heart attack), has been notified at a retail price of Rs 60,238.27 per vial. The notification also fixes the retail price of the Darunavir, Ritonavir and Dolutegravir Combination Kit, used in antiretroviral therapy for HIV infection, at Rs 330.40 per kit.
The NPPA has clarified that the notified retail prices are exclusive of GST, wherever applicable. Existing manufacturers introducing the same “new drug” within 12 months of the date of publication of the notification may market it at a retail price not exceeding the notified price, provided they submit Form I-A along with supporting documents through IPDMS 2.0 within one month of the product launch.
The notification also requires manufacturers to issue revised price lists in Form V through the Integrated Pharmaceutical Database Management System (IPDMS) and furnish copies to State Drug Controllers and dealers. Retailers and distributors are required to prominently display the updated price lists at their business premises to facilitate easy access for consumers. The NPPA has warned that manufacturers or marketing companies failing to comply with the notified retail prices or other provisions of the Drugs (Prices Control) Order, 2013, shall be liable to deposit the overcharged amount along with applicable interest under the provisions of the Essential Commodities Act, 1955, read with the DPCO, 2013.