The national pharmaceutical pricing authority (NPPA) has increased the retail price of anti-rabies immunoglobulin by 6.49% and fixed the retail prices of 39 new drug formulations used to treat hypertension, diabetes, HIV, cardiovascular diseases, eye disorders and other conditions under the Drugs (Prices Control) Order (DPCO), 2013.
According
to a gazette notification issued after the NPPA's 148th authority meeting, the retail price of anti-rabies immunoglobulin injection has been revised to ₹119.48 per ml from ₹112.19 per ml. The revised price is exclusive of goods and services tax (GST), wherever applicable.
The revision follows the authority's decision earlier this year to permit a 6.4956% annual increase in the ceiling prices of scheduled medicines included in the national list of essential medicines (NLEM), based on the movement in the wholesale price index (WPI).
Apart from revising the price of anti-rabies immunoglobulin, the regulator has fixed the retail prices of 39 formulations covering therapies for hypertension, diabetes, HIV infection, cardiovascular diseases, cancer, vitamin deficiency and ophthalmic conditions. The notified retail prices will apply to the manufacturers and marketing companies specified in the notification.
Among the key formulations, NPPA has fixed the retail price of the amlodipine, bisoprolol and telmisartan tablet—a three-drug combination used to treat hypertension—at ₹14.74 per tablet.
The retail price of the clopidogrel, aspirin and atorvastatin capsule, prescribed to reduce the risk of heart attacks and strokes, has been fixed at ₹6.37 per capsule.
For ophthalmic care, NPPA has fixed the retail price of nepafenac and moxifloxacin ophthalmic solution at ₹68.64 per ml.
The retail price of the HIV treatment combi-kit containing darunavir, ritonavir and dolutegravir tablets has been fixed at ₹330.40 per kit.
The notification states that manufacturers of these 'new drugs' cannot fix retail prices higher than those notified by the NPPA. Any other manufacturer launching the same formulation within 12 months of publication of the notification must also adhere to the notified retail price after complying with the prescribed filing requirements.
The regulator has also warned that manufacturers or marketing companies charging prices above the notified retail prices will be required to deposit the overcharged amount, along with applicable interest, under the provisions of the DPCO, 2013, read with the Essential Commodities Act, 1955.
In a separate decision, NPPA granted a five-year exemption from price control to Pneubevax 14, India's first 14-valent pneumococcal polysaccharide conjugate vaccine, developed and manufactured by Biological E Ltd.
The authority said the vaccine qualified for exemption under Paragraphs 32(i) and 32(ii) of the DPCO, 2013, as it is protected by a granted patent and meets the criteria applicable to new drugs developed through indigenous research and development.
Under the DPCO, a patented new drug developed in India and not manufactured elsewhere is exempt from price control for five years from the commencement of commercial production.
NPPA has directed Biological E Ltd to furnish details of the dates of commercial production and commercial marketing of the vaccine in India, along with the price to retailer (PTR) and the maximum retail price (MRP) fixed by the company.
Key Formulations Notified by NPPA
• Anti-rabies Immunoglobulin Injection (Bharat Serums and Vaccines Ltd)
• Amlodipine, Bisoprolol & Telmisartan Tablets (Ravenbhel Healthcare Pvt Ltd/Glenmark Pharmaceuticals Ltd; Ravenbhel Healthcare Pvt Ltd/Torrent Pharmaceuticals Ltd)
• Clopidogrel, Aspirin and Atorvastatin Capsules (Safetab Life Science/Alkem Wellness Ltd)
• Nepafenac & Moxifloxacin Ophthalmic Solution (Akums Drugs & Pharmaceuticals Ltd/Cipla Ltd)
• Combikit of Darunavir, Ritonavir & Dolutegravir Tablets (Emcure Pharmaceuticals Ltd)
• Netarsudil & Latanoprost Ophthalmic Solution (Pure and Cure Healthcare Pvt Ltd/Sun Pharma Laboratories Ltd)
• Imatinib Oral Solution (Beta Drugs Ltd)
• Tenecteplase (TNK-TPA) Injection (Boehringer Ingelheim India Pvt Ltd)
