India’s drug price watchdog NPPA revises prices of vitamins, anti-asthma medicines

India’s drug price regulator National Pharmaceutical Pricing Authority (NPAPA) has revised the prices 240 drug formulations through issuing a notification dated September 14, 2009.

NPPA is in charge of monitoring the prices of drugs sold within the country. NPPA periodically excercises its option to revise or fix the pricing of certain bulk drugs and formulation packs that come under Drug Price Control Order (DPCO) 1995 –a statute to regulate prices of essential drugs.

The Drugs Price Control Order (DPCO) 1995 is an order issued by the Government of India under Section 3 of the Essential Commodities Act, 1955 to regulate the prices of drugs.

NPPA often revises the prices of active pharmaceutical ingredients (API) and formulations under DPCO according to the fluctuations in the market prices of the raw materials used in drugs.

The drug regulator annually fixes the maximum retail price of medicines that contain any one of the 74 raw materials that are under the price control of the government, as per the Drugs Price Control Order.

The Order provides the list of price controlled drugs, procedures for fixation of prices of drugs, method of implementation of prices fixed by government and penalties for contravention of provisions among other things.

NPPA is vested with the powers for implementing provisions of DPCO.

Only 74 out of 500 commonly used bulk drugs are kept under statutory price control. All formulations containing these bulk drugs either in a single or combination form fall under the price control category.

The price is fixed after considering all possible costs in packaging, conversion and material costs, as well as the excise duty, by the NPPA.Costs involving packaging and conversion contribute about one-third of the price that consumers pay for medicines.

NPPA carries out the price-fixing exercise as a step to bring in uniformity of cost among all the formulations containing price-controlled drugs across the country.

However, NPPA used to give a free reign for those drugs, which do not come under price-control, allowing them to increase the price by up to 10% annually.

The 240 formulation packs for which prices were revised as the latest notification on September 14 included the formulations based on bulk drugs such as ascorbic acid (vitamin C) with combinations, theophylline with combinations (anti-asthma), rifampicin with combinations, acetyl salicylic acid (Aspirin) with combinations, salbutamol with combinations (anti-asthma), multivitamin, etophylline with combinations, metronidazole with combinations, cloxacillin with combinations, Aspirin with combinations, sulphadimidine, ibuprofen with combinations, dexamethasone with combinations, vitamin E with combinations, Solu Medrol/Depo Medrol/Medrol (methyl prednisolone), Daivobet (betamethasone), Lantus/Apidra (insulin), Vitalux Plus TR (multivitamin), Recosulin (monocomponent insulin), Lupisulin (monocomponent insulin), Beplex Forte Elixir (multivitamin), Calron (multivitamin), Naunehal Baby Tonic (multivitamin), Gamone (multivitamin) and Cinkara (multivitamin).

Earlier, on 9th September NPPA had revised the prices of five bulk drugs used in making medicines for pneumonia and pain killers.

NPPA has fixed the prices of bulk drug dextropropoxyphene napsylate and dextropropoxyphene Hcl at Rs 5,535 per kg and Rs 3,361 per kg, respectively. Dextropropoxyphene napsylate and dextropropoxyphene HCl are used in preparing medicines to treat mild pain and as local anaesthetics.

NPPA has revised the prices of anti-inflammatory drug naproxen and naproxen sodium at Rs 1,585 per kg and Rs 1,617 per kg, respectively.

The other antibiotic whose price was fixed by NPPA is cephazolin sodium. Cephazolin is used to treat a wide range of infections including pneumonia and other respiratory infections. NPPA has fixed the cefazolin price at Rs 3,361 per kg.

In May NPPA had revised prices of 296 formulation based on bulk drugs cloxacillin, salbutamol, doxofylline, vitamin C with combinations, vitamin E with combinations, gentamycin with combinations, metronidazole with combinations, erythromycin with combinations, betamethasone, iodochlorhydroxyquinoline (ICHQ), prednisolone, Pheniramine maleate, thiamine HCl, cloxacillin, chloroquine, ibuprofen, pseudoephedrine, sulphadiazine, chloroquine,famotidine, frusemide, doxofylline, lantus (Monocomponent Insulin),medrol/solumedrol (Methyl Prednisolone), Vitalux Plus, Levemir / Novorapid/Novomix (Insulin) and Dettol antiseptic (chloroxylenol with combinations)