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India may bring vaccines under price control: Reports

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Wednesday, May 12, 2010, 18:16 This news item was posted in Biotech, Featured category and has 0 Comments so far.

India is likely to bring in all kinds of vaccines under drug price control, reports indicate.

Indian  government has already outlined the draft guidelines for new national vaccines policy to bring all kinds of vaccines under the purview of the Drugs Price Control Order (DPCO)  inorder to ensure stable and affordable supply of vaccines to the national immunization programme.

Pricing of all vaccines should be brought under the Drug Price Control Order (DPCO) and subjected to regulation in accordance with the objectives of this policy. Pricing of vaccines should be done on a transparent basis and agreed principles of reasonable returns on investment, rates of royalty and costing of R&D efforts, reports said quoting the final draft of new vaccine policy.

Vaccines should also be exempted from certain duties and taxes such as excise duty, value added tax (VAT), customs duty etc.

The difference between maximum retail price (MRP) and the price at which vaccines are supplied to wholesalers, retailers, hospitals or even to doctors will also be minimized to deter monetary incentives for unethical vaccine promotions,” according to the final draft.

All the essential vaccines covered under universal immunization programme (UIP) such as TT, DT, DTP, BCG, polio, measles must continue to be produced by the public sector.

The policy aims to ensure to everyone in need and to achieve national self-reliance in vaccine R&D as well as to maximize the national benefits of international sharing of indigenous biological diversity of pathogens, hosts and knowledge, to the Indian end-users of vaccines on terms that are fair and just.

Vaccination should be need-based and all vaccines are deemed non-universal, unless specified otherwise based on scientific evidence.

The mere availability of a safe and efficacious or even affordable vaccine cannot be a good enough justification for its widespread use.

Vaccines are not consumer goods and should not be given or taken, unless their necessity is proven based on the scientific principles of public health, according to the draft report  prepared by a institutes associated with vaccines under the aegis of the Indian Council for Medical Research.

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. 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.

National Pharmaceutical Pricing Authority (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.

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.

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 is vested with the powers for implementing provisions of DPCO.

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.

All formulations containing these bulk drugs either in a single or combination form fall under the price control category.

The price is fixed through 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 give a free reign for those drug which do not come under price-control, allowing them to increase the price by up to 10% annually.

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