National List of Essential Medicines (NLEM) is a list of medicines Under the provisions of DPCO , prices of the drugs in NLEM. Drug Price Control Order & case study of costing two pharmaceutical formulation. DPCO The government has notified the DPCO under NLEM (National List of Essential Medicines) Formulations with. in ceiling prices of drugs under NLEM under Para 19 of the DPCO bring more medical devices under the National List of Essential Medicines ( NLEM).

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The WAP oof has, in effect, hnder relation with the cost of raw material, let alone the cost of other inputs. Write detailed comment, relevant to the topic. To know about the strategy or to download or read the booklet, click here.

The impact of this action may be that the manufacturing company may stop the production of these drugs and ultimately the availability of these good and effective medicines will be less in the market which can cause a lot of problem as the replacement of these drugs is very costly. Although this notification of NPPA will give some relief to patients in the chronic disease sector in the present context, it should be expanded and rationalized.

The shift in focus from market share to whether medicines are essential is to be welcomed. NLEM consists of items like insulin, ibuprofen, sulphamethoxazole, rifampicin, streptomycin, Ranitidine, etc which are bulk drugs and at the same time medicines or formulations as well when these are manufactured as single ingredient oist.

The draft policy gives a formula to discourage non-standard dosages. Following this, a new pharmaceutical pricing policy was introduced in the year which dlco liberalized the span of control over pricing. We also note that the notifications have not included fixed dose combinations in the cardiovascular and diabetes therapeutic categories whereas the sales of many combinations exceed those of the single molecule medicines.

The turnover limit for purposes of price control was raised from Rs. Prices of medicines can be brought down to one half, even to one-fourth immediately, if the government takes appropriate measures to stop reckless profiteering and waste that are prevalent in the manufacture and sale of medicines.

List of 348 Drugs that may come under Drug Price Control Order ( DPCO ) 2012

IMS Health, which began tracking and reporting on branded generics indefines rdugs category as including prescription “products that are either novel dosage forms of off-patent products produced by a manufacturer that is not the originator of the molecule, or a molecule copy of an off-patent product with a trade name.

Advertisements Leave a lish. All these point to the complexities involved in regulation of pharma pricing. Limiting all price regulation only to a list of medicines and specified dosages and strengths in the DPCO goes against the policy objective of making medicines affordable to the public.


The ceiling price calculated and notified by the Government is applicable to imported formulations also. This order was challenged by the Government in the Supreme Court which vacated the stay vide its order dated Lits DPCOs, particularly during unrer earlier DPCOs when the bulk drugs prices were fixed alongside their related formulations, some companies either stopped producing the particular formulation or started producing only for export destinations.

Making India sufficiently self-reliant in end to end indigenous drug manufacturing; d. To download the entire issue of Health Action, September issue, click here. Moreover, doctors hardly prescribe medicines by generic names, but by brand. Operational Guidelines on Free drug service Initiative. It would have made sense to have the ceiling price of a medicine formulation tied directly to the related bulk medicine price increase during the year.

Media, Telecoms, IT, Entertainment. This product comes under drug price control as per the government notification. While it may undre many more years to change the govt …….

The various drug policies adopted from time to time have tried to cope up with the challenge of striking a balance between the at times varying requirements of enabling industry to grow and at the same time ensuring affordable and reasonably priced medicines to the consumers, particularly the poorer masses.

We are surprised at the misinformation being spread by the Pharmaceutical Industry in this regard, and its efforts to prevent relief to the consumer by filing petitions in the high courts in Mumbai and Delhi. The DPCO replaced the DPCO which included only 74 bulk drugs within its ambit to regulate their dlco and the pricing of such drugs were fixed on the basis of manufacturing costs declared by the drug manufacturers.

Maithili Bandarkar 03 Apr Non – ceiling prices fixed by NPPA under para 8 12 and 4 and para 11 of DPCO, are specific to a particular pack size of scheduled formulation of a particular company. unxer

The basis of drugs to be considered was the NLEM,being the latest list at that time. This year alone, there will be over 40 million deaths in developing countries, one-third among children under age five. The arguments for totally relying on market-based pricing MBP of formulations apparently do not recognise the fact that there exists a wide range of prices in the market of the same formulation and that prescribers, and therefore patients, tend to place more value on the costlier brands of the same formulation.

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Essential Drugs | All India Drug Action Network (AIDAN)

NPPA should come out with similar action to cover all dosage forms and fixed dose combinations containing one or more medicines under NELM, and as well as bring other essential and life saving medicines under price control immediately. Energy and Natural Resources. Pronab Sen to look into the issue of price control, options other than price control, and other issues and to make recommendations for making available life saving drugs at reasonable prices. There is no specific mechanism available in the DPCO, to check the difference between the actual cost of production and the retail price of medicines.


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Recent order of Government for withdrawal of the internal guidelines formulated by the NPPA under para 19 of DPCOWitnessing such outrageous response from the industry, the Government realized that the implementation of such internal guidelines formulated by the NPPA in pursuance of the powers conferred to it under Paragraph 19 of DPCO, is extremely harsh pressure on the Pharmaceutical Industry and its players as it adversely disturbed and get in the way of the smooth operation of the industry.

This is a good move by the Government of India. Recently on 22 Septemberas per directions received from the Government in the Department of Pharmaceuticals under the Ministry of Chemicals and Fertilizers vide letter no.

The Drug Policy ofas implemented through the Drugs Prices Control Order,was introduced in the context of the liberalization of economy and the abolishment of industrial licensing, as well as allowing of foreign investment in the country, including in the drug industry. Such medicines will have a maximum retail price MRP equal to or lower than the ceiling price plus local taxes as applicable as notified by the Government for respective medicines. Please somebody explain ceiling price of Silver Sulphadiazine 15gm tube.

The monthly market turnover reports of IMS Health a US based company that provides information, services and technology for the healthcare industry and the information furnished by individual manufacturers are utilized for the purpose of monitoring prices of non-scheduled formulations. Having perused the two Office Memorandums placed by the learned senior counsel for Union of India and Department of Chemicals and Fertilizers, we deem it proper to direct the Secretaries of two Ministries to file their affidavits within four weeks indicating therein as to within what time the revised list of National List of Essential Medicines NLEM will be added in Schedule-I of the Drugs Price Control order, In this proposal life essential and life saving drugs prices forced to reduced as minimum as possible.