New Art and Culture module by Civilsdaily

Haven’t started art and culture? Having difficulty understanding it? Click here to see the new module released by Civilsdaily.

In 2015, The Supreme Court’s described India’s drug pricing policy as irrational and unreasonable. There are many issues with drug pricing of essential medicines. To some extent, there is a debate over control on prices of essential medicines vs. industry interest.

 


 

Let’s take some back2basic concepts related to the issue

What is Drug Price Control?

Basically, it is a mechanism to regulate the prices of drugs, especially of essential medicines. The Centre issued Drugs (Price Control) Order, 2013 to regulate the prices of drugs. It initially brought under price control 652 medicines or formulations based on 348 bulk drugs listed under the National List of Essential Medicines (NLEM).

Drugs (Price Control) Order, 2013

The Drug Price Control Order, 2013 expanded the scope of regulation to 60% of the $22-billion Indian pharmaceutical market. The new DPCO, which replaced the 1995 version ( 1995 version covered 74 bulk drugs and their formulations) increased the span of controls more than threefold.

Under the existing DPCO, price ceilings for 348 NLEM drugs are set using the ‘market-based’ mechanism. While price increases of NLEM drugs are restricted to be in line with or below the wholesale price index, the non-NLEM products are allowed a maximum price increase of 10% in any one-year period.

National Pharmaceutical Pricing Authority

National Pharmaceutical Pricing Authority is an organization under Union govt, responsible to fix/ revise the prices of controlled bulk drugs and formulations.<Bulk Drugs are ingredient in a pharmaceutical drug that is biologically active and it is also the central ingredient>

It also enforce prices and availability of the medicines in the country, under the Drugs (Prices Control) Order, 1995. It also monitors the prices of decontrolled drugs in order to keep them at reasonable levels.

What are Essential Medicines?

Essential medicines are those that satisfy the priority health care needs of the country’s population. They are generally based on the country’s disease burden, priority health concerns, affordability concerns etc.

What is India’s Policy on Essential Medicines?

In India, National List of Essential Medicines decides the essential medicines. It is a dynamic list and is reviewed every 3 years to include or exclude drugs as relevant to the newest medical innovations and aligned to market competition.

How are the prices of essential medicines decided?

The ceiling price of essential medicines has been fixed based on the weighted average of the prices (MRP) of all brands of that drug that have a market share of at least 1%. If any medicine is priced lower than the ceiling fixed by the regulator, then companies selling such drugs should maintain the existing or lower retail price.

What are the demands of Industry?

Industry is seeking a 5-year exemption from drug price control as these ‘ad hoc’ measures will hinder the growth of the pharma sector. The exemption will incentivise investments in the sector, because industry is trying to invest in expansions, scale up and creating global scale.

Future

There is a need to overhaul India’s intellectual property rights regime. The soon-to-be-announced National Intellectual Property Rights Policy will, hopefully, have a positive impact here.

Published with inputs from Pushpendra

Any doubts?


  1. Profile photo of neha mittal neha mittal

    How does removing custom duty makes drugs costly? Instead It should lower the price.

    1. Profile photo of Dr V Dr V

      customs duty exemption is removed not duty

  2. Profile photo of Ramesh Ware Ramesh Ware

    Hindi medium walo ke liye aapka kaam sanjivani dawa ki tarah h …..
    CD Explain section bhi agar hindi me uplabbh kara pate to bahut meharbani hoti…
    Thank you

Delhi HC sets aside Centre’s decision to ban 344 fixed dose combination drugs

  1. Delhi High Court on Thursday set aside the Union government’s decision to ban 344 fixed-dose combination (FDC) drugs, including well known names like Corex, a cough syrup, Vicks Action 500 and D’Cold
  2. The government had banned the drugs on the grounds that they involve “risk” to humans and safer alternatives were available
  3. It’s not over yet: Before this judgment, the government had moved a petition at the Supreme Court to transfer all FDC-related matters being heard in the country so that they could be clubbed and heard afresh

Back2basics:

What is a Fixed Dose combination?

  1. An FDC is one that contains two or more drugs combined in a fixed ratio of doses and available in a single dosage form.
  2. FDCs are desirable here for their effectiveness in treating many symptoms of illness at a lower cost than two or more separate medicines.

Note4students:

Wait and watch as this debate enfolds. The counter argument by companies was that their brands had been in the market for decades, with some even producing no objection certificates (NOCs) granted by the central drug regulator for their combinations. If NOCs etc. are not being honoured by govt. would this not go against the private-public trust?

Pricing norms outdated, says NPPA chief

  1. NPPA: The Drug Price Control Order (DPCO) is outdated and has to be amended
  2. Why? Amendment will help facilitate the National Pharmaceutical Pricing Authority (NPPA) look into subjects like biosimilars and medical devices like stents
  3. Currently, NPPA doesn’t have market data for 350 medicines that come under price control

Learn about National Pharmaceutical Pricing Authority

  1. A regulatory agency of the Government of India formed in 1997
  2. Functions: To fix/ revise the prices of controlled bulk drugs and formulations
  3. To enforce prices and availability of the medicines in the country, under the Drugs (Prices Control) Order, 1995
  4. Recovering amounts overcharged by manufacturers for the controlled drugs from the consumers
  5. Monitor the prices of decontrolled drugs in order to keep them at reasonable levels

Drug price revision by NPPA

  1. News: The National Pharmaceutical Pricing Authority (NPPA) has revised the prices of 22 scheduled drugs for treating malaria, HIV, asthma, breast cancer, among others
  2. Background: NPPA had fixed the ceiling price for 123 medicines in July; and overall, since April of this year, it has put fresh ceiling prices for a total 316 drugs
  3. Stents: NPPA has now taken up the task of working out the prices of stents as well which are now officially considered drugs and come under the ambit of NPPA

What are bulk drugs?

  1. Bulk drugs are also known as active pharmaceutical ingredient (API)
  2. These are the ingredients in a drug that give it its therapeutic effect
  3. India imports almost 90% of its bulk drugs from China
  4. Common imported bulk drugs include painkillers such as paracetamol and aspirin, and antacid ranitidine – known by its trade name of Zantac

Policy on bulk drugs soon

  1. Department of Pharmaceuticals is working on a policy for bulk drugs
  2. The department has taken into considerations all recommendations of V M Katoch committee
  3. It was constituted in 2013 to study the whole issue of active pharmaceutical ingredients of critical importance

Govt to develop 6 bulk drugs, medical devices parks- II

  1. The drug parks will be established on the public private partnership mode
  2. Govt is also considering to provide one-time financial support for these bulk drug parks
  3. They will have common facilities like testing, power and effluent treatment plants
  4. Also, there will be common utilities and services such as storage, testing laboratories, IPR management, designing and guest house/accommodation, maintained by a separate special purpose vehicle

Govt to develop 6 bulk drugs, medical devices parks- I

  1. Govt of India has decided to establish three bulk drugs and three medical devices parks, which will entail a combined investment of Rs. 60,000 crore
  2. Aim: To reduce import
  3. Estimates: Once these parks become operational, they can bring down the cost of production of devices and bulk drugs by at least 30%
  4. In the long-run, this will help the general public also
  5. Need: As much as 80% of our total requirement of bulk drugs and 65% of total demand of medical devices is met through imports

Drug makers body says govt’s ban ‘arbitrary and unfair’

  1. Context: Govt.’s decision to ban 344 fixed dose combination medicines, including few cough syrups
  2. News: Indian drug manufacturers’ association said that there was no proper discussion with the industry before the ban
  3. Criticism: The amount of time, money and environmental impact in destroying these procedures will be huge

As customs duty exemption goes, 76 life-saving drugs to get costlier

  1. The Finance Ministry has withdrawn exemption of 76 medicines from customs duties
  2. Why – To boost domestic competition among Indian drug-makers
  3. Impact – It could inflate the cost of essential life-saving imported drugs
  4. The list includes 10 HIV drugs and at least 4 cancer drugs, but haemophilia patients are likely to be the most affected by the decision
  5. The withdrawal of exemption for anti-cancer and HIV medicines will not affect patients as generic versions of these drugs are made in India

Did you know about Essential medicines?

  1. Essential medicines are those that satisfy the priority health care needs of the country’s population.
  2. They are generally based on the country’s disease burden, priority health concerns, affordability concerns etc.
  3. In India, NLEM (formed in 2011) decides the essential medicines.
  4. It is a dynamic list and is reviewed every 3 years to include or exclude drugs as relevant to the newest medical innovations and aligned to market competition.

Government brings 376 drugs under new list of essential medicines

This move will ensure their availability across the country at affordable prices.

  1. The Union Government has added 106 drugs including that of HIV/AIDS, Cancer and Hepatitis C to National List of Essential Medicines (NLEM).
  2. In this regard, Union Ministry of Health and Family Welfare’s core committee has revised the NLEM.
  3. The committee was headed by V.M. Katoch, former secretary of Department of Health Research.
  4. The revision includes addition of 106 essential medicines and deletion of 70 medicines.

What is drug price control?

  1. The Centre issued Drugs (Price Control) Order, 2013 to regulate the prices of drugs.
  2. It initially brought under price control 652 medicines or formulations based on 348 bulk drugs listed under the National List of Essential Medicines.
  3. The ceiling price of essential medicines has been fixed based on the weighted average of the prices (MRP) of all brands of that drug that have a market share of at least 1%.
  4. If any medicine is priced lower than the ceiling fixed by the regulator, then companies selling such drugs should maintain the existing or lower retail price.

Govt. forms committee to review drug pricing policy

The committee will look into the pricing of medicines, and specifically in the market based pricing formula.

  1. Inter-ministerial committee to review the Drug Price Control Order (DPCO) 2013,
  2. Following Supreme Court verdict that termed drug pricing policy as irrational and unreasonable.
  3. The committee look into the pricing of medicines, and specifically in the market based pricing formula which is being used at present under DPCO 2013.
  4. The NGO had in a petition said, Market Based Pricing (MBP) was never used for any price regulatory purposes and this making medicines costlier.
  5. As stipulated under DPCO 2013, drug price regulator NPPA fixes the ceiling price of essential medicines of schedule-I.

Pharma Jan Samadhan: an online portal by Min. of Chem & Fertilizers

  1. Web enabled system for redressal of consumers’ grievances relating to pricing and availability of medicines.
  2. Created by National Pharmaceutical Pricing Authority (NPPA).
  3. Will check the menace of – overpriced medicines|shortage of medicines | sale of medicine without approval of NPPA.
  4. NPPA will initiate action on any complaint within 48 hrs of its receipt.
PIB


:( We are working on most probable questions. Do check back this section.







Highest Rated App. Over 3 lakh users. Click to Download!!!