Tag Archives: India

Civil society letter on NPPA’s action on price control

Shri Ananth Kumar
Hon’ble Minister of Chemicals and Fertilizers
Udyog Bhavan
New Delhi 11001
 
20 August 2014
 
Dear Ananthji,

 

The National Pharmaceuticals Pricing Authority (NPPA), on July 10, 2014, released a new set of price notifications for 50 cardiovascular and diabetes medicines under paragraph 19 of the Drug Prices Control Order (DPCO), 2013. The notifications for the 108 formulations (two were subsequently withdrawn) of these selected medicines are in addition to the notifications for essential medicines declared under the DPCO 2013. We note that the earlier notifications for essential medicines excluded several dosage forms and strengths because they did not feature in the National List of Essential Medicines (NLEM), 2011. Thus the recent notifications were necessary to cover more of the strengths of medicines than that are listed on the NLEM. In addition, the notifications also covered medicines in the cardiovascular and diabetes therapeutic categories that are not included in the NLEM.

We the undersigned civil society organizations welcome the initiative of the NPPA to cap the prices of formulations involving essential and lifesaving medicines that fall outside the NLEM as a first step towards the institution of a robust, pro-public health policy of drug price control. This is an action that truly interprets the spirit of the Drug Prices Control Order, and its underlying legislation the Essential Commodities Act, 1955. In the past, despite its attention being drawn to the profiteering in medicines not listed in the DPCO, the government had looked the other way.

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. Industry has challenged the legality of fixing the prices of the 50 medicines under Paragraph 19 of the DPCO 2013 when in fact the Government has in successive drug price control orders always retained the power to intervene in prices in the public interest in the light of evidence of overpricing.

Limiting all price regulation only to a list of 348 medicines and specified dosages and strengths in the DPCO 2013 goes against the policy objective of making medicines affordable to the public. The National List of Essential Medicines, a list of 348 rational and cost-effective medicines, is not the basis for production, promotion and prescription in India. In reality the most frequently prescribed and consumed medicines are not listed in the NLEM.

Industry has claimed that this will cause an annual loss of revenues of over Rs.600 crores. NPPA’s action on the market will however be marginal, and nowhere near the doomsday predictions of the industry. It will affect only those brands that were selling at very high prices. We have analysed the impact of the notifications and found that the retail market of Rs.77,526 crores (Moving Annual Total, June 2014) would experience a loss of  Rs. 350 crores (AIOCD-AWACS, PharmaTrac Data, 2014).  This represents a loss of approximately only 2% (Rs. 112 crore) in the anti-diabetic therapy segment and 2.5% (Rs. 238 crore) in the cardiac therapy segment. This in a way establishes the excess profits of the industry in those particular formulations by overcharging the patients.

Also the market based price fixation being followed by the NPPA, a departure from the long used cost-based price control mechanism, is irrational and means that the ceiling prices are still very high. Many medicines are sold by reputed companies much below the NPPA ceiling price. The ceiling price of atorvastatin 40mg is Rs. 22.02 per tablet while Biochem Pharmaceutical is selling the same at a much lower price of Rs. 14.94 per tablet. The ceiling price of glimepiride 3mg is Rs. 10 per tablet, while Ipca Laboratories is able to sell it for Rs. 6.90 per tablet. As per our calculations only a little over one fourth of packs selling on the market will need to revise their prices downwards because they were originally priced higher than the notified price. This is evidence that there is a scope for significant reduction in NPPA ceiling prices, without affecting the reasonable profits of the industry.

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.

We also raise the argument that fixing of ceiling prices of all the other dosage forms of all medicines under NLEM cannot be neglected. Here again the same phenomenon of overcharging remains. 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.

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. We request the Government and NPPA to strongly defend its stand and also consider the actions suggested by us to promote public health.

Signed,

All India Drug Action Network (AIDAN)
Jan Swasthya Abhiyan
Low Cost Standard Therapeutics (LOCOST)
Medico Friends Circle
Third World Network- India
All India Peoples Science Network (AIPSN)
National Working Group on Patent Laws

 
Copy to:
Hon’ble Shri Narendra Modi, Prime Minister of India
Hon’ble Shri Dr. Harsh Vardhan, Minister of Health and Family Welfare
Mr. Nripendra Misra, Principal Secretary, Prime Minister’s Office
Mr. Lov Verma, Secretary, Department of Health & Family Welfare, Ministry of Health & Family Welfare
Ms. Aradhana Johri, Secretary, Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers
Mr. Injeti Srinivas, Chairman, National Pharmaceutical Pricing Authority, Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers

 
 
 
For further information, contact:
 

LOCOST
1st Floor, Premanand Sahitya Bhavan
Dandia Bazaar
Vadodara, Gujarat – 390001
Ph: 9998771064
Email: chinusrinivasan.x@gmail.com

Jan Swasthya Abhiyan
National Secretariat
c/o Delhi Science Forum
D-158, Lower Ground Floor
Saket, New Delhi 110017
Ph: (011) 26524323, 26862716
Email: jsasect.delhi@gmail.com

 
 
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Generic Dava – Isse Behtar Kuchch Nahi…

DainikBhaskar

Why your medical bill is not coming down?

The price caps imposed by the Indian government on 348 drugs in 2013 have created only an illusion of control, keeping many medicines for conditions ranging from asthma to diabetes and heart disease beyond price regulations… reports The Telegraph. Read more

Moneylife reports that while market-based pricing can potentially reduce the price for two-thirds of essential medicines, there are far too many loopholes. Read more

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Infographic Source: The Telegraph

Fresh plea filed against drug price control in SC by AIDAN & others

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Mumbai: Non-government organisations (NGOs) led by AIDAN (All India Drug Action Network) have filed a fresh application in the Supreme Court as part of their decade-long petition that had forced the government to bring all 348 essential drugs under price control. AIDAN, LOCOST, Medico Friend Circle and Jan Swasthya Sahyog together have filed a fresh intervention application in the Supreme Court, opposing the National Pharmaceutical Pricing Policy (NPPP 2012) and marketbased pricing mechanism to determine ceiling prices of drugs which are being brought under price control.

According to the fresh intervention application, the simple average formula to determine the ceiling prices (of drugs) actually increases their prices and… read more

Source: Times of India

Fresh plea filed against drug price control in SC

Open letter to DG, WHO – Pentavalent vaccine related deaths in India

To

Dr. Margaret Chan The Director General, World Health Organisation, Geneva

Dear Dr Margaret Chan,

All India Drug Action Network (AIDAN) is a network of not-for-profit civil society organisations that has been campaigning and working for rational use of medicines, largely in the Indian context. We have written to you in the past. We would like to bring your attention to the deaths Pentavalent (DPT + Hib + Hepatitis B) vaccine related deaths in India.

According to the Brighton classification of ‘adverse events following immunization’ (AEFI), re-challenge and recurrence of symptoms in the individual is needed for classification of AEFI as ‘certainly related to vaccine’. Such re-challenge is impossible if in the first instance, AEFI results in death. In the absence of proof from a re-challenge experiment, deaths caused by vaccines can only be classified as ‘probably related to vaccine or possibly related’ to the immunization.

As you would know, there have been several Pentavalent vaccine related deaths in Sri Lanka, Bhutan and Pakistan. Using the WHO approved classification of AEFI many of these deaths are ‘probably related to the immunization’ because no alternate cause for the adverse events has been found. However an expert panel looking at the deaths in Sri Lanka deleted ‘probably related’ and ‘possibly related’ from the classification of Brighton for purposes of their evaluation report, and then certified that the vaccines were ‘unlikely to be due to the vaccines’. This report (Expert Panel Report 23 December 2008 Sri Lanka) is available on the World Wide Web.

One by one the WHO has delisted a number of brands of prequalified Pentavalent vaccine, but the problem has refused to go away. Pentavalent vaccine was introduced in two states in India on 14th December and 17th December 2011, to evaluate the safety of the vaccine in India. According to an affidavit filed in the Kerala High Court by the Government of Kerala India, there have been four deaths in less than two months since it was introduced in the public health system. For your information the full text of the submission by Kerala government can be accessed here.

The reactions in India suggest that the cause of the problem is unrelated to the brand or manufacturer or lot of the vaccine. It appears to be a form of ‘hypersensitivity reaction’ as described in the post mortem report on one of the children in Kerala. The vaccine can be administered to many patients without problems and there is no available method at present to predict which infant will react adversely. The US FDA has pointed out that vaccines are aimed mostly at healthy individuals for prevention of diseases to which an individual may never be exposed. Unlike conventional drug treatments meant for the management of existing disease, in prophylaxis with vaccines, safety is of paramount importance. Vaccines that frequently and unpredictably cause death of healthy children cannot be recommended.

Pentavalent vaccine is at present recommended by WHO and its introduction is supported by GAVI funds. Given these circumstances the WHO needs to re-evaluate the recommendations. We propose to copy this letter to countries supporting the GAVI initiative so that they may be able to initiate action in a responsible manner.

Looking forward to your early action in the regard.

1. Dr Jacob Puliyel, Drug Action Forum – Karnataka (DAF-K), New Delhi

2. Dr Mira Shiva, Medico Friend Circle, New Delhi

3. Dr Gopal Dabade, DAF-K, Dharwad

4. Mr Srinivasan. S, LOCOST, Vadodara

5. Mr Naveen Thomas, Headstreams, Bangalore

6. Mr Prasanna Saligram, AID India, Bangalore

7. Dr Anurag Bhargava, JSS, Chattisagarh

ALSO READ: Vaccine woes continue, Down To Earth, March 12, 2012

Global Week of Action: India- EU Free Trade Agreement (FTA)

GLOBAL WEEK OF ACTION: India- EU Free Trade Agreement (FTA)
6-10 February 2012

In 2001, India’s generics brought prices down from $15000 per person per year to $350 for first line AIDS medicines.

80% of people living with HIV in developing countries are on Indian generic ARVs

Over 90% of paediatric AIDS medicines are supplied by Indian generics.

BUT ALL THIS COULD CHANGE IF INDIA DOES NOT SAY NO TO INTELLECTUAL PROPERTY (IP) IN THE INDIA-EU FTA

In January 2012, another round of negotiations on intellectual property was held between Indian and EU negotiators as part of the India-EU Free Trade Agreement (FTA) talks. News reports in India quote the EU Ambassador as stating that discussions on Pharmaceuticals have progressed significantly.

On the 10th of February 2012, at the India-EU Summit to be held in Delhi, the EU & India will agree on and finalize the political framework for the FTA. Groups in India are worried – how have the IP negotiations progressed?

Are the EC and India progressing towards an agreement which includes provisions that will seriously hamper India’s ability to manufacture safe, effective and affordable generic medicines and export these to other developing countries?

WHY THE CALL FOR ACTION? 6th – 10th FEBRUARY 2012!!

Since 2007, people living with HIV in India and across the world have been resisting the pressure of the EC on India to sign an FTA with provisions on intellectual property that will endanger access to generic medicines from India. We must once more show the EC and the Indian government that our lives cannot be traded away!

This is a Call for a week of Action across the globe from 6th – 10th February 2012 on the EU-INDIA FTA.

The week of action is a run up to the EU-India Summit that will be held in Delhi on 10th February 2012.

OUR DEMANDS

REMOVE:

§  Investment Rules, as they enable foreign companies to take the Indian government to private courts over domestic health policies like measures to reduce prices of medicines.

§  Border Measures, as they will deny medicines to patients in other developing countries with custom officials seizing generic medicines in transit.

§  Injunctions, as they undermine the independence of the Indian judiciary to protect right to health of patients over the profits of drug companies.

§  Other Intellectual Property Enforcement Measures, as they put third parties like treatment providers at risk of police actions and court cases.

DON’T BRING BACK:

§  Data Exclusivity, as it delays the registration of generic medicines and will not permit the placing of affordable versions of pediatric doses and combinations of “off-patent” medicines on the market. IT’S NOT REQUIRED UNDER THE TRIPS AGREEMENT!

§  Patent Term Extension, as it will extend patent life beyond 20 years.

The EC states that these two provisions are off the table. It must keep its word!

PLEASE JOIN US -YOUR FRIENDS- IN INDIA!

In the coming days, groups from around the world and in India will demonstrate against the EU-India FTA. We ask you to join us in sending a clear message to the European Commission: our lives cannot be traded away.

1.   Organise your own rally: You can organize rallies or demonstrations in front of European Commission offices in your countries to voice your opposition to their aggressive negotiations on intellectual property in FTAs. Don’t forget that the EU is also negotiating FTAs with many other developing countries and making the same demands.

2.    Raise awareness/media action: Even though you might not be able to support our rally financially or physically you can help us by spreading the word about our concerns. Write an editorial in your local paper. Hold a press conference. Issue a press release or press statement.

3.    Write to the Indian Government: You can also write to the Indian Government asking it to stay strong and not give in to the demands of the European Commission. India, as the pharmacy of the developing world, has an obligation to its citizens as well as patients across the world. Please try and meet the Indian ambassadors in your countries and convey to them how important it is that India reject ALL the demands of the EU. Millions of lives depend on this.

4.    Write to your own government: Public health programmes around the world depend on generic medicines from India. Ask your government to tell the EU and the Indian government to keep IP out of the FTA negotiations.

5.    Share your actions: PLEASE send us photos, articles, videos of all your actions immediately and FOLLOW the actions of other groups on Facebook or at Don’t Trade Away our Lives

6.    Donate: In order to organize these protests, we rely on funding. Any financial support is welcome. No amount is too small – or too big! If you know organizations, which are interested in funding, if you want donate to our protest, please contact us.

We plan to meet the aggressiveness of the European Commission with our peaceful protests. There is too much at stake. Join us NOW!

In Solidarity

Delhi Network of Positive People & Lawyers Collective HIV/AIDS Unit

++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++

For information on the India-EU FTA see:

Open Letter to Prime Minister of India Regarding Selection of Persons with Conflict of Interest as Board Members of Medical Council of India (MCI)

Date 7th June 2011

To

Dr. Manmohan Singh,
The Prime Minister of India, New Delhi,
Fax number-11-23019545 / 91-11-23016857

Dear Prime Minister,

We, a concerned group of citizens and civil society members, express grave concerns over recent media report[i] regarding the selection of persons with multiple conflicts of interest as board-members of the Medical Council of India (MCI).

MCI is an apex body that regulates not just medical education in the country, but also acts as a watchdog to ensure that the Indian medical fraternity adheres to the highest level of ethics. However, it has not been playing its expected role. Considering the recent turn of events, we believe that MCI would be in a similar situation as it was when Dr. Ketan Desai was the president of MCI. Corrupt practices had sullied the image of the MCI[ii] and affected the credibility of the entire Indian medical fraternity. We fear that unless tough measures are taken, the same situation will recur. People with unblemished backgrounds need to be involved in running the MCI otherwise the important role of oversight of medical ethics in India will remain unfulfilled.

As you are aware, at the time that Dr. Ketan Desai was arrested, the Central government promulgated the Indian Medical Council (Amendment) Ordinance 2010 suspending the MCI and giving itself the power to re-constitute the Council for one year. The Central Government then appointed a group of esteemed and well respected medical professionals to oversee the reform of medical education and the oversight of the medical community. During their year’s tenure, one of the foremost tasks of this re-constituted Council related to the revamping of medical education in the country. This work resulted in the key recommendation of the centralization of Medical Entrance Tests. In May, this year the time period under the 2010 Ordinance was to expire. However, the Central Government has promulgated another Ordinance extending the time of the re-constituted Council by another year. It has come as a surprise to the health community that along with the one year extension the government has seen fit not to re-appoint a single member of the original re-constituted Council and has made new appointments.

The manner in which the previous Council has been disbanded with and the appointment of the new members has caused considerable disquiet among the health community. There is a danger that the government’s actions will be seen as arbitrary and questions in the media about the potential conflicts of interest of the new Council members are already circulating.

India has a very large private health sector (perhaps the largest in the world) which has contributed positively in some ways, but has also exacerbated the problems of unethical practices like recommending unnecessary medical investigations and over-prescribing medicines. Today it accounts for 82% of outpatient visits, 58% of inpatient expenditure, and 40% of births in institutions[iii]. Private sector interest in medical education has also grown considerably and there is now significant overlap between doctors in the private sector, private hospitals and the medical education business. This gives us an idea of the extent of the problem which needs to be addressed. These practices need to be reigned in urgently so that exploitation of the common people can be stopped. To achieve this we need people of integrity to be at the helm of MCI and definitely not the type of persons that have been reportedly selected.

As the Prime Minister is also aware, the Supreme Court of India had recently given the go-ahead for the Common Medical Entrance Test as recommended by the previous Council[iv]. In a recent case involving another regulator, the Food Safety and Standards Authority of India, the Supreme Court has also made it evident that appointments by regulatory bodies cannot have conflicts of interest[v].

The MCI as the regulatory body for medical education and medical ethics cannot afford to be tainted yet again. Towards achieving the goal of transparency and accountability in the functioning of MCI, we suggest the following:-

1)      An immediate review of the manner and reasons behind the disbanding of the original re-constituted Council and the new appointments made by the Health Ministry

2)      Selection of individuals who have also worked in the field of medical education rather than selecting pure clinicians

3)      Do not appoint and short-list persons with conflicts of interest including practitioners who are primarily from the private sector, that have ethical complaints pending against them or the hospitals they supervise, have private interest in decisions of the MCI including those related to medical education such as changes in the eligibility criteria or relaxation of norms for setting up of medical colleges, etc.

4)      Create mechanisms for background checks of potential candidates and eliminate people who do not have a clean track record

5)      Ensure that the decision making process, including the selection of board members is done through a free, non-arbitrary and transparent process

We urge you to look into this matter on a priority basis as it concerns the future of an important national Council. We trust you will take immediate action in this regard.

Yours truly,

1)      Dr Mira Shiva, Co-convener, AIDAN, 9810582028, mshiva@nda.vsnl.net.in

2)      S Srinivasan, , Co-convener, AIDAN, 9998771064

3)      Anant Phadke, Medico Friend Circle, 9423531478

4)      Prasanna, Co-convener, AIDAN, 9977216619

5)      Gopal Dabade, , Co-convener, AIDAN, 9448862270

6)      Naveen Thomas, headstreams, 9342858056

7)      Prafulla, headstreams, 9611866200

8)      Leena Menghaney, ITPC India, 9811365412

9)      Kajal Bharadwaj, New Delhi,

10)  Prabir Chatterjee, Medico Friend Circle, 09433310060,

11)  Veena Shatrugna, Former Deputy Director, National Institute of Nutrition     Hyderabad 500017, 09391111291,

12)  Dr SL Pawar, Drug Action Forum – Karnataka, Ranebennur, 09449354415

13)  Manisha Gupte, Pune

14)  Padma Deosthali,CEHAT, 9892537994,

15)  Dr. Anand Philip, http://anandphilip.com,

16)  Dr S Sridhar, MFC, 9811516335,

17)  Sunil Kaul, 9435122042,

18)  Jagannath Chatterjee, Bhubaneswar.

19)  Renu Khanna. SAHAJ.

20)  Narendra Gupta, Prayas, Cell : +91.9414110328,

21)  Sarojini, SAMA, New Delhi

22)  Dhruv Mankad, NASIK 422002, Cellphone 9423178183

23)  Dr Vandana Prasad, Community pediatrician and public health worker, 9891552425,

24)  Amar Jesani, Mobile: +91- 9833073773,


References:

[i] MCI board smacks of conflict of interest, Mail Today (E-paper), 17th May 2011, http://epaper.mailtoday.in/Details.aspx?boxid=15354515&id=53362&issuedate=1752011

[iii] The private sector in India, BMJ,  http://www.bmj.com/content/331/7526/1157.full

[iv] Common test for medical courses, says Supreme Court, The Mint, 7 March 2011,

http://www.livemint.com/2011/03/07223907/Common-test-for-medical-course.html