Tag Archives: Health

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 The notifications for the 108 formulations (two were subsequently withdrawn) of these selected medicines are in addition to the notifications for essential medicines declared under the DPCO 2013.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

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

“Mashelkar Report ll underestimates India’s right to define patentability standards”

Mashelkar Report II underestimates India’s right to define patentability standards” – Professor Brook K. Baker, Northeastern U. School of Law, Program on Human Rights and the Global Economy; Health GAP (Global Access Project), October 9, 2009

For the second time, the Mashelkar Committee has misinterpreted India’s flexibility under international law to limit patents of pharmaceutical products to new chemical entities, or new medical entity involving one or more inventive steps………

The Committee has made three fundamental mistakes:

(1) it still incorrectly analyzes India’s flexibilities under TRIPS to define pro-health standards of patentability,

(2) it fails to analyze key TRIPS-minimum patent standards, especially novelty and inventive step, and

(3) it incorrectly concludes that a NCE-only standard of patentability for pharmaceutical products would constitute discrimination against a field of technology and in doing so misinterprets and misapplies the expert analysis of Professor Carlos Correa, an internationally renowned IP specialist.

To read the complete Mashelkar II Report Critique, please visit: http://www.healthgap.org/analysis-of-mashelkar-report.htm

MAKING MEDICINES AFFORDABLE – Reaching the Unreached

MAKING MEDICINES AFFORDABLE - Reaching the Unreached

MAKING MEDICINES AFFORDABLE - Reaching the Unreached

LOW COST MEDICINES INITIATIVE – CHITTORGARH
DISTRICT LEVEL INTERVENTIONS – THE MODEL

“We knew that the actual cost of most of the drugs is very low. But, these were not available to patients at low rates because of three obstacles:…………….. So, the district administration adopted the following strategy to provide low cost medicines to the patients.”

These are some excerpts from the booklet “MAKING MEDICINES AFFORDABLE – Reaching the Unreached” – documented by Dr. Samit Sharma, Collector and District Magistrate, Chittorgarh. To know about the strategy or to download or read the booklet, click here

To know more about the low cost medicines initiative in Chittorgarh, click here

To see the comparisons between printed M.R.P. of medicines and prices at CHITTORGARH SAHAKARI UPBHOKTA THOK BHANDAR LTD., CHITTORGARH, click here

Open letter to WHO on Pneumococcal Vaccine

February 16, 2009

To,
Dr. Margaret Chan,
Director-General of WHO,
Geneva

Dear Dr. Chan,

Greetings from All India Drug Action Network – AIDAN !

All India Drug Action Network is an all India network of organization and concerned individuals who have been advocating for more than twenty five years on issues related to the access, prices, safety , quality and rationality of medicines in India and their appropriate use by both health professionals and consumers.  Our activities have included publications, campaigns, media briefings, meetings, and even public interest litigations. It is due to the efforts of AIDAN, that many unsafe and irrational medicines have been removed from the Indian market.

We were delighted to read your comments in the ‘The Lancet’ dated 15th January 2009, titled “Primary health care as a route to health security”. We quote here a statements you have made about Primary health care in the Lancet “This approach to health is people-centred, with prevention considered as important as cure. As part of this preventive approach, primary health care tackles the root causes of ill health, including in non-health sectors, and offers an upstream attack on threats to health. As the report1 noted, better use of existing interventions could prevent 70% of the global disease burden.”

But unfortunately this perspective is not reflected in some of your actions. For example you have not responded positively to the request one of our AIDAN members sent you in the case of pneumococcal vaccine, based on the Primary Health Care perspective. The Drug Action Forum – Karnataka (DAF-K) which is a constituent organization of AIDAN had communicated to you the concern in a letter dated 2nd September 2008, regarding the “revelation that for every four children in whom pneumonia is prevented, two children develop asthma because of the vaccine”. This is because the pneumococcal vaccine in question is the one that is being promoted by WHO globally and in India. A copy of the letter sent by DAF-K is attached with this letter for your reference.

Your personal assistant Alison Porri, has acknowledged having received DAF-K’s letter on 4th September 2008, with a promise to “to acknowledge receipt of this e-mail”. And that “Your letter will be carefully reviewed and a response will be forthcoming”. But unfortunately DAF-K has not heard from your office. The issue was discussed at the 14th November 2008 of AIDAN and members expressed grave concern over the issue. Your eerie silence is creating a doubt in the mind of the health conscious members of AIDAN whether you mean what you wrote in The Lancet article mentioned above. (AIDAN is the larger national body, whereas DAF-K is a state level organisation and member of AIDAN along with several other nation wide constituents).

We the under signed express grave concerns about this whole issue.  If by 27th February 2009 we do not hear from you then many of us will walk into the WHO office at Delhi and demand for the same information.

Hoping to hear from you soon,

Yours truly
Dr Gopal Dabade, (drdabade@gmail.com)
Dr Mira Shiva, (mirashiva@gmail.com)
Mr. Srinivasan S, LOCOST (sahajbrc@youtele.com)
Dr Anurag Bhargava (anuragb17@gmail.com)
Dr C Sathyamala (csathyamala@gmail.com)
Dr Jacob Puliyel (puliyel@gmail.com)
Dr. Anant Phadke (anant.phadke@gmail.com)

Profit making vaccine companies and WHO -Open letter

OPEN LETTER TO WORLD HEALTH ORGANISATION (WHO) DIRECTOR-GENERAL (DG) FROM DAF-K*

2nd September 2008

From,
Drug Action Forum – Karnataka (DAF-K)*,
57, Tejaswinagar, Dharwad 580002, Karnataka, India.
Fax & telephone +91 (0)836 2461722, Mobile +91 (0)9448862270
Email; – drugactionforumkarnataka@gmail.com, Web; – http://www.daf-k.cjb.net

To,
Director-General,
World Health Organization
Avenue Appia 20
1211 Geneva 27, Switzerland,
Fax number +41 22 7913131
Dear Ma’am,

Drug Action Forum – Karnataka (DAF-K), from India would like to bring to your notice facts which are really alarming and indicate the strong influence that profit making vaccine companies have on the esteemed WHO. These unhealthy nexus between WHO and the vaccine industry, we fear will have far reaching negative influence on the lives of millions of children all over the world. With these major concerns we lay down before you facts which are as follows:

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