Category Archives: Medicine

Pharma Price Control Policy: Unrealistic and Unfair

Economic & Political Weekly (EPW) August 23, 2014 Vol XlIX No 34

S Srinivasan, T Srikrishna, Malini Aisola

Despite the government’s and pharmaceutical lobby’s claims and counterclaims, the Drugs (Prices Control) Order, 2013, which covers only 18% of the total domestic market of Rs 71,246 crore, has had very little positive effect as a price control policy. This article points out that the Order leaves out much that should have been included, while including much that should have been left out. Its provisions have made the playing field more uneven, with multiple ceiling prices, which is very unfair to consumers already dealing with an irrationally priced market

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Compulsory Licensing in India: A historic move to make drugs affordable

The government’s decision to grant a compulsory licence for the manufacture of an important anti-cancer drug should be the first step towards making available essential drugs at little or no direct cost.

Read more: The Hindu, March 14, 2012

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

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

Ensuring affordability, accessibility and safety of medicines through urgent action

Health Action

Health Action

Health Action (HA) has published articles relating to essential medicines, generic medicines, drug price control and other drug related issues in its September 2009 issue. Some of the relevant articles have been uploaded here (with permission from HA).

Dubious Rather Than Spurious Drugs – India’s Real Drug Problem
Dr Anurag Bhargava M D

Access to medicines implies access to medicines of proven efficacy, safety and acceptable quality, prescribed in a rational manner. Governments have a responsibility of ensuring availability and affordability of such medicines. Yet the situation in India with all these issues related to medicines is marked by paradoxes. In spite of having one of the largest pharmaceutical industries supplying low-cost essential medicines globally, India has the largest number of people in the world without access to essential medicines, …………

People’s Initiative for Generic Medicines
Dr. Anant Phadke

In India, medicines are unnecessarily exorbitantly costly. 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. Since the early eighties, the All India Drug Action Network (AIDAN) has been advocating these measures, but in vain. While it may take many more years to change the govt…….

Essential Medicines: Economic constraints in access in India
Dr. Purnabrata Gun & Sushanta Roy

Essential medicines are among the most costeffective elements in modern health care and their potential health impact is remarkable. This year alone, there will be over 40 million deaths in developing countries, one-third among children under age five. Ten million deaths will be due to acute respiratory infections, diarrheal diseases, tuberculosis, and malaria. Safe, inexpensive, essential drugs can be life-saving in all these disease conditions……..

Good to be True, but True! Retail Sale of Generic Drugs at Low Prices by the Government in Chittorgarh Dt
S.Srinivasan

We all know that one of the solutions for making medicines affordable to people is to make available only essential generic drugs at lower prices, that is if your doctor prescribes them in the first instance. Procurement prices of generic drugs by Governments like that of Tamil Nadu and Delhi have revealed that prices of generics are 1.5 % to 10 % of the maximum retail price (MRP) of branded equivalents at the retail level. However, to get a retail pharmacist to stock these low-priced generics is easier said than done…..

Drug Price-Control: Problems, Principles and Prospects
Dr Chandra M Gulhati

One way or the other, prices of many sensitive goods and services are subject to some sort of price regulation either through state’s intervention or other mechanisms including competition, negotiated prices by bulk buyers, reimbursement by insurance companies just to mention a few…………

To download the entire issue of Health Action, September 2009 issue, click here

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)