Tag Archives: India

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

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

“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





“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

AIDAN Policy Brief on Drug Pricing released

AIDAN Policy Brief on Drug Pricing Released

AIDAN Policy Brief on Drug Pricing Released

The AIDAN Policy Brief on Drug Pricing was released in the Press Club of Bangalore on March 30, 2009 by Shri.H.S.Doraiswamy, freedom fighter and human rights activist. The policy brief was dedicated to the memory of Dr. Wishvas V. Rane (1930-2008), one of the founders of AIDAN and beloved senior most drug activist. It contains some of AIDAN’s major demands on drug pricing and drug policy.

S. Srinivasan and Anurag Bhargava authored the initial draft of this policy brief. S. Srinivasan works with Low Cost Standard Therapeutics (LOCOST) at Baroda . Anurag Bhargava is a physician with Jan Swasthya Sahayog (JSS) at Bilaspur . This brief had also greatly benefited from feedback of Drs. Anant Phadke and Mira Shiva. The illustrations for the policy brief was provided by Dr. Harish Zagade. In addition to the sizeable media turn out, others members of AIDAN, including Dr. Gopal Dabade, Co-convenor of AIDAN; Dr.Prakash C.Rao, DAF-K, Dr.S.L.Pawar, Ranebennur; Shreerekha, Lawyer’s Collective; Padma Priya and Naveen Thomas, headstreams were also present.

To download the policy brief on drug pricing, click here

For more materials on drug pricing, click here

Open letter to WHO on Pneumococcal Vaccine

February 16, 2009

Dr. Margaret Chan,
Director-General of WHO,

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)

NGO asks WHO not to support Wyeth’s anti-pneumonia vaccine

The Economic Times, Delhi edition dated Sep 18, 2008 (Page Number 26) carried news about Drug Action Forum of Karnataka (DAF-K) open letter to World Health Organisation (WHO) regarding the pneumococcal conjugate vaccine.

GLOBAL pharma major Wyeth’s vaccine Prevenar is caught in dispute as the Drug Action Forum of Karnataka (DAF-K), a member of All India Drug Action Network (AIDAN), has asked the World Health Organisation (WHO) to withdraw its support for the pneumococcal conjugate vaccine.

NGO asks WHO not to support Wyeth’s anti-pneumonia vaccine

In an open letter to WHO, the Karnataka-based forum said a recent study revealed that the vaccine does not reduce clinical pneumonia and is likely to cause asthma in children. “It has been found through studies that the vaccine reduces a rare type of pneumonia called radiological pneumonia and only about 4 cases are prevented for every 1,000 children immunised and what is even more dangerous is that for every four in whom pneumonia is prevented, two children develop asthma because of the vaccine,” DAF-K president Dr Gopal Dabade said. Prevenar is the only licensed…. To read more, click here

To read the open letter sent by DAF-K, click here

IMA Recommendations on Polio

A National Consultative Meeting on the Polio Eradication Initiative (and Hepatitis-B) was held on 14th May 2006 by the Indian Medical Association (IMA).  While the complete report of this meeting is available on the IMA website (www.imanational.com), we reproduce here the Recommendations on Polio.

Polio Eradication: Current Status

Gains Achieved by the programme

  • Confirmed wild polio cases down significantly.
  • Number of `infected states’ has decreased.
  • Very focal transmission now.
  • P3 almost absent.
  • Less genetic bio-diversity now.
  • Coverage during pulse polio rounds is `improving’.
  • “Excellent” surveillance system in place.
  • Large scale social mobilization operation in India that cuts across several barriers (during pulse polio rounds).

The Costs

  • More than Rs 5000 crores have already been spent.
  • Higher priority health problems have receded to the background.
  • Even routine immunization has suffered, as evidenced by higher number of cases of traditional VPDs.
  • No mention of VAPP at all in the grand reports of covering 170 million per NID and 67 million per SNID.
  • Fatigue at all levels.
  • Confidence of public and professionals shaken.
  • A close look shows that with the current strategy “polio cannot be eradicated”.
  • No definite plan available for post eradication scenario or if there is a failure to achieve zero WPV status.

Conclusion 1: Continuing circulation of the wild polio virus in a few states, despite intensified pulse polio activities, with multiple changes in strategies and interventions, is a matter of serious concern.  At the same time a large number of states which have been free of WPV for last several years are being unnecessarily being exposed to hazards of VAPP due to OPV.

Recommendation: Strategies need to be reviewed by setting up a National Expert Group.  Possible use of IPV (alone or in combination with OPV) needs to be considered strongly. (See also Conclusion/Recommendation 4).

Conclusion 2: There is an alarming increase in number of clinical AFP cases, particularly in the states of UP and Bihar.  Such high incidence on non-polio AFP has not been reported from anywhere else in the world.

Recommendation: These reported cases need thorough evaluation, including clinical follow-up, to assess the possible causes and sequelae thereof.  There is also an urgent need of establishing an independent agency (separate from NPSP) for carrying out surveillance activities and their review.

Conclusion 3: Administration of multiple doses of mOPV1 in a pulse manner to a very large number of children in different states of the country is unprecedented.  It is alarming that the same is being done as phase IV clinical trial without following the established national guidelines for such trials.

Recommendation: There is a need to immediately evaluate the impact and side effects, if any, of the use of multiple doses of mOPV1.

Conclusion 4: At present there does not appear to be a coherent policy for the future keeping in mind the possibilities of: (a) pockets of continuing circulation of WPV; or (b) ultimate cessation of circulation of WPV.

Recommendation: There is a need for an independent National Expert Group to consider future strategies, which would be best, suited to our country within the overall objectives of the Global Polio Eradication Initiative.  The feasibility and desirability of introducing IPV and the suitable timing for the same also needs to be examined by this expert group.  There is urgency for deciding on these issues with a view to establish and achieve self-sufficiency in manufacturing of IPV in the country, if it is considered desirable to introduce IPV in the immunization programme.

Conclusion 5: The number of cases of VAPP is not available in the public domain.  It is not known whether any effort is even being made to delineate cases of VAPP.

Recommendation: District wise and state wise data on VAPP should be made available on a regular basis.  Efforts must also be made to assess VAPP among contacts of Vaccinnees.  It is also important that the state initiates a comprehensive programme of rehabilitation and possibly compensation for the victims of VAPP.