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INDEPENDENCE DAY CELEBRATIONS BY KARUNYA TRUST

On the historic occasion of the 60th Independence Day of India, Karunya Trust had its celebration in the various GroupGrampanchayats of Kalyan and Bedalapur Talukas.The Independence day celebration was marked by

various programmes in the respective villages.

Savarae Group Grampanchayat:

Karunya Trust in collaboration with the leaders of Savarae Panchayat and the local school management had celebrated Independence Day at Savarae School.

Mr.Babu Dabre , the surpanch of savarae GP had hoisted the flag at 7.30 am, followed by a message from the Gram Sevak. The children of the Primary school, members of SHG had actively participated in it. The Trust had distributed notebooks, pens, chocolates and biscuits to all the children in the school.

Bisol Group Gram Panchayat:

We had celebrated the Independence Day at Bisol, Anegaon, Nalambi with the Community. The Flag hoisting at Bisol was done by the Surpanch Mr. Kailas Jhadav ,followed by various cultural programmes organized to mark the celebration by the children. The Independence Day message was given by the Headmaster Mr. Ashok M. Fr. George the Director of Karunya Trust had distributed School uniforms, shoes, notebooks, and sweets to all the children. The members of the Farmers Club, Self-help groups, youth groups, and the entire community participated in it. The Headmasters of the respective schools thanked the Trust and appreciated the excellent works done in their villages so far. The Gramasabha assured their full support in the works ahead in the villages.

Attali : The Corporator Mr Dashrat Thare had hoisted the flag at Attali Village which comes under KDMC in the presence of local school children, parents, members of various associations like self-help groups ,youth groups etc. Karunya Trust had distributed prizes to the winners of essay and drawing competitions held prior to the celebrations.

Scholarship Distribution:

On the occasion of the Independence Day celebrations at Bisol GP Karunya Trust had honored the students who had secured the highest marks in the SSC & HSC examinations held in the year2005-06. The Director Fr.George Vattamattam gave the following students cash award from Anegaon, Bisol, and Nalambi.

Satish Vasant Choruge
Sunina Shivaji Karle
Ganesh Gajanan Suroshi
Sujatha Chintaman Mope
Asha Bohir
Ravindra Ganu Hirave
Ankush Bhagavan Bohir
Sukanya AnkushJhadav
Adhar Ramesh Garat

Visit to the Flood Affected Areas:

During the last heavy rain on 5 th to 8 th August lots of paddy fields were destroyed which was repaired under Cash For Work (CFW) in the Flood Rehabilitation Project .The Director Fr.George had visited the flood affected areas and had meeting with the farmers of Anae, and Bisol to plan out for the next step.

I sincerely thank the staff and the village leaders for their cooperation and support in carrying out the vision and mission of Karunya Trust.

Karunya Trust has launched its own website

Karunya Trust has launched its own website which was an unfulfilled dream for many years. When Bishop Thomas Elavanal, the Chairman of the Trust, pressed the key button of the computer at 12 noon on 26th July 2006 the dream became true for the benefactors and beneficiaries of the Trust.
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Karunya Trust will share its innovative activities and its messages & opinion through this website. Karunya offers this site as a valuable gift to the world as one more effective gesture to change the world into a better place where the peace and harmony exist. The site was hosted and managed by Blessing Wellness and Education Foundation. We specially thank Blessing Foundation for collaborating with Karunya Trust. Bishop Thomas Elavanal expressed his heartfelt gratitude to Blessing Foundation for the creation of Karunya Trust Website and minimizing the gap between the Trust and the society.

This website is launched on the occasion of the first anniversary of Maharastra Flood. Karunya Trust observed 26th July as Prayer Day to remember the victims of flood at Dharavi Slum at 12 noon.

Ms Varsha Gaikwad MLA, Bishop Thomas Elavanal, Ms. Shivakamy from CRS, Mr. Naresh, Municipal Counselor and many other dignataries took part in the event.

Prayer Day

26 th July 2005 was devastating day of Mumbaikers . Many left home for their livelihood but returned as dead bodies. Mumbai became for a day as Arabian Sea. Mumbaikers have hundred stories to say when they think about Mumbai flood. 26 th July, 2006 being Anniversary of Mumbai Flood, Karunya Trust organized a prayer service in remembrance of the victims of Mumbai Flood. The prayer service was organized at Dharavi Slum at 12 noon. The office staff of Karunya Trust Ms Eleen Chettri and Ms Kiran Shalini conducted the prayer service. Ms Varsha Gaikwad MLA, Bishop Thomas Elavanal, Ms. Shivakamy S.R, CRS, Mr. Naresh, Municipal Counselor many other dignataries took part in the event.

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Special homage was paid towards Dr. Virdthi, for his contribution towards Karunya Trust and Community. Bishop Thomas Elavanal, Ms. Shivakamy S.R, CRS, Ms Varsha Gaikwad, MLA and Messenger Fr. Jacob Porathur and wife of Late Dr Virdthj shared their condolence to the victims of the Maharashtra Flood.

Petition to the Hon. Prime Minister of India on the Proposed Amendment to the Drug and Cosmetics Act And Issue of Data Exclusivity by Rt. Rev.Dr.Thomas Elavanal (Chairman) and Rev. Fr. George Vattamattam (Director) Karunya Trust

Date: 24th July 2006
Dr. Manmohan Singh
Hon. Prime Minister of India
The Prime Minister’s Office
South Block, Raisna Hill
New Delhi


Subject: Comments on the Proposed Amendment to the Drug and Cosmetics Act And Issue of Data Exclusivity

Dear Hon. Prime Minister,

Karunya Trust is a Multi Religious Non-Governmental Organization, registered under Bombay Public Trust Act 1950. It stands for the noble ideals of the development of the society, as children its central point. The trust caters to the needs of the poor irrespective of cast, creed and religion. The main interventions are n the areas of education, health, and awareness about HIV/AIDS, care & support for PLHAS, empowerment of women and income generation programme. It also works for the relief operations in natural and man-made calamities. It operates in Mumbai & its suburbs and the remote villages of Maharashtra. It operates through its nodal centers established and spread over all parts of Maharashtra.

Karunya Trust , on behalf of thousands of poorest people to bring to your kind attention about the proposed Amendment of the Drug and Cosmetics Act. At present the availability of life saving medicines and other medicines are affordable by our poor people through Government Health Service System. In the past few years, availability of affordable generic medicines manufactured in India has made a tremendous change in the life expectancy and health of PLHAS (People Living With HIV/AIDS). This has changed the management of HIV/AIDS in India – from a life threatening disease to a manageable chronic disease. Their life depends on the assurance of Government of the continuous supply of affordable Generic Anti Retroviral Medicine (ART).

The costs of ART medicines (essential three combinations) from $ 10,439 per patient per year have come down to $ 150 (2001-2005) because of generic medicines production and its competition in India. At present the India Government of treating 20,000 PLHAs and force to increase the number of PLHAS in the coming years as our Country has 5.7 million HIV/AIDS people as per the record today.

We have come to know through the media reports that the India Government is considering an amendment to the Drug and Cosmetics Act. This move is apparently related to the India Government’s commitments under the TRIPS; agreement especially Article 39-3 of TRIPS. The clinical trial data that originator companies submit to Drug Regulatory Authorities (anywhere in the world) were the center of debate on Article Based on briefing note published by the World Health Organization.

We are writing this letter to you on behalf of thousands of poorest people about our strong concern on the issue of “Data Exclusivity” and its inclusion in the proposed amendment to Drug and Cosmetics Act. We strongly consider “Data Exclusivity” to be another threat on peoples’ health. India being the country with 36% of the population is under below the poverty line. This act will have direct impact on the Health Care Services to the poorest and vulnerable people of India. We urge you to consider these concerns and stop any move to amend the above Act, or include “Data Exclusivity” in any legislation. Looking forward to your early positive action in this regard.



OUR CONCERNS ON THE ISSUE OF DATA EXCLUSIVITY

The TRIPS agreement does not refer to any period of data protection, nor does it refer to data exclusivity.
This move to include ‘data exclusivity’ is a ‘TRIPS-plus’ agenda, which is anti-people and against people’s interest. It is being pushed by vested interests including large Multi-National Corporations and certain foreign governments.
Data exclusivity has become a means of preventing competition from Indian Manufacturers, which greatly restricts access to medicines.
It is unethical to conduct clinical trials on drugs, which have already been proven effective.
The cost of generic drugs and the costs of health care bound to increase, which is a wasteful expenditure, which a country like ours can ill-afford.
The civil society in the country and even expects from within the Government have opposed the amendment because of the impact it will have on people and people’s access to medicines.

Compliance with TRIPS

In complying with the TRIPS norms, India amended the Indian Patents Act in the year 1970 and second amendment was made two years back (2004) against much public opposition. This move to further alter Indian legislation to supposedly comply with TRIPS requirements is an unwarranted step. In fact, the TRIPS agreement does not refer to any period of data protection, nor does it refer to data exclusivity.

Article 39.3 of TRIPS says that WHO members should protect ”undisclosed test or other data” against “unfair commercial use” and “disclosure”. Nowhere does TRIPS state that countries should provide exclusive rights to the originator of the data for a given period. Rather, TRIPS simply refers generally to the need for “data protection”

Data protection against unfair commercial misuse as mentioned in TRIPS is totally different from data exclusivity. The use of data by the Drug Controller to compare bioavailability and bioequivalence data is a legitimate, non-commercial use and is TRIPS compliant.

TRIPS plus- An Anti-People Agenda

Preventing comparative use of data submitted for getting marketing license from the Drug Controller is definitely a TRIPS PLUS measure. Such measures are being forced on developing countries as part of many Free Trade Agreements and Bilateral Trade Agreements. In fact, the Report of the Commission on Intellectual Property Rights, Innovation and Public Health (CIPRIPH), of which Dr. R.A. Mashelkar was the Vice Chairperson has clearly cautioned countried from placing unnecessary data protection norms. In page 143, it clearly says “Article 39.3, unlike the case of patents, does not require the provision of specific forms of rights. It does not create property rights, nor a right to prevent others from relying on the data for the marketing approval of the same product by a third party, or from using the data except when unfair commercial practices are involved”.

Access to Drugs

It is clear that data exclusivity could prevent the registration of generic versions of medicines even when there is no patent on a medicine. Data exclusivity has become a means of preventing competition from Indian manufacturers, which greatly restricts access to medicines.

As the Global AIDS Alliance and the others working on ‘access to drugs’ have pointed out, such amendments will have adverse effects on the global availability of affordable essential medicines meant to treat HIV/AIDS, hypertension, diabetes, asthma and many other diseases. If ‘data exclusivity’ is applied, then companies would be prevented from taking marketing approval even if they have been granted compulsory license to use a patented substance during the period the data exclusivity is in operation.

Unethical practice

In addition to all the above problems, data exclusivity raises very important ethical questions. Entities desirous of making a generic drug would have to repeat clinical trials, which would be unethical as they would be conducting efficacy trials with compounds which have already been proven effective, while denying effective drugs to certain other people.

Health Care Costs

In a country where most of the spending on health is through out-of-pocket expenditure and the provision of government services is limited., any increase in cost of drugs is bound to adversely affect people’s access to drugs. a duplication of clinical trials is bound to increase the cost of drugs and is a wasteful expenditure which a country like ours can ill-afford. As the report of the CIPRIPH states, the UN Special Reporter on the Right to Health commented on the possible additional health-care costs relating to the introduction of data exclusivity in the Free Trade Agreement between the UN and Andean pact countries

Mismatched Responsibilities

The Drug Regulatory Authority is a body set up as Public Authority. Its function is to ensure public interest, that drugs that are provided with marketing approval meet the criteria of safety efficacy and good quality. Drug Regulatory Authorities need to be concerned with safety and efficacy of a drug, and are not supposed to involve themselves with that patent status of a drug. By amending the Drugs and Cosmetics Act, Drug Regulatory Authorities will be required to look at the status of a drug, which does not fall under their domain. Under the guise of Data Exclusivity, what is really being sought is that the Drug Regulatory Authorities should act on behalf of Pharmaceutical Companies to safeguard their monopoly right.

The recent WHO Briefing Note on Access to Medicines emphatically states that efforts to integrate the intellectual property system and the drug regulatory system via data exclusivity, “linkage” or other means are likely to have negative implications for access to medicines. It calls on countries to keep these systems separate, and to reject any and all efforts to make connections between them.

Opposition from Within

Experts on the issue, including experts from civil society, the Parliament Standing Committee on Commerce and the Ministers of Commerce and Health have opposed the amendment because of the impact it will have on people’s access to drugs and agro-chemical products. These views are to be taken into account while taking a decision of such extensive impact.

What is the Alternative?

Instead of seeking to further expand the scope and duration of ‘ exclusive rights’ of drugs and agro-chemical products, India should seek to encourage competition among Indian manufacturers.

A minor addition to the Drugs and Cosmetics Act, which says ‘test date provided by a company will not be made public or shared with its potential competitors for five years’ is enough to meet the requirements of TRIPS. This does not prevent the Drug Regulatory Authorities from relying on the data license a generic version of a new dug.

We therefore strongly urge you to take into consideration of Public Health Needs of patients in India and other developing countries when implementing Article 39-3 of TRIPS Agreement. We request you to ensure that Generic competition remains viable and possible in India. Many of our people are depending on it for access to affordable medicines worldwide.

The urgent need of the hour is to improve people’s access to drugs and to make drugs affordable. We hope that these issues will be taken up strongly in the new Drug Policy. For us your decision is a matter of Life and Death.

We hope to get a quick and positive response from you on this important burning issue.
Copy of Community campaign signature is also attached to it.


Yours Sincerely,

Rt. Rev.Dr.Thomas Elavanal	Fr. George Vattamattam
Chairman	Director




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