Friday 1 February 2008

Convention on Pharmaceuticals and People

Proceedings of Delhi Convention on Pharmaceuticals and People



10 Dec; All the initiative of FMRAI, other constituent organisations of Janswastha Avhijan like AIDAN and NCCPD together organised a national convention on ‘Pharmaceutical Policy and People’ at Banga Sanskriti Bhavan Auditorium at Delhi on 5th December.



The convention was inaugurated by Tapan Sen, M.P. and member of Consultative Committee on Chemicals and Fertilisers Ministry. Sen said people should be sensitized so that they take up medicine prices as one of the major issues. No where such a high margin of 150% to the production cost is allowed. This is not enough, difference between whole sale and retail price of many medicines are abnormally large. There are many other issues related to medicines which need to be taken up to the people. He said that the helpless nature of the Government had also affected the service and working conditions of the medical and sales representatives which is being countered well by FMRAI.



Presenting the theme of the convention Dr. Amit Sen Gupta said that Indian companies are described as copy-cats of patented medicines which is unjust since drug research in India has outbited multinational demonstration in the market. Certain safeguards have been provided in the amended patents Act but the Government is reluctant to use them. While some countries have used compulsory license to bring down prices of medicines, our Government expressed it as last resort thus have not used this safeguard.



Shantashree Chatterjee, MP said that even after 60 years of independence, we are to fight for a proper pharmaceutical policy. The healthcare system in the country is in shamble. He expressed that the convention would take up action plans which he would take up in the parliament.



Dr. Anant Pahdke from SATHI-CEHAT explained how primary health care is deliberately neglected. He said that all essential medicine should be available in all PHCs. He made several suggestions towards improvement of procurement and free of cost distribution of medicines for primary health care.



Dr. Mira Shiva of AIDAN explained the serious situation evolving out of irrational hazardous medicines. The industry is now exposing Indian women to dangerous medicines like RU-46, HRT, etc. She claimed that medicines for elderly persons should be given free of cost.



Dr. R. Senthil, MP, Secretary of Medical Parliamentarian’s Forum appreciated the initiative taken through the convention. He emphasised that health care is yet a service but not an industry. He also expressed concern that doctors are prescribing irrational medicines while IMA is yet to say against rise of prices of medicines. Similarly spurious medicines is also a big issue. He assured that all these important issues would be taken up by him in the Parliament and his Forum.



Arun Jha, Member Secretary, National Pharmaceutical Pricing Authority (NPPA) mentioned that 60 million people in India have no access to medicine is a shameful condition. Yet those who consume are severely exploited. He appreciated the note circulated by FMRAI. The commence could be empowered with better knowledge if such meetings are held more, he said.



Dr. Ram Chandra Dem, MP, expressed that there is serious lack of co-ordination among the Health Ministry, Chemical Ministry and the Commence Ministry which prevents forming a good policy. Issue of prices, irrational medicines, essential medicines, access to medicines should be taken for larger action to develop a rational pro-people medicine policy.



1.

Dr. Sujan Chakraborty, MP, appreciating the role of the organisers of the convention he said that health should form a pivotal national issue. He emphasised that public sector companies should be utilised for more availability of medicines. All process of approval and licensing should be centralised through National Drug Authority. The Government should constitute a separate Ministry for pharmaceuticals pulling out all fragmented systems of pricing, production, patents, quality, etc. from so many different Ministries.



Dr. C. M. Gulati, Editor of MIMS spoke with evidences that 18.56% of total sales of pharmaceuticals goes to promotion. He strongly felt that all marketing system should be strictly regularated. Dealing with the ills of clinical trials conducted in India he described how injury to peoples health is conducted utilising lack of vigilance of the Government and inadequacy of law.



Dr. Anurag Gupta, Janarogya Andolan spoke about anomalous situation on medicine prices. Citing examples, he presented how fallacious is price fixation system among brands, among different molecules exists. He demanded that all such injustices and irrationality should be stopped.



D. P. Dubey, General Secretary, FMRAI explained the demand of formation of all public sector medicine companies under a single one. This company will plan for production and distribution of all essential medicines.



Dr. Gopal Dabade, Karnataka Drug Action Forum and AIDAN explained the grave situation generated by the multinational Novartis Company when they challenged India Patents Act. Though Chennai High Court had rejected their case yet the company has filed another case. Consequences of such activity would come heavily on so many similar cases filed by many other companies which will force people pay very high prices of medicines. He described global actions taken against Novartis and gave a call for movement on Novartis Boycott.



The convention adopted a resolution after debate and suggestions emerged from the participants.



Draft Resolution



The Convention on “Pharmaceutical Policy and People”, organised by the Federation of Medical Representatives Associations of India (FMRAI), the Jan Swasthya Abhiyan (JSA), the All India Drug Action Network (AIDAN), and the National Campaign Committee on Drug Policy (NCCDP), held at Delhi on 5th December, 2007, in Delhi, adopts the following resolution.



Formulation of a National Pharmaceutical Policy

1. There is a the need to formulate a National Pharmaceutical Policy that addresses the critical issue of universal access to essential medicines and of national self-reliance. This policy should be prepared by an intersectoral committee of the Ministry of Health & Family Welfare and Ministry of Chemicals & Fertilizers after discussions with all sections that have a stake in the pharmaceutical sector. The two should jointly constitute a National Drugs and Therapeutic Authority, which should be a statutory body with powers to regulate all aspects of the National Pharmaceutical Policy. Apart from experts, this body should also include representatives from the health movement.



Self Reliant Production and Distribution

Given the increasing erosion in self reliance as regards production of medicines in our country, it is important that the Government monitor production of all essential medicines in the List of Essential Medicines prepared by the Ministry of Health and Family Welfare. This should be done with a view to ensuring production and availability of these medicines and it should be accompanied by a regular revision of the Essential Drugs List every two years.
To ensure production from the basic stage, ratio parameters between manufacture of formulation and bulk drugs should be reintroduced and production control mechanisms should be introduced to ensure that all manufacturers produce a certain proportion of drugs from the National List of Essential Medicines.
The production of drugs for the poor and the neglected diseases can only be ensured by making public sector companies major producers in these areas. The Govt should constitute a single company comprising of all public sector medicines companies run by the Central Govt. The company should be provided support in the form of adequate resources, access to technology, sectoral reservation, preferential treatment in the cases of Govt. purchases, etc.
For procurement of medicines for public institutions the Government should follow the model of pooled purchasing of drugs followed successfully in some states like Tamilnadu, based strictly on the Essential Medicines List.


Price Control and Regulation
It is estimated that expenditure on medicines in India constitutes more than half of the total health care expenditure and further that 80% of health care expenditure is met by patients themselves. It is thus clear that medicine prices act as a serious impediment in the access to essential medicines. Over the past two decades the pharmaceutical industry has been allowed increasing freedom to hike prices of medicines. The industry is also known to circumvent, and in many cases, violate existing regulations of price control. To remedy the situation the convention urges upon the government to:

Bring all medicines under price control, using mechanisms that are transparent and easy to administer. The system of price control should benefit the efficient producer. In no case should the mark up allowed be more than 100%.
Excise Duty on all essential medicines should be abolished. The NPPA should be provided with the infrastructure to monitor prices of all medicines and should be empowered to prosecute companies for violation of price regulations.
All illegal profits earned by companies, in violation of price regulations, should be recovered a special Tribunal should be established for this purpose, with a clear time frame of action.
Prices of all bulk medicines should be under price control.
No differential ceiling prices should be allowed.
One ceiling price for all medicines.


Fake/Counterfeit Medicines:

The Drugs and Cosmetics Act, should be amended so as to provide for stringent and deterrent punishment to be the fake medicine makers and sellers. An empowered commission should investigate the continued menace posed by production and sale of fake medicines, and such a commission should have adequate representation from consumers.
State level cells should be constituted to gather complaints from consumers and to recommend appropriate actions.
Unethical business practices like dumping of sales across state borders to evade taxes, suspension of sales, and sale of medicines intended for institutional procurement in the open market, should also be investigated and punished.


Irrational Medicines:

The recent release, by the DGCI, of a list of over 300 fixed dose combinations (FDCs) that have not been approved by any Drug Regulatory Agency in India, points to the rampant violation of law in the country and the consequent proliferation of irrational medicines. The list circulated by the DGCI is grossly inadequate, and also does not include a very large number of irrational medicines that have been approved based on incorrect premises. In this context the Convention urges the Government to:

As an immediate measure, prepare a comprehensive list of drugs and their combinations that are being sold in the market but have never been approved by regulatory agencies in India. Such a list should be immediately circulated in all news papers, including mention of the corresponding Brands of these illegal medicines.
All these FDCs should be declared banned under Sec.26A of Drugs & Cosmetics Act.
All state Licensing Authorities should be given a strict timeframe, within which they should be required to withdraw such illegal FDCS, and any delay on this count should be punishable.
Set up a special committee to weed out all irrational medicines and their combinations, including those that have been approved based on erroneous considerations, within a stipulated period.
Henceforth medicines and fixed dose combinations which are not mentioned in standard text books and other such authentic sources of pharmacological information should not be allowed to be marketed. Medicines banned in other countries having developed regulatory agencies [or in the country of origin] should be stringently evaluated, in this context.
For registration and production of all new medicines and their combinations, a single system of control should be introduced.
All existing medicines should be re-evaluated at regular intervals on the basis of expert opinion on their rationality, efficacy, and need.
No change of ingredient of a particular brand should be allowed.
The definition of a drug, as provided in the Drugs and Cosmetics Act, should be applied strictly, so as not to allow exceptions for irrational medicines like “tonics”, “anti-oxidants” etc.


Indian Patent Act

The Government should keep advocating for keeping TRIPS out of the WTO and also advocate for reopening the issue of exempting developing countries from providing for Product Patents in the case of medicines.
It should ensure that all the flexibilities in the Act are used to promote health and development of the domestic drug industry.
The Government should closely monitor the application of Patentability criteria for granting of Patents to ensure that trivial Patents are not allowed and ever greening of existing Patents does not take place.
The Government should liberally interpret the Doha Declaration of 2001 by declaring situations of emergency/urgency in the case of diseases that are present in epidemic or endemic forms or where their prevalence constitutes a health emergency. In such situations Compulsory licenses should be issued without delay.
Govt. should also facilitate the issue of compulsory licenses to remedy situations of non availability or high price of a patented drug or where an export is not being addressed.
Provision of Data Exclusivity is not a requirement under the TRIPS agreement, and should not be provided for now or in the future.
The Government should ensure that the challenge by Novartis to the rejection of its Patent application for its anti-cancer drug (Gleevec) is adequately contested, and that the earlier ruling of the Patent Controller, rejecting the Patent application, is not overturned.
The Government should immediately appoint a new committee to replace the now disgraced Mashelkar committee, in order to examine afresh the twin issues of (i) definition of a pharmaceutical entity, (ii) patenting of micro-organisms. The report of the Mashelkar Committee, which still finds place on Government websites, should be categorically rejected by the Government.
The Government should set up a cell under the aegis of the Ministry of Health, that would have the responsibility to examine all Patent applications that relate to Health, in order to give a final opinion to the Patents office whether the application conforms to the three basic requirements of patentability – novelty, usefulness and commercial application. A similar mechanism exists in Brazil and the Indian Government could draw from that experience.


Unethical Promotion:

The Magic Remedies (Objectionable Advertisement) Act, 1954 being outdated should be scrapped. A code of ethics for all prescription and OTC medicines should be prepared and be incorporated to Drugs & Cosmetics Act.


Programme of Action
Based on the above demands the convention decides to take up the following activities:

a) Campaign Committees be formed in all States.

b) Campaign for revitalisation of the public sector and observe a day when a nationwide call would be given to promote this campaign.

c) Deputations to meet state drug controllers for regulation of prices and weeding out of irrational medicines.

d) Consider filing a Public Interest Litigation and/or initiate other measures for weeding out of irrational medicines.

e) A campaign booklet shall be prepared listing the areas of concern, to take forward the campaign.

f) Organise Public hearing on medicine prices and irrational medicines.

g) Discussion with the concerned Ministries to be sought for pursuing the above demands.

h) Launch a wide campaign against unethical business practices and unethical promotion by drug companies, and follow up with the filing of specific complaints to relevant agencies against such practices.

i) Campaign among the medical students and medical practitioners on issues related to rational use of drugs.

j) Promote and intensify the Boycott Novartis Campaign among medical professionals till Novartis ceases its challenge against the rejection of its Patent application on Gleevec.

k) Campaign on unethical promotion among the medical community

l) JSA urges upon the Ministry to ensure availability of anti-anemic medicines and shall develop state wise campaign for makig thm available.







































Proceedings of Delhi Convention on Pharmaceuticals and People



10 Dec; All the initiative of FMRAI, other constituent organisations of Janswastha Avhijan like AIDAN and NCCPD together organised a national convention on ‘Pharmaceutical Policy and People’ at Banga Sanskriti Bhavan Auditorium at Delhi on 5th December.



The convention was inaugurated by Tapan Sen, M.P. and member of Consultative Committee on Chemicals and Fertilisers Ministry. Sen said people should be sensitized so that they take up medicine prices as one of the major issues. No where such a high margin of 150% to the production cost is allowed. This is not enough, difference between whole sale and retail price of many medicines are abnormally large. There are many other issues related to medicines which need to be taken up to the people. He said that the helpless nature of the Government had also affected the service and working conditions of the medical and sales representatives which is being countered well by FMRAI.



Presenting the theme of the convention Dr. Amit Sen Gupta said that Indian companies are described as copy-cats of patented medicines which is unjust since drug research in India has outbited multinational demonstration in the market. Certain safeguards have been provided in the amended patents Act but the Government is reluctant to use them. While some countries have used compulsory license to bring down prices of medicines, our Government expressed it as last resort thus have not used this safeguard.



Shantashree Chatterjee, MP said that even after 60 years of independence, we are to fight for a proper pharmaceutical policy. The healthcare system in the country is in shamble. He expressed that the convention would take up action plans which he would take up in the parliament.



Dr. Anant Pahdke from SATHI-CEHAT explained how primary health care is deliberately neglected. He said that all essential medicine should be available in all PHCs. He made several suggestions towards improvement of procurement and free of cost distribution of medicines for primary health care.



Dr. Mira Shiva of AIDAN explained the serious situation evolving out of irrational hazardous medicines. The industry is now exposing Indian women to dangerous medicines like RU-46, HRT, etc. She claimed that medicines for elderly persons should be given free of cost.



Dr. R. Senthil, MP, Secretary of Medical Parliamentarian’s Forum appreciated the initiative taken through the convention. He emphasised that health care is yet a service but not an industry. He also expressed concern that doctors are prescribing irrational medicines while IMA is yet to say against rise of prices of medicines. Similarly spurious medicines is also a big issue. He assured that all these important issues would be taken up by him in the Parliament and his Forum.



Arun Jha, Member Secretary, National Pharmaceutical Pricing Authority (NPPA) mentioned that 60 million people in India have no access to medicine is a shameful condition. Yet those who consume are severely exploited. He appreciated the note circulated by FMRAI. The commence could be empowered with better knowledge if such meetings are held more, he said.



Dr. Ram Chandra Dem, MP, expressed that there is serious lack of co-ordination among the Health Ministry, Chemical Ministry and the Commence Ministry which prevents forming a good policy. Issue of prices, irrational medicines, essential medicines, access to medicines should be taken for larger action to develop a rational pro-people medicine policy.



1.

Dr. Sujan Chakraborty, MP, appreciating the role of the organisers of the convention he said that health should form a pivotal national issue. He emphasised that public sector companies should be utilised for more availability of medicines. All process of approval and licensing should be centralised through National Drug Authority. The Government should constitute a separate Ministry for pharmaceuticals pulling out all fragmented systems of pricing, production, patents, quality, etc. from so many different Ministries.



Dr. C. M. Gulati, Editor of MIMS spoke with evidences that 18.56% of total sales of pharmaceuticals goes to promotion. He strongly felt that all marketing system should be strictly regularated. Dealing with the ills of clinical trials conducted in India he described how injury to peoples health is conducted utilising lack of vigilance of the Government and inadequacy of law.



Dr. Anurag Gupta, Janarogya Andolan spoke about anomalous situation on medicine prices. Citing examples, he presented how fallacious is price fixation system among brands, among different molecules exists. He demanded that all such injustices and irrationality should be stopped.



D. P. Dubey, General Secretary, FMRAI explained the demand of formation of all public sector medicine companies under a single one. This company will plan for production and distribution of all essential medicines.



Dr. Gopal Dabade, Karnataka Drug Action Forum and AIDAN explained the grave situation generated by the multinational Novartis Company when they challenged India Patents Act. Though Chennai High Court had rejected their case yet the company has filed another case. Consequences of such activity would come heavily on so many similar cases filed by many other companies which will force people pay very high prices of medicines. He described global actions taken against Novartis and gave a call for movement on Novartis Boycott.



The convention adopted a resolution after debate and suggestions emerged from the participants.



Draft Resolution



The Convention on “Pharmaceutical Policy and People”, organised by the Federation of Medical Representatives Associations of India (FMRAI), the Jan Swasthya Abhiyan (JSA), the All India Drug Action Network (AIDAN), and the National Campaign Committee on Drug Policy (NCCDP), held at Delhi on 5th December, 2007, in Delhi, adopts the following resolution.



Formulation of a National Pharmaceutical Policy

1. There is a the need to formulate a National Pharmaceutical Policy that addresses the critical issue of universal access to essential medicines and of national self-reliance. This policy should be prepared by an intersectoral committee of the Ministry of Health & Family Welfare and Ministry of Chemicals & Fertilizers after discussions with all sections that have a stake in the pharmaceutical sector. The two should jointly constitute a National Drugs and Therapeutic Authority, which should be a statutory body with powers to regulate all aspects of the National Pharmaceutical Policy. Apart from experts, this body should also include representatives from the health movement.



Self Reliant Production and Distribution

Given the increasing erosion in self reliance as regards production of medicines in our country, it is important that the Government monitor production of all essential medicines in the List of Essential Medicines prepared by the Ministry of Health and Family Welfare. This should be done with a view to ensuring production and availability of these medicines and it should be accompanied by a regular revision of the Essential Drugs List every two years.
To ensure production from the basic stage, ratio parameters between manufacture of formulation and bulk drugs should be reintroduced and production control mechanisms should be introduced to ensure that all manufacturers produce a certain proportion of drugs from the National List of Essential Medicines.
The production of drugs for the poor and the neglected diseases can only be ensured by making public sector companies major producers in these areas. The Govt should constitute a single company comprising of all public sector medicines companies run by the Central Govt. The company should be provided support in the form of adequate resources, access to technology, sectoral reservation, preferential treatment in the cases of Govt. purchases, etc.
For procurement of medicines for public institutions the Government should follow the model of pooled purchasing of drugs followed successfully in some states like Tamilnadu, based strictly on the Essential Medicines List.


Price Control and Regulation
It is estimated that expenditure on medicines in India constitutes more than half of the total health care expenditure and further that 80% of health care expenditure is met by patients themselves. It is thus clear that medicine prices act as a serious impediment in the access to essential medicines. Over the past two decades the pharmaceutical industry has been allowed increasing freedom to hike prices of medicines. The industry is also known to circumvent, and in many cases, violate existing regulations of price control. To remedy the situation the convention urges upon the government to:

Bring all medicines under price control, using mechanisms that are transparent and easy to administer. The system of price control should benefit the efficient producer. In no case should the mark up allowed be more than 100%.
Excise Duty on all essential medicines should be abolished. The NPPA should be provided with the infrastructure to monitor prices of all medicines and should be empowered to prosecute companies for violation of price regulations.
All illegal profits earned by companies, in violation of price regulations, should be recovered a special Tribunal should be established for this purpose, with a clear time frame of action.
Prices of all bulk medicines should be under price control.
No differential ceiling prices should be allowed.
One ceiling price for all medicines.


Fake/Counterfeit Medicines:

The Drugs and Cosmetics Act, should be amended so as to provide for stringent and deterrent punishment to be the fake medicine makers and sellers. An empowered commission should investigate the continued menace posed by production and sale of fake medicines, and such a commission should have adequate representation from consumers.
State level cells should be constituted to gather complaints from consumers and to recommend appropriate actions.
Unethical business practices like dumping of sales across state borders to evade taxes, suspension of sales, and sale of medicines intended for institutional procurement in the open market, should also be investigated and punished.


Irrational Medicines:

The recent release, by the DGCI, of a list of over 300 fixed dose combinations (FDCs) that have not been approved by any Drug Regulatory Agency in India, points to the rampant violation of law in the country and the consequent proliferation of irrational medicines. The list circulated by the DGCI is grossly inadequate, and also does not include a very large number of irrational medicines that have been approved based on incorrect premises. In this context the Convention urges the Government to:

As an immediate measure, prepare a comprehensive list of drugs and their combinations that are being sold in the market but have never been approved by regulatory agencies in India. Such a list should be immediately circulated in all news papers, including mention of the corresponding Brands of these illegal medicines.
All these FDCs should be declared banned under Sec.26A of Drugs & Cosmetics Act.
All state Licensing Authorities should be given a strict timeframe, within which they should be required to withdraw such illegal FDCS, and any delay on this count should be punishable.
Set up a special committee to weed out all irrational medicines and their combinations, including those that have been approved based on erroneous considerations, within a stipulated period.
Henceforth medicines and fixed dose combinations which are not mentioned in standard text books and other such authentic sources of pharmacological information should not be allowed to be marketed. Medicines banned in other countries having developed regulatory agencies [or in the country of origin] should be stringently evaluated, in this context.
For registration and production of all new medicines and their combinations, a single system of control should be introduced.
All existing medicines should be re-evaluated at regular intervals on the basis of expert opinion on their rationality, efficacy, and need.
No change of ingredient of a particular brand should be allowed.
The definition of a drug, as provided in the Drugs and Cosmetics Act, should be applied strictly, so as not to allow exceptions for irrational medicines like “tonics”, “anti-oxidants” etc.


Indian Patent Act

The Government should keep advocating for keeping TRIPS out of the WTO and also advocate for reopening the issue of exempting developing countries from providing for Product Patents in the case of medicines.
It should ensure that all the flexibilities in the Act are used to promote health and development of the domestic drug industry.
The Government should closely monitor the application of Patentability criteria for granting of Patents to ensure that trivial Patents are not allowed and ever greening of existing Patents does not take place.
The Government should liberally interpret the Doha Declaration of 2001 by declaring situations of emergency/urgency in the case of diseases that are present in epidemic or endemic forms or where their prevalence constitutes a health emergency. In such situations Compulsory licenses should be issued without delay.
Govt. should also facilitate the issue of compulsory licenses to remedy situations of non availability or high price of a patented drug or where an export is not being addressed.
Provision of Data Exclusivity is not a requirement under the TRIPS agreement, and should not be provided for now or in the future.
The Government should ensure that the challenge by Novartis to the rejection of its Patent application for its anti-cancer drug (Gleevec) is adequately contested, and that the earlier ruling of the Patent Controller, rejecting the Patent application, is not overturned.
The Government should immediately appoint a new committee to replace the now disgraced Mashelkar committee, in order to examine afresh the twin issues of (i) definition of a pharmaceutical entity, (ii) patenting of micro-organisms. The report of the Mashelkar Committee, which still finds place on Government websites, should be categorically rejected by the Government.
The Government should set up a cell under the aegis of the Ministry of Health, that would have the responsibility to examine all Patent applications that relate to Health, in order to give a final opinion to the Patents office whether the application conforms to the three basic requirements of patentability – novelty, usefulness and commercial application. A similar mechanism exists in Brazil and the Indian Government could draw from that experience.


Unethical Promotion:

The Magic Remedies (Objectionable Advertisement) Act, 1954 being outdated should be scrapped. A code of ethics for all prescription and OTC medicines should be prepared and be incorporated to Drugs & Cosmetics Act.


Programme of Action
Based on the above demands the convention decides to take up the following activities:

a) Campaign Committees be formed in all States.

b) Campaign for revitalisation of the public sector and observe a day when a nationwide call would be given to promote this campaign.

c) Deputations to meet state drug controllers for regulation of prices and weeding out of irrational medicines.

d) Consider filing a Public Interest Litigation and/or initiate other measures for weeding out of irrational medicines.

e) A campaign booklet shall be prepared listing the areas of concern, to take forward the campaign.

f) Organise Public hearing on medicine prices and irrational medicines.

g) Discussion with the concerned Ministries to be sought for pursuing the above demands.

h) Launch a wide campaign against unethical business practices and unethical promotion by drug companies, and follow up with the filing of specific complaints to relevant agencies against such practices.

i) Campaign among the medical students and medical practitioners on issues related to rational use of drugs.

j) Promote and intensify the Boycott Novartis Campaign among medical professionals till Novartis ceases its challenge against the rejection of its Patent application on Gleevec.

k) Campaign on unethical promotion among the medical community

l) JSA urges upon the Ministry to ensure availability of anti-anemic medicines and shall develop state wise campaign for makig thm available.

Tuesday 29 January 2008

UN Report: Maternal Mortality Rate Still On Rise In Developing Countries

The mortality rates of pregnant women in developing countries is still on the rise, a United Nations report issued on Friday said. More than half a million women die in pregnancy or childbirth each year, a little change from 20 years ago, the report said.

And 20 million unsafe abortions, a major factor in maternal deaths and illness, are done annually. The number of deaths is being reduced too slowly to achieve United Nations-set goals set by the Millennium Development Goals.

If no action is taken, a key global target of 75 percent reduction in maternal deaths by 2015 will not be met, the health agency has warned.

According to the report compiled by the World Health Organization (WHO), United Nations Children's Fund (UNICEF) and Population Fund (UNFPA), and the World Bank, 536,000 women died of maternal causes in 2005 compared to 576,000 in 1990.

Ninety-nine percent of the deaths occurred in developing countries; it said adding that several causes are responsible for deaths including poverty, hunger and disease.

AFP reports that Millennium Development Goal number five calls for the maternal mortality ratio, the number of maternal deaths per 100,000 live births, to be cut by 5.5 percent a year until 2015.

The maternal mortality rate was disproportionately high in developing nations, where there were "450 maternal deaths per 100,000 live births. This is in great contrast to nine in developed regions," the report said.

"Slightly more than one half of the maternal deaths (270,000) occurred in the sub-Saharan Africa region, followed by South Asia (188,000). Together, these two regions accounted for 86 per cent of the world's maternal deaths in 2005," it said.

According to WHO reports, the number of women dying in childbirth varies dramatically worldwide from one in eight in Afghanistan and Sierra Leone to one in 47,000 in Ireland.

Malnutrition, an ugly reality of modern India

Malnutrition, an ugly reality of modern India
Hungry and helpless — malnutrition is still one ugly reality of modern day India and it seems as if things are not about to get better anytime soon.
The third round of the National Family Health Survey carries a shocking report that over past six years, malnutrition in the country for children below three years has gone down by only 1 per cent.
This along with a UNICEF report shows that India has the highest rate of malnutrition in the world today.
"Not having enough of food can cause a lot of deficiency by way of macro-nutrients like carbohydrates, fats and proteins or even micro-nutrients like zinc, iron and magnesium," says Paediatrician, Max Healthcare, Dr Indra Vij.
One reason as per the Ministry of Women and Child Development is that no special budget was allocated for the malnutrition problem until 2004-2005. The Centre has also been laidback in providing supplement nutrition to the affected states.
Finally more attention has been given to increasing coverage area then ensuring better distribution. End result — today about 60 million children below five are underweight.
"You would find that the child does not grow according to his age. His nervous and general development may also be stunted," says Dr Vij.
In Arunachal Pradesh, malnutrition rate has increased by as much as 12 per cent followed by 8 per cent in Meghalaya, 7 per cent in Haryana and 6 per cent in Madhya Pradesh.
The Madhya Pradesh government has now launched project 'Shaktimaan' supported by the UNICEF to reduce malnutrition and spread health awareness, but one can find simpler solutions at home.
"Whatever food is available to people in rural area, even if it's just rice and daal, should be eaten. They can pick up any green vegetables and eat them. One can also ferment or par-boil foods," says Dr Vij.
Hungry Kya is one fun slogan that urban India is well familiar with. But in a country where so many children are hungry, this perhaps becomes a little ironical.

VARIOUS PROGRAMMES UNDER HEALTH DEPARTMENT

VARIOUS PROGRAMMES UNDER HEALTH DEPARTMENT

NATIONAL AIDS CONTROL PROGRAMME
NATIONAL CANCER CONTROL PROGRAMME
DRUG DE-ADDICTION PROGRAMME
DRUG CONTROL PROGRAMME
PREVENTION OF FOOD ADULTERATION PROGRAMME
FAMILY WELFARE PROGRAMME
MENTAL HEALTH PROGRAMME
MCH PROGRAMME
NATIONAL DISEASES SURVEILLANCE
NATIONAL PROGRAMME FOR CONTROL OF BLINDNESS
NATIONAL GOITER CONTROL PROGRAMME
NATIONAL TUBERCULOSIS CONTROL PROGRAMME
NATIONAL LEPROSY ERADICATION PROGRAMME
ORAL HEALTH SERVICES
REPRODUCTIVE & CHILD HEALTH CARE PROGRAMME
RCH SCHEME
RCH ACHIEVEMENT
NATIONAL SCHOOL HEALTH PROGRAMME
NATIONAL ANTI MALARIA PROGRAMME
VECTOR BORNE DISEASE CONTROL PROGRAMME
ICDS PROGRAMME
DISASTER MANAGEMENT PROGRAMME
WATER BORNE DISEASES
EMERGENCY SERVICES ETC.

DEVI RUPAK SCHEME

DETAILS OF DEVI RUPAK SCHEME
A scheme to promote one child norm and spacing of children

Population of Haryana as per 1971 census was 10.36 million, which rose to 16.46 million in the year 1991 showing a decadal growth rate of 27.4%. As per the 2001census, the population of the state is 21.08 million showing a decadal growth rate of 28.06%.

The birth rate of the state in the year 1971 was 42.1 per thousand, which has come down to 26.8 per thousand in the year 1999. To stabilize the population, birth rate has to be further brought down to 21.0 per thousand, which will correspond to total fertility rate of 2.1. As per the National Family Health Survey-II (1998-99) the Fertility Rate of Haryana is 2.88. Further, the sex ratio (females against 1000 males) of Haryana has declined from 870 in the year 1981 to 865 in the year 2001 which is a point of major concern.

In order to stabilize the population of the state and to check the declining trend in the sex ratio, apart from already existing spacing and permanent methods, some innovative scheme is felt to be introduced in the state which can sensitize the community towards the need of adopting one child norm and spacing of children. It is important to promote these ideas especially the newly weds

Keeping in view the above objectives, a scheme by the name "DEVI RUPAK" is proposed to be introduced. Introduction of this scheme will also augment the existing family welfare services and will motivate more and more couples to adopt these norms

The basic idea of "DEVI RUPAK" is to provide monthly incentive of up to Rs. 500 per month to a couple accepting a terminal method of family planning (i.e. Vasectomy or Tubectomy as the case may be) upon the birth of the first child or upon the birth of the second child provided both the children are girls for a period of 20 years, from the date of such acceptance


The amount of monthly incentive proposed to be given as under:-

Sr.No. Stage of adoption Incentive amount per mounth
1. At the birth of first girl child Rs.500

2. At the birth of first boy child Rs.200
3. At the birth of second girl child Rs.200

It is noteworthy that not a penny would be given gratis to any one. Every beneficiary of the scheme shall make a strong contribution to nation building as well. The scheme shall come into force from 25.9.2002


--------------------------------------------------------------------------------

Eligibility conditions:

To be eligible under the scheme a couple would have to get themselves registered with the local Gram Panchayat/ Municipal Committee within those jurisdiction the couple ordinarily resides.
None of the partners constituting the couple should be an income Tax payee.
A. For couples already married before 25.9.2002

The age of husband is 45 years or less and the age of wife is 40 years or less as on 25.9.2002 and neither of them has undergone sterilization before 25.9.2002.

1. If such couple already has only one child and wants to adopt the scheme one of the partners will have to adopt a terminal method of family planning upti 26.1.2003.

2. If such a couple does not have nay child as on 25.9.2002, they would have to get themselves registered under the scheme upto 26.1.2003 and one of the partners will have to adopt a terminal method of family planning within three months of birth of first child.

B. For couples who get married on or after 25.9.2002

1. The age of the husband on the date of marriage must have been at least 21 years and the age of the date girl on date of marriage must have bee 18 years.

2. Such a couple will have to register themselves with the Gram Panchayat/ Municipal Committee within 6 months of their marriage.

3. It shall be mandatory for the registered couples to ensure that the first child is not born upto a date which is at least two years from the date of their marriage. One of the partner shall have to adopt a terminal method of family planning within three months of the birth of the first child for the couple to become eligible under the scheme.

4. In case, neither of the partners adopts a terminal method of family planning within three months of the birth of the first girl child, it would again be mandatory for them to ensure that the second child is not born upto a date which is at least two years from the date of the birth of first child. One of the partners would have to adopt a terminal method of the family planning within three months of the birth of the second girl child for the couple to become eligible under the scheme.

PLATO ON HEALTH

The greatest mistake in the treatment of diseases is that there are physicians for the body and physicians for the soul, although the two cannot be separated.
~Plato

Body and soul cannot be separated for purposes of treatment, for they are one and indivisible. Sick minds must be healed as well as sick bodies.
~C. Jeff Miller


I got the bill for my surgery. Now I know what those doctors were wearing masks for.
~James H. Boren

A hospital should also have a recovery room adjoining the cashier's office. ~Francis O'Walsh

JSA BYCOTT

Jan Swasthya Abhiyan
(Peoples Health Movement – India)
Health for All - Now! Health is a Basic Human Right!
Press Release

For Favour of Publication

The Jan Swasthya Abhiyan (JSA http://phm-india.org/), comprising 18 national networks and hundreds of state level/local organisations engaged in promoting issues related to public health in India, announces a call to doctors to boycott all products manufactured by the Swiss MNC, Novartis, till Novartis withdraws it’s case before the Intellectual Property Appellate Board for seeking a patent on Gleevec and abandon all it’s attempts and plans to misuse the Indian decision making and redressal systems for it’s narrow ends.

The JSA has decided to issue the boycott call after prolonged deliberation, given the intransigent attitude shown by Novartis in obstructing access to a vital medicine for blood cancer. Novartis had first pressed for removal of a key public health safeguard in the Indian Patent Act and now continues to persist in pressing for a patent for its anti leukemia drug, Gleevec (beta crystalline form of Imatinib Mesylate), after its application was rejected by the Indian Patent office.

Imatinib mesylate is extremely useful in the treatment of chronic myeloid leukemia (CML) a type of blood cancer. In addition to Novartis, several Indian companies – viz. NATCO, Cipla, Ranbaxy and Hetero -- also produce and market this drug. Treatment with Gleevec (manufactured and marketed by Novartis) costs rupees 1,20,000 per month, whereas Indian companies market the same drug at a price of about Rs. 8,000 per month. If a patent were to be granted to Novartis for the beta crystalline form of imatinib mesylate, some Indian companies may have to stop production of this medicine, and this may drastically curtail the options for the patients to avail the far cheaper version of this life saving medicine. At a treatment cost of Rs.1,20,000 per month, this would mean that over 99% of patients requiring this drug would be denied access to it. The huge difference in the price of the same drug is an illustration of how a patent monopoly can be used by drug companies to generate super-profits while endangering the lives of thousands, or even millions.

Novartis has challenged the order of the Indian Patent office, rejecting its application for a patent on the beta crystalline form of imatinib mesylate. This case will be heard by the Intellectual Property Appellate Board. The Indian Patent office had rejected the application for a patent on sound principles, entirely consistent with the country’s laws and the agreement on Trade Related Intellectual Property Rights (TRIPS).

Novartis had filed a second case challenging the constitutional validity of Section 3(d) of the Indian Patents Act. Section 3(d) was specifically introduced by the Indian parliament as a safeguard against the misuse of product patents on medicines. It is a matter of grave concern that a foreign company chose to challenge the constitutionality of a law that has been passed by the Indian Parliament to safeguard public health. The consequences of a change in the safeguards in the Indian Patent Act would not be limited just to India. Today India is known globally as the “Pharmacy of the Third World”, because Indian companies export cheaper versions of patented drugs to over 150 countries. For example, over half the medicines currently used for AIDS treatment in developing countries come from India. Many reputed personalities publicly appealed to Novartis to






withdraw the court case. They include Erik Solheim, Minister of International Development, Norway and Henry Waxman, Chairman, Congress of United States. The Chennai High Court’s decision on 6th August, 2007 to dismiss Novartis’s plea has vindicated our stand. The Chennai Court said that it does not have jurisdiction to decide whether the Indian Patent law is TRIPS compliant or not; the appropriate forum, being the WTO Disputes Settlement Body.

Instead of giving up, however, Novartis has decided to pursue its case challenging the denial of a patent on Imatinib to be heard by the Intellectual Property Appellate Board! It has also appealed to the Chennai High Court again, this time asking for removal of Sri.Chandrashekharan from the Appellate Board as the company claims he is a biased party because he was involved in rejecting its patent claim on Gleevec earlier! Novartis has also held out a veiled threat in its response to the dismissal of its petition by the Chennai High Court. Chief Executive, Daniel Vasella, has been quoted by the Financial Times as saying: "This [ruling] is not an invitation to invest in Indian research and development, which we would have done. We will invest more in countries where we have protection. It's not a punishment. It's just a question of the culture for investment."

This is the background of JSA’ boycott appeal. We once again appeal to Novartis to desist in persisting to challenge the Indian legal system and in attempting to jeopardise the lives of millions. We appeal to the Medical community in India to unite in a show of opposition to the methods used by Novartis that compromise access to vital medicines, by signing the boycott letter issued by JSA or by signing the online petition at http://novartisboycott.org/. The two selling products marketed by Novartis in India are Voveran (a pain killer and anti-inflammatory drug) and Calcium Sandoz (a calcium supplement). We are sure that patients would not suffer because of this boycott, because good substitutes are available in India for all Novartis products. When and if a substitute is not available in a city/village for a Novartis product, we would urge doctors to boycott other Novartis products.


(Dr.B.Ekbal)
Convenor, Jan Swasthya Abhiyan

Addresses for Correspondence:
National Secretariat c/o SATHI CEHAT, 3&4, Aman Terrace, Plot No. 140, Dahanukar Colony, Kothrud, Pune 411029
Ph: (020) 5451413 / 5452325 Email: cehatpun@vsnl.con
National Secretariat, Delhi: D-158, Lower Ground Floor, Saket, New Delhi -110017.
Ph: (011) 26524324 , 26862716 (Telfax). Email: ctddsf@vsnl.co

Bycott Novartis

Dear Doctor/Colleague
The Novartis, a Swiss Multinational pharmaceutical company operating in India,has challenged the order of the Patent Office in Chennai, rejecting its application for a patent on
IMATINIB MESYLATE which Novartis markets in India under the trade name Gleevec. In the second application filed in the Chennai High Court, Novartis had challenged the
constitutional validity of Section 3(d) of the Indian Patents Act by claiming that this section does not comply with the TRIPs agreement
It is a matter of grave concern that a foreign company chose to challenge the constitution ability of a law that has been passed by the Indian Parliamentto safeguard public health. Members of the medical profession need to be particularly concerned about such attempted misuse of use of Indian Legal System.
As you would know, Imatinib mesylate is extremely useful in the treatment of chronic myeloid leukemia (CML).
Treatment with Gleevec (manufactured and marketed by Novartis) costs rupees 1,20,000 per month, whereas Indian companies ( Cipla/Ranbaxy) market the same drug at a price of about Rs. 8,000 per month.
If a patent were to be granted to Novartis for imatinib mesylate, some Indian companies may be forced to stop production of the drug denying access to it to 99% of patients. It will open the floodgates for the MNC’s so that they too can apply for trivial patents.
Haryana Vigyan manch and Jan Sawasthaya Abhiyan Haryana appeal to you as a medical Professional to bycott products that are manufactured and marketed by Novartis by refraining from prescribing drugs that are marketed by Novartis.

Sincerely Yours

R.S. Dahiya Ved Pirya
President Haryana Vigyan Manch Secretary ,Haryana Vigyan Manch
9812139001 9992132961