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@dp81 Bro for the first time, I am not understanding what you are trying to say !
Anyways, mai sone chala.
@dp81 and @all my bros : Please sleep early guys or you will feel sleepy as I did during my morning tests at chronicle. Trust me, it will affect your performance !
Clinical trials are usually conducted in different countries to check the therapeutic efficacy and safety of a drug with respect to different ethnicities.In India the process of regulation,oversight and monitoring is under Central Drug Standards control Organization which has come under scathing criticism from Parliamentary standing committee for clearing drugs without having trials in India and being a pro pharma organization. Moreover There have been many deaths and serious adverse effects also directly related to clinical trials.
Present weaknesses: informed consent document does not capture the full details of the subjects and in case of SAE they are left to fend for themselves CDSCO is understaffed and as a result 1000s of application are cleared without due scrutiny.Clear conflict of interest whether it has to promote more clinical trials or to look into safety of the patients Pharma companies usually gather the data and send it back to their home country drugs for which the trials being held do not cover the commonly found diseases in India
In wake of these shortcomings a clinical trial policy is a must and following can be its salient provisions: The informed consent process should be videotapped but confidentiality must be ensured All the ethics committee and sponsor should be registered and in case of any SAE all the medical expenses should be borne by them until it is resolved Drugs must only be approved if there is a clear case of public health benefits Any departure from the stipulated norms should lead to the cancellation or revocation of license of the ethics committee/sponsor
In given scenario of heavy burden of disease in India clinical trials role cannot be underemphasized .A well-defined policy that harmonizes the interest of all stakeholders viz sponsor,ethics committee and patient will go a long way in easing it.
1. Do you agree with “The conditions of the urban poor are more deplorable than that of their rural counterparts”. Also, Critically assess the impact of urbanization on the socio-economic situation in India.
Ans- Yes I agree. As far as the conditions of poor people are concerned, the urban poor are definitely deplorable as compared to that of their rural counterparts. The reasons being-
(a) Government policies are more focussed toward rural poor than urban poor. (b) The income gap & sociological differences are much wider in urban areas than rural areas. (c) Rising pollution & reducing sanitation in poor dwellings & slums are a common feature of urban areas. It increases the chances of health hazards. Rural regions are comparatively pollution free. (d) With rising commercialization in urban areas, the concern for poor people is much less in urban regions as compared to rural regions.
The socio-economic situation in India is very much affected by the rising urbanisation. It has numerous impacts which can be assessed as-
(a) Rising commercialization- Apart from increasing the gap between rich & poor, it is creating a sense of inferiority complex in the mind of deprived people. Moreover, it has given birth to a 'show-off' culture in major cities. (b) Rising Industrialization- Rising demands of people has turned the focus on rapid & more production of goods & services. It is beneficial for the country & is acting as a growth engine. On the other hand, it is leading to pollution, waste management problems, creation of a new labour class, illegal minings, illegal land acquisition etc. (c) Good standard of living- This factor is the outcome of previous two factors. Urbanisation has brought new avenues of employment, better facilities for health, education, communication, transport etc.
Overall, we can say that Rising Urbanisation is a coin with two sides of different shades. Proper planning & proactive steps by government can definitely improve the socio-economical status of India. Government has already took many steps in this direction like JNNURM, Anti pollution laws, Urban waste management & sewage treatment techniques etc & are most welcome.
I just think being the last week, the enthu for answer writing has died down and people are busy revising things, that brings this thread to a very premature agonizing death I suppose
1. Do you agree with “The conditions of the urban poor are more deplorable than that of their rural counterparts”. Also, Critically assess the impact of urbanization on the socio-economic situation in India 25M, 250W
Ans Yes, Urban poor have been forced to live in more deplorable conditions than their rural counterparts due to lack of government attention and adequate safety nets.
Govt. has introduced many poverty alleviation programmes for rural poor to address their chronic poverty like MGNREGA - Increased rural wages substantially and also helped in developing community assets NRLM - Support to rural entrepreneurship and improving skill sets and bulding income generating sources IAY - Build houses for BPL and APL SC/ST households TCS/NBA - Provide sanitation to all NRHM - Medical access to rural households
On the contrary govt. has been lethargic in addressing the urban issues
1. urban slum problem which is leading to ghettoisation - RAY,RRY were suppose to address the problem but the schemes have not been able to provide the desired results 2. Non-access to PDS being a non-local resident 3. High cost of living leading to alienation to basic amenities 4. Non-availability of medical facilities - Both in terms of accessibility and being priced out
If we look at the impact of urbanisation on socio-economic conditions, we can say it has led to:
1. Slums/Ghettoisation - High cost of land and housing and also unavailability of land has led to formation of slums 2. Resource crunch - The explosion of population has led to water crunch, deterioration in living conditions and poor sanitation 3. Increased Impoverishment - Migrant rural population are vulnerable and there are no safety nets, and the low wages with price rise and non-access to formal medical care leads to increased incidence of poverty
On the other hand, Urbanisation has created a strong middle class which has helped in increasing the growth prospects, a better governance system with transparency, a better standard of living for many people and most of all better education and medical facilities.
on the whole, we see that Rural-Urban migration and Urbanisation has its own pros and cons, but the pros outweigh the cons but we should be able to address the concerns of the migrant rural community by providing them with better safety nets, medical facilities which is now under NUHM and development of corridors under National Urbanisation Policy etc.
2. “A major vulnerability of India is the proliferation of illicit small arms and ammunitions manufactured overseas”.Despite this India and other nations abstained to sign the recent Arms Trade Treaty. Why? Comment on the validity of India’s stand and suggest measures to make ATT more conducive. 250W, 25M
Ans Arms Trade Treaty (ATT) was signed by many countries this year. It is a good step to regulate the flow and sale of arms but the agreement had its own loopholes and concerns which prompted countries like India to abstain.
ATT has certain provision like: 1. The seller of the arms can unilaterally cancel the arms sale agreement. 2. There is no provision for restriction of sales of arms to terrorists and non-state actors 3. There were no restrictions on arms being given as gifts or loans
India has objected to all the 3 provisions stated above and vouched for a more balanced ATT. It wanted the following provisions,
1. While exporting, the end user need to be mentioned 2. Also, exporter should not be allowed to unilaterally cancel the sales agreement and there should some sort of arbitration or agreement between the parties 3. gifts and sales to non-state actors and terrorists need to be controlled or banned as it leads to regional security issues
The Western countries did not consider these proposals and India had to abstain to show its dissent and also India feels the agreement in its present form would be disadvantageous to her as 1. She is one of the biggest weapons importer 2. Non-state actors threaten its internal security
3. Examine the relevance of the clinical trials in India under the growing cases of misuse of the standard process of informed consent of the participants. 15M, 150W
Ans Clinical trials are a necessity to understand the efficacy and the achievement of desired effect of the new vaccine/formulation which would lead to faster discoveries of newer drugs leading to eradication of many diseases in India.
India has hence implemented a very favorable and friendly clinical trial policy to achieve the same.
There have been many issues around clinical trials that are coming up and most of them are SAE (Severely Adverse Effect) cases which has concerned the relevant authorities.
Issues with clinical trials:
1. Consent of the individuals undergoing the trial is not taken and recorded properly 2. Most trials undertaken are for drugs to be uses in overseas markets and for measuring bioequivalence/efficacy of established drugs and not for newer drugs to address the problems of diseases that are endemic to India 3. SAE Events: Most of the participants in the trials are vulnerable and have no access to medical facilities and social safety nets. Registration of deaths due to drug use has been covered up and these are classified as unnatural but normal deaths, making the company not liable for any compensation 4. PATH case of HPV: PATH in order to make the process speedy has registered the HPV trial as observational and not a trial as such, CDSCO and ICMR have collaborated with them in this and this is a cause of concern.
DGCI has stated the collusion of CDSCO and ICMR in the PATH case as a really disturbing phenomenon.
The newer policy needs to address the following things;
1. better monitoring of the trials and stringent procedures for approval of trials 2. More importance should be placed on testing drugs that are helpful for India 3. Better safety nets and awareness among volunteers about the programme and the possibilities.
With this in context, There is definitely a need of a newer and stringent clinical trial policy which does not deter innovation and testing but regulated it better safeguarding the lives of the people who volunteer as test subjects as well as develops newer drugs for the diseases prevalent in India.
2. There is no provision for restriction of sales of arms to terrorists and non-state actors 3. gifts and sales to non-state actors and terrorists need to be controlled or banned as it leads to regional security issues 2. Non-state actors threaten its internal security
I got the impression that you are repeating the same basic point thrice. I am not sure that it's a good practice.
The third answer is perfect but again 346 words for a 15 marker. Just be careful with the word limit.
Govt. has introduced many poverty alleviation programmes for rural poor to address their chronic poverty like MGNREGA - Increased rural wages substantially and also helped in developing community assets NRLM - Support to rural entrepreneurship and improving skill sets and building income generating sources IAY - Build houses for BPL and APL SC/ST households TCS/NBA - Provide sanitation to all NRHM - Medical access to rural households
for every rural scheme mentioned above, there's an urban one - NULM, RAY, RAY, ILCS, NUHM and better employment opportunities, although unorganized, in urban areas counter the need for NREGA.
1. urban slum problem which is leading to ghettoisation - RAY,RRY were suppose to address the problem but the schemes have not been able to provide the desired results
RAY (2009) is much newer compared to IAY while RRY has just been relaunched under new name this year. Early days to evaluate.
2. Non-access to PDS being a non-local resident
Being migrants and not having legitimate house, they don't get PDS facilities and are aware of this before migration. In rural areas, they don't get even though deserve. Don't you think their conditions is worse?
2. Resource crunch - The explosion of population has led to water crunch, deterioration in living conditions and poor sanitation
Probably here with water, NRDWM could have been mentioned that doesn't have a counter in Urban.
Probably you could have focussed more on urban social issues that rural poor don't have to face, like you already have but in brief (ghettoization, social unrest, inequalities, urban crimes, pollution) rather than comparing schemes at the outset. Having said this, I myself, don't write anything better than this during exam. It's only during review that I've pointed these. So, no concerns.
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Comments
Anyways, mai sone chala.
@dp81 and @all my bros : Please sleep early guys or you will feel sleepy as I did during my morning tests at chronicle. Trust me, it will affect your performance !
Moreover There have been many deaths and serious adverse effects also directly related to clinical trials.
Present weaknesses:
informed consent document does not capture the full details of the subjects and in case of SAE they are left to fend for themselves
CDSCO is understaffed and as a result 1000s of application are cleared without due scrutiny.Clear conflict of interest whether it has to promote more clinical trials or to look into safety of the patients
Pharma companies usually gather the data and send it back to their home country
drugs for which the trials being held do not cover the commonly found diseases in India
In wake of these shortcomings a clinical trial policy is a must and following can be its salient provisions:
The informed consent process should be videotapped but confidentiality must be ensured
All the ethics committee and sponsor should be registered and in case of any SAE all the medical expenses should be borne by them until it is resolved
Drugs must only be approved if there is a clear case of public health benefits
Any departure from the stipulated norms should lead to the cancellation or revocation of license of the ethics committee/sponsor
In given scenario of heavy burden of disease in India clinical trials role cannot be underemphasized .A well-defined policy that harmonizes the interest of all stakeholders viz sponsor,ethics committee and patient will go a long way in easing it.
Ans- Yes I agree. As far as the conditions of poor people are concerned, the urban poor are definitely deplorable as compared to that of their rural counterparts. The reasons being-
(a) Government policies are more focussed toward rural poor than urban poor.
(b) The income gap & sociological differences are much wider in urban areas than rural areas.
(c) Rising pollution & reducing sanitation in poor dwellings & slums are a common feature of urban areas. It increases the chances of health hazards. Rural regions are comparatively pollution free.
(d) With rising commercialization in urban areas, the concern for poor people is much less in urban regions as compared to rural regions.
The socio-economic situation in India is very much affected by the rising urbanisation. It has numerous impacts which can be assessed as-
(a) Rising commercialization- Apart from increasing the gap between rich & poor, it is creating a sense of inferiority complex in the mind of deprived people. Moreover, it has given birth to a 'show-off' culture in major cities.
(b) Rising Industrialization- Rising demands of people has turned the focus on rapid & more production of goods & services. It is beneficial for the country & is acting as a growth engine. On the other hand, it is leading to pollution, waste management problems, creation of a new labour class, illegal minings, illegal land acquisition etc.
(c) Good standard of living- This factor is the outcome of previous two factors. Urbanisation has brought new avenues of employment, better facilities for health, education, communication, transport etc.
Overall, we can say that Rising Urbanisation is a coin with two sides of different shades. Proper planning & proactive steps by government can definitely improve the socio-economical status of India. Government has already took many steps in this direction like JNNURM, Anti pollution laws, Urban waste management & sewage treatment techniques etc & are most welcome.
Ans
Yes, Urban poor have been forced to live in more deplorable conditions than their rural counterparts due to lack of government attention and adequate safety nets.
Govt. has introduced many poverty alleviation programmes for rural poor to address their chronic poverty like
MGNREGA - Increased rural wages substantially and also helped in developing community assets
NRLM - Support to rural entrepreneurship and improving skill sets and bulding income generating sources
IAY - Build houses for BPL and APL SC/ST households
TCS/NBA - Provide sanitation to all
NRHM - Medical access to rural households
On the contrary govt. has been lethargic in addressing the urban issues
1. urban slum problem which is leading to ghettoisation - RAY,RRY were suppose to address the problem but the schemes have not been able to provide the desired results
2. Non-access to PDS being a non-local resident
3. High cost of living leading to alienation to basic amenities
4. Non-availability of medical facilities - Both in terms of accessibility and being priced out
If we look at the impact of urbanisation on socio-economic conditions, we can say it has led to:
1. Slums/Ghettoisation - High cost of land and housing and also unavailability of land has led to formation of slums
2. Resource crunch - The explosion of population has led to water crunch, deterioration in living conditions and poor sanitation
3. Increased Impoverishment - Migrant rural population are vulnerable and there are no safety nets, and the low wages with price rise and non-access to formal medical care leads to increased incidence of poverty
On the other hand, Urbanisation has created a strong middle class which has helped in increasing the growth prospects, a better governance system with transparency, a better standard of living for many people and most of all better education and medical facilities.
on the whole, we see that Rural-Urban migration and Urbanisation has its own pros and cons, but the pros outweigh the cons but we should be able to address the concerns of the migrant rural community by providing them with better safety nets, medical facilities which is now under NUHM and development of corridors under National Urbanisation Policy etc.
2. “A major vulnerability of India is the proliferation of illicit small arms and ammunitions manufactured overseas”.Despite this India and other nations abstained to sign the recent Arms Trade Treaty. Why? Comment on the validity of India’s stand and suggest measures to make ATT more conducive. 250W, 25M
Ans
Arms Trade Treaty (ATT) was signed by many countries this year. It is a good step to regulate the flow and sale of arms but the agreement had its own loopholes and concerns which prompted countries like India to abstain.
ATT has certain provision like:
1. The seller of the arms can unilaterally cancel the arms sale agreement.
2. There is no provision for restriction of sales of arms to terrorists and non-state actors
3. There were no restrictions on arms being given as gifts or loans
India has objected to all the 3 provisions stated above and vouched for a more balanced ATT. It wanted the following provisions,
1. While exporting, the end user need to be mentioned
2. Also, exporter should not be allowed to unilaterally cancel the sales agreement and there should some sort of arbitration or agreement between the parties
3. gifts and sales to non-state actors and terrorists need to be controlled or banned as it leads to regional security issues
The Western countries did not consider these proposals and India had to abstain to show its dissent and also India feels the agreement in its present form would be disadvantageous to her as
1. She is one of the biggest weapons importer
2. Non-state actors threaten its internal security
3. Examine the relevance of the clinical trials in India under the growing cases of misuse of the standard process of informed consent of the participants. 15M, 150W
Ans
Clinical trials are a necessity to understand the efficacy and the achievement of desired effect of the new vaccine/formulation which would lead to faster discoveries of newer drugs leading to eradication of many diseases in India.
India has hence implemented a very favorable and friendly clinical trial policy to achieve the same.
There have been many issues around clinical trials that are coming up and most of them are SAE (Severely Adverse Effect) cases which has concerned the relevant authorities.
Issues with clinical trials:
1. Consent of the individuals undergoing the trial is not taken and recorded properly
2. Most trials undertaken are for drugs to be uses in overseas markets and for measuring bioequivalence/efficacy of established drugs and not for newer drugs to address the problems of diseases that are endemic to India
3. SAE Events: Most of the participants in the trials are vulnerable and have no access to medical facilities and social safety nets. Registration of deaths due to drug use has been covered up and these are classified as unnatural but normal deaths, making the company not liable for any compensation
4. PATH case of HPV: PATH in order to make the process speedy has registered the HPV trial as observational and not a trial as such, CDSCO and ICMR have collaborated with them in this and this is a cause of concern.
DGCI has stated the collusion of CDSCO and ICMR in the PATH case as a really disturbing phenomenon.
The newer policy needs to address the following things;
1. better monitoring of the trials and stringent procedures for approval of trials
2. More importance should be placed on testing drugs that are helpful for India
3. Better safety nets and awareness among volunteers about the programme and the possibilities.
With this in context, There is definitely a need of a newer and stringent clinical trial policy which does not deter innovation and testing but regulated it better safeguarding the lives of the people who volunteer as test subjects as well as develops newer drugs for the diseases prevalent in India.
@Vivekanand @Oceanus @karan_004 @Siddharth @dp81 @Eric @deusAdeeb Rate my answers folks.
2. There is no provision for restriction of sales of arms to terrorists and non-state actors
3. gifts and sales to non-state actors and terrorists need to be controlled or banned as it leads to regional security issues
2. Non-state actors threaten its internal security
I got the impression that you are repeating the same basic point thrice. I am not sure that it's a good practice.
The third answer is perfect but again 346 words for a 15 marker. Just be careful with the word limit.
Govt. has introduced many poverty alleviation programmes for rural poor to address their chronic poverty like
MGNREGA - Increased rural wages substantially and also helped in developing community assets
NRLM - Support to rural entrepreneurship and improving skill sets and building income generating sources
IAY - Build houses for BPL and APL SC/ST households
TCS/NBA - Provide sanitation to all
NRHM - Medical access to rural households
for every rural scheme mentioned above, there's an urban one - NULM, RAY, RAY, ILCS, NUHM and better employment opportunities, although unorganized, in urban areas counter the need for NREGA.
1. urban slum problem which is leading to ghettoisation - RAY,RRY were suppose to address the problem but the schemes have not been able to provide the desired results
RAY (2009) is much newer compared to IAY while RRY has just been relaunched under new name this year. Early days to evaluate.
2. Non-access to PDS being a non-local resident
Being migrants and not having legitimate house, they don't get PDS facilities and are aware of this before migration. In rural areas, they don't get even though deserve. Don't you think their conditions is worse?
2. Resource crunch - The explosion of population has led to water crunch, deterioration in living conditions and poor sanitation
Probably here with water, NRDWM could have been mentioned that doesn't have a counter in Urban.
Probably you could have focussed more on urban social issues that rural poor don't have to face, like you already have but in brief (ghettoization, social unrest, inequalities, urban crimes, pollution) rather than comparing schemes at the outset. Having said this, I myself, don't write anything better than this during exam. It's only during review that I've pointed these. So, no concerns.