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Central drug controller puppet in hands of pharma giants
Pawan Kumar Bansal | 03 Oct 2013

Health and Family Welfare Ministry in its status report about CDSCO,submitted to Parliament Standing Committee on Health headed by Brajesh Pathak which has reviewed its functioning has stated that mission of CDSCO was to ''. meet the aspirations .....demands...and requirements of the pharmaceutical industry''

 In U.S.A mission of Food and Drugs Administration is 'protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs' whereas in United Kingdom mission of Health care Regulatory Authority is to enhance.

and safeguard the health of the public by ensuring that medicines and medical devices work and are acceptably safe.

This speaks itself that how our govt. and Health Regulatory agencies are puppet in hands of powerful Pharma lobby ignoring the interests of millions of poor patients. While observing that most of the ills besetting the system of drugs in India are mainly due to the skewed priorities and perception of CDSCO as for decades it has been according primacy to the propagation and facilitation of the drugs industry ignoring the interests of poor and helpless patients. Committee has asked the Health Ministry to change mission of CDSCO in very unambiguous terms that the organization is solely meant for public health.

With active support of Health Ministry and Drug Regulatory Authorities Pharma industry is growing with jet speed putting

 

 

Poor patients in the country having no choice but to purchase costly medicines thrown in market by Pharma giants.They manage licenses for manufacturing of even such drugs which

are banned in several developed countries and have no safety and efficacy. The C.S.D.O. which grants licenses for the manufacturing of new drugs is facing acute shortage of staff particularly the inspectors. It did not have any data of medical experts or penal of experts for making recommendations about the safety and efficacy of drugs.Pharma giants manages recommendations by influencing. the experts through unfair means and officials of C.S.D.O, grants licences by accepting the so called expert advise treating them as sermonsAof Bhgwat Gita.Pharma giants not only uses political clout but fill the pockets of concerned officials. It goes to the credit of B.S.P. member of Rajya Sabha Brijesh Pathak who in his capacity of Head of Parliament Standing Committee on Health has exposed this nexus. It is another thing that despite the recommendations of the Committee for taking action against concerned officials the Health Ministry is silent on the sensitive issue affecting the millions of poor patients. the committee has also pointed towards shortage of inspectors. Thanking the Committee for highlighting the issue ,Prof.Balasubranium, former President of Indian Pharmacy Graduates Association has demanded that unemployed Pharma graduate and post graduates should be appointed on these posts adding that Governments apathy and influence of vested interests if responsible for this state of affairs.

 

Standing committee had spotted irregularities in the operations of the Central Drugs Standard Control Organization. Turns out the CDSCO is facing a severe staff shortage and the headquarters is staffed by four deputy and five assistant drug controllers. These nine officers alone handle 20,000 applications, over 200 meetings, attend to 11,000 public/industry representatives, respond to 700 Parliament questions and around 150 court cases annually.

.

The report says,“If the manpower requirement of the CDSCO does not correspond with their volume of work, naturally, such shortage of staff strains the ability of the CDSCO to discharge its assigned functions efficiently. This shortcoming needs to be addressed quickly. Consideration can also be given to employ medically qualified persons as consultants/advisers at suitable rank.”

The Union Health secretary has informed the committee that this serious supply and demand situation was created due to the fact that medical professionals don’ want to join the CDSCO. “Though recruitment rules provide for appointing people with MBBS degree or/with pharmacology, microbiology, usually, there was no response from persons from these fields.”

IT did not have permanent penal of medical experts attached with it..Although two expert committees namely investigational New Drug Committee and cellular Biology-based Therapeutic Drug Evaluation Committee has been set up for advising the Drug Controller General of India..Apart from experts from subject specialists are identified from time to time amongst the medical specialists from institutes like P.G.I.Chandigarh,AIIMS,I.C.M.R as well as individual practicing doctors for their expert opinion.

 

Parliament Standing Committee on Ministry of Health and Family Welfare headed by B.S.P. member of Rajyasbha .Brajesh Pathak has thirteen members from upper house and 14 from Loksabha cutting across party lines. Committee deserves kudos for exposing the Pharma lobby

, doctors and officials of CDSO nexus resulting into loot of poor and helpless patients However it is astonishing that despite having powerful members like Janardhandiwedi and Jyoti Mirdha its recommendations are not taken seriously by the Ministry .Brajesh Pathak, chairman of the committee it may be recalled has stalled the move of Health Minister Gulam Nabi Azad for removal of Sanjiv Chaturvedi .C.V.C of AIIMS.The Committee has exposed the role of Indian Council of Medical Research, Drug Controller General of India and Health Ministry in allowing clinical trials for drugs to the N.G.O. of Bill Clinton without necessary formalities which has resulted in death of six tribal girls..The committee has recommended stern action against responsible persons.

 

 

 

 

 

 

 

 

 

 




 

Health and Family Welfare Ministry in its status report about CDSCO,submitted to Parliament Standing Committee on Health headed by Brajesh Pathak which has reviewed its functioning has stated that mission of CDSCO was to ''. meet the aspirations .....demands...and requirements of the pharmaceutical industry'' In U.S..A mission of Food and Drugs Administration is 'protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs' whereas in United Kingdom mission of Health care Regulatory Authority is to enhance.

and safeguard the health of the public by ensuring that medicines and medical devices work and are acceptably safe.

This speaks itself that how our govt. and Health Regulatory agencies are puppet in hands of powerful Pharma lobby ignoring the interests of millions of poor patients. While observing that most of the ills besetting the system of drugs in India are mainly due to the skewed priorities and perception of CDSCO as for decades it has been according primacy to the propagation and facilitation of the drugs industry ignoring the interests of poor and helpless patients. Committee has asked the Health Ministry to change mission of CDSCO in very unambiguous terms that the organization is solely meant for public health.

With active support of Health Ministry and Drug Regulatory Authorities Pharma industry is growing with jet speed putting

 

 

Poor patients in the country having no choice but to purchase costly medicines thrown in market by Pharma giants.They manage licenses for manufacturing of even such drugs which

are banned in several developed countries and have no safety and efficacy. The C.S.D.O. which grants licenses for the manufacturing of new drugs is facing acute shortage of staff particularly the inspectors. It did not have any data of medical experts or penal of experts for making recommendations about the safety and efficacy of drugs.Pharma giants manages recommendations by influencing. the experts through unfair means and officials of C.S.D.O, grants licences by accepting the so called expert advise treating them as sermonsAof Bhgwat Gita.Pharma giants not only uses political clout but fill the pockets of concerned officials. It goes to the credit of B.S.P. member of Rajya Sabha Brijesh Pathak who in his capacity of Head of Parliament Standing Committee on Health has exposed this nexus. It is another thing that despite the recommendations of the Committee for taking action against concerned officials the Health Ministry is silent on the sensitive issue affecting the millions of poor patients. the committee has also pointed towards shortage of inspectors. Thanking the Committee for highlighting the issue ,Prof.Balasubranium, former President of Indian Pharmacy Graduates Association has demanded that unemployed Pharma graduate and post graduates should be appointed on these posts adding that Governments apathy and influence of vested interests if responsible for this state of affairs.

 

Standing committee had spotted irregularities in the operations of the Central Drugs Standard Control Organization. Turns out the CDSCO is facing a severe staff shortage and the headquarters is staffed by four deputy and five assistant drug controllers. These nine officers alone handle 20,000 applications, over 200 meetings, attend to 11,000 public/industry representatives, respond to 700 Parliament questions and around 150 court cases annually.

.

The report says,“If the manpower requirement of the CDSCO does not correspond with their volume of work, naturally, such shortage of staff strains the ability of the CDSCO to discharge its assigned functions efficiently. This shortcoming needs to be addressed quickly. Consideration can also be given to employ medically qualified persons as consultants/advisers at suitable rank.”

The Union Health secretary has informed the committee that this serious supply and demand situation was created due to the fact that medical professionals don’ want to join the CDSCO. “Though recruitment rules provide for appointing people with MBBS degree or/with pharmacology, microbiology, usually, there was no response from persons from these fields.”

IT did not have permanent penal of medical experts attached with it..Although two expert committees namely investigational New Drug Committee and cellular Biology-based Therapeutic Drug Evaluation Committee has been set up for advising the Drug Controller General of India..Apart from experts from subject specialists are identified from time to time amongst the medical specialists from institutes like P.G.I.Chandigarh,AIIMS,I.C.M.R as well as individual practicing doctors for their expert opinion.

 

Parliament Standing Committee on Ministry of Health and Family Welfare headed by B.S.P. member of Rajyasbha .Brajesh Pathak has thirteen members from upper house and 14 from Loksabha cutting across party lines. Committee deserves kudos for exposing the Pharma lobby

, doctors and officials of CDSO nexus resulting into loot of poor and helpless patients However it is astonishing that despite having powerful members like Janardhandiwedi and Jyoti Mirdha its recommendations are not taken seriously by the Ministry .Brajesh Pathak, chairman of the committee it may be recalled has stalled the move of Health Minister Gulam Nabi Azad for removal of Sanjiv Chaturvedi .C.V.C of AIIMS.The Committee has exposed the role of Indian Council of Medical Research, Drug Controller General of India and Health Ministry in allowing clinical trials for drugs to the N.G.O. of Bill Clinton without necessary formalities which has resulted in death of six tribal girls..The committee has recommended stern action against responsible persons.

 

 

 

 

 

 

 

 

 

 




 

Health and Family Welfare Ministry in its status report about CDSCO,submitted to Parliament Standing Committee on Health headed by Brajesh Pathak which has reviewed its functioning has stated that mission of CDSCO was to ''. meet the aspirations .....demands...and requirements of the pharmaceutical industry'' In U.S..A mission of Food and Drugs Administration is 'protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs' whereas in United Kingdom mission of Health care Regulatory Authority is to enhance.

and safeguard the health of the public by ensuring that medicines and medical devices work and are acceptably safe.

This speaks itself that how our govt. and Health Regulatory agencies are puppet in hands of powerful Pharma lobby ignoring the interests of millions of poor patients. While observing that most of the ills besetting the system of drugs in India are mainly due to the skewed priorities and perception of CDSCO as for decades it has been according primacy to the propagation and facilitation of the drugs industry ignoring the interests of poor and helpless patients. Committee has asked the Health Ministry to change mission of CDSCO in very unambiguous terms that the organization is solely meant for public health.

With active support of Health Ministry and Drug Regulatory Authorities Pharma industry is growing with jet speed putting

 

 

Poor patients in the country having no choice but to purchase costly medicines thrown in market by Pharma giants.They manage licenses for manufacturing of even such drugs which

are banned in several developed countries and have no safety and efficacy. The C.S.D.O. which grants licenses for the manufacturing of new drugs is facing acute shortage of staff particularly the inspectors. It did not have any data of medical experts or penal of experts for making recommendations about the safety and efficacy of drugs.Pharma giants manages recommendations by influencing. the experts through unfair means and officials of C.S.D.O, grants licences by accepting the so called expert advise treating them as sermonsAof Bhgwat Gita.Pharma giants not only uses political clout but fill the pockets of concerned officials. It goes to the credit of B.S.P. member of Rajya Sabha Brijesh Pathak who in his capacity of Head of Parliament Standing Committee on Health has exposed this nexus. It is another thing that despite the recommendations of the Committee for taking action against concerned officials the Health Ministry is silent on the sensitive issue affecting the millions of poor patients. the committee has also pointed towards shortage of inspectors. Thanking the Committee for highlighting the issue ,Prof.Balasubranium, former President of Indian Pharmacy Graduates Association has demanded that unemployed Pharma graduate and post graduates should be appointed on these posts adding that Governments apathy and influence of vested interests if responsible for this state of affairs.

 

Standing committee had spotted irregularities in the operations of the Central Drugs Standard Control Organization. Turns out the CDSCO is facing a severe staff shortage and the headquarters is staffed by four deputy and five assistant drug controllers. These nine officers alone handle 20,000 applications, over 200 meetings, attend to 11,000 public/industry representatives, respond to 700 Parliament questions and around 150 court cases annually.

.

The report says,“If the manpower requirement of the CDSCO does not correspond with their volume of work, naturally, such shortage of staff strains the ability of the CDSCO to discharge its assigned functions efficiently. This shortcoming needs to be addressed quickly. Consideration can also be given to employ medically qualified persons as consultants/advisers at suitable rank.”

The Union Health secretary has informed the committee that this serious supply and demand situation was created due to the fact that medical professionals don’ want to join the CDSCO. “Though recruitment rules provide for appointing people with MBBS degree or/with pharmacology, microbiology, usually, there was no response from persons from these fields.”

IT did not have permanent penal of medical experts attached with it..Although two expert committees namely investigational New Drug Committee and cellular Biology-based Therapeutic Drug Evaluation Committee has been set up for advising the Drug Controller General of India..Apart from experts from subject specialists are identified from time to time amongst the medical specialists from institutes like P.G.I.Chandigarh,AIIMS,I.C.M.R as well as individual practicing doctors for their expert opinion.

 

Parliament Standing Committee on Ministry of Health and Family Welfare headed by B.S.P. member of Rajyasbha .Brajesh Pathak has thirteen members from upper house and 14 from Loksabha cutting across party lines. Committee deserves kudos for exposing the Pharma lobby

, doctors and officials of CDSO nexus resulting into loot of poor and helpless patients However it is astonishing that despite having powerful members like Janardhandiwedi and Jyoti Mirdha its recommendations are not taken seriously by the Ministry .Brajesh Pathak, chairman of the committee it may be recalled has stalled the move of Health Minister Gulam Nabi Azad for removal of Sanjiv Chaturvedi .C.V.C of AIIMS.The Committee has exposed the role of Indian Council of Medical Research, Drug Controller General of India and Health Ministry in allowing clinical trials for drugs to the N.G.O. of Bill Clinton without necessary formalities which has resulted in death of six tribal girls..The committee has recommended stern action against responsible persons.

 

 

 

 

 

 

 

 

 

 




 

Health and Family Welfare Ministry in its status report about CDSCO,submitted to Parliament Standing Committee on Health headed by Brajesh Pathak which has reviewed its functioning has stated that mission of CDSCO was to ''. meet the aspirations .....demands...and requirements of the pharmaceutical industry'' In U.S..A mission of Food and Drugs Administration is 'protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs' whereas in United Kingdom mission of Health care Regulatory Authority is to enhance.

and safeguard the health of the public by ensuring that medicines and medical devices work and are acceptably safe.

This speaks itself that how our govt. and Health Regulatory agencies are puppet in hands of powerful Pharma lobby ignoring the interests of millions of poor patients. While observing that most of the ills besetting the system of drugs in India are mainly due to the skewed priorities and perception of CDSCO as for decades it has been according primacy to the propagation and facilitation of the drugs industry ignoring the interests of poor and helpless patients. Committee has asked the Health Ministry to change mission of CDSCO in very unambiguous terms that the organization is solely meant for public health.

With active support of Health Ministry and Drug Regulatory Authorities Pharma industry is growing with jet speed putting

 

 

Poor patients in the country having no choice but to purchase costly medicines thrown in market by Pharma giants.They manage licenses for manufacturing of even such drugs which

are banned in several developed countries and have no safety and efficacy. The C.S.D.O. which grants licenses for the manufacturing of new drugs is facing acute shortage of staff particularly the inspectors. It did not have any data of medical experts or penal of experts for making recommendations about the safety and efficacy of drugs.Pharma giants manages recommendations by influencing. the experts through unfair means and officials of C.S.D.O, grants licences by accepting the so called expert advise treating them as sermonsAof Bhgwat Gita.Pharma giants not only uses political clout but fill the pockets of concerned officials. It goes to the credit of B.S.P. member of Rajya Sabha Brijesh Pathak who in his capacity of Head of Parliament Standing Committee on Health has exposed this nexus. It is another thing that despite the recommendations of the Committee for taking action against concerned officials the Health Ministry is silent on the sensitive issue affecting the millions of poor patients. the committee has also pointed towards shortage of inspectors. Thanking the Committee for highlighting the issue ,Prof.Balasubranium, former President of Indian Pharmacy Graduates Association has demanded that unemployed Pharma graduate and post graduates should be appointed on these posts adding that Governments apathy and influence of vested interests if responsible for this state of affairs.

 

Standing committee had spotted irregularities in the operations of the Central Drugs Standard Control Organization. Turns out the CDSCO is facing a severe staff shortage and the headquarters is staffed by four deputy and five assistant drug controllers. These nine officers alone handle 20,000 applications, over 200 meetings, attend to 11,000 public/industry representatives, respond to 700 Parliament questions and around 150 court cases annually.

.

The report says,“If the manpower requirement of the CDSCO does not correspond with their volume of work, naturally, such shortage of staff strains the ability of the CDSCO to discharge its assigned functions efficiently. This shortcoming needs to be addressed quickly. Consideration can also be given to employ medically qualified persons as consultants/advisers at suitable rank.”

The Union Health secretary has informed the committee that this serious supply and demand situation was created due to the fact that medical professionals don’ want to join the CDSCO. “Though recruitment rules provide for appointing people with MBBS degree or/with pharmacology, microbiology, usually, there was no response from persons from these fields.”

IT did not have permanent penal of medical experts attached with it..Although two expert committees namely investigational New Drug Committee and cellular Biology-based Therapeutic Drug Evaluation Committee has been set up for advising the Drug Controller General of India..Apart from experts from subject specialists are identified from time to time amongst the medical specialists from institutes like P.G.I.Chandigarh,AIIMS,I.C.M.R as well as individual practicing doctors for their expert opinion.

 

Parliament Standing Committee on Ministry of Health and Family Welfare headed by B.S.P. member of Rajyasbha .Brajesh Pathak has thirteen members from upper house and 14 from Loksabha cutting across party lines. Committee deserves kudos for exposing the Pharma lobby

, doctors and officials of CDSO nexus resulting into loot of poor and helpless patients However it is astonishing that despite having powerful members like Janardhandiwedi and Jyoti Mirdha its recommendations are not taken seriously by the Ministry .Brajesh Pathak, chairman of the committee it may be recalled has stalled the move of Health Minister Gulam Nabi Azad for removal of Sanjiv Chaturvedi .C.V.C of AIIMS.The Committee has exposed the role of Indian Council of Medical Research, Drug Controller General of India and Health Ministry in allowing clinical trials for drugs to the N.G.O. of Bill Clinton without necessary formalities which has resulted in death of six tribal girls..The committee has recommended stern action against responsible persons.