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Hi NetRUMians,I could not resist from sharing what I had seen during my research on the National Pharmacovigilance Programme.Some Major Points on ADRs in U-5 Children:1. The ADRs in the under-5 age group children contributed to 225 [

3.7percent] ADR reports.2. The anti-microbial drugs wereresponsible for majority of ADRs [116 (51.6percent)] followed by the drugs acting on thecentral nervous system [28(12.4percent)] and the vaccines/sera [23(

10.2)].3. Skin was the most commonly involved system [104 cases (46.4percent)] followed bythe Central Nervous System [36 cases (16.1percent)] and the Gastro-Intestinal Tract [35cases (15.6percent)]4. 5[2.6percent

] ADRs resulted in the death of the child, 75[38.9percent] ADRs resulted inhospitalization (initial/prolonged) and 4[2.1percent] had a life threatening complication and13[6.7percent] children required intervention to prevent permanent impairment/damage.

5. Vaccines and ADRs21[36.8percent] ADRs resulted in hospitalization. These were due to DPT/HBV/OPV6. ADRs in the children and the elderly(60+) constitute to less than 12% of the overall ADR reports when one can expect ADRs most commonly in these age-groups due to the increased susceptibility.

Sincerely,Dr.Manoj SwaminathanPharmacovigilance PhysicianSciformix Technologies (P) Ltd.

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Hello Sir, It is nice to see your spontaneous contribution to the discussion and that to the result of your research works on NPP. This enriches our discussion with more evident data. Antimicrobial agents contribute to 50% of total ADRs. This increases responsibility of prescribers to advice parents

accordingly, more work regarding formulations, strength of drug, dosing schedule of the drug and standard guidelines regarding treatment. Simplest instruction regarding the reconstitution of the antimicrobial medicines provided as suspension like use of atleast potable water if not sterile water, shake medication well before use, and use the medication within one month once formulated might help in reduction in associated ADRs. CNS system takes 2nd rank in both as system involved in ADRs and as category of medicines causing ADR. Considering the paramount importance of developmental changes taking place during paediatric age, thorough pre and post marketing ADR reporting is must in this

area. ADR related to the vaccines is also a crucial but not so much investigated area till date. Basically there are many misconceptions regarding vaccines. Pharmacovigilance in area of vaccine has to be paid much attention. Please Sir, help me out to understand the last finding. Does this mean that the hype is made or expectations are high regarding high incidence of ADR in the extreme age group population but the findings do

not correlate with the same? If it is so what could be the reasons for the same? Corrections are awaited. Regards, Dr Smita,GMC, Nagpur. "Dr.Manoj Swaminathan" <drmanoj@...> wrote: Hi NetRUMians,I could not resist from sharing what I had seen during my research on the National Pharmacovigilance Programme.Some Major Points on ADRs in U-5 Children:1. The ADRs in the under-5 age group children contributed

to 225 [ 3.7percent] ADR reports.2. The anti-microbial drugs wereresponsible for majority of ADRs [116 (51.6percent)] followed by the drugs acting on thecentral nervous system [28(12.4percent)] and the vaccines/sera [23( 10.2)].3. Skin was the most commonly involved system [104 cases (46.4percent)] followed bythe Central Nervous System [36 cases (16.1percent)] and the Gastro-Intestinal Tract [35cases (15.6percent)]4. 5[2.6percent ] ADRs resulted in the death of the child, 75[38.9percent] ADRs resulted inhospitalization (initial/prolonged) and 4[2.1percent] had a life threatening complication and13[6.7percent] children required intervention to prevent permanent impairment/damage. 5. Vaccines and ADRs21[36.8percent] ADRs resulted in hospitalization. These were due to DPT/HBV/OPV6. ADRs in the children and the elderly(60+) constitute to less than 12% of the overall ADR reports when one can

expect ADRs most commonly in these age-groups due to the increased susceptibility. Sincerely,Dr.Manoj SwaminathanPharmacovigilance PhysicianSciformix Technologies (P) Ltd.

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Hi Smita,Yes. The expectations are high as regards to the number of ADRs reported in the extreme age-groups. It seems that there is a bias towards reporting more ADRs among the middle age-groups.I am sure that many netRUMians wont agree with my views. Looking at the high morbidity patterns in the extreme age-groups, exposure to different kinds of drugs and increased susceptibility due to their body textures, one should expect more ADRs in the extreme age-groups.

One more thing - It is necessary to look at the ADRs among the HIV affected children who are on the Anti-retrovirals.I dont know whether pediatric ARV formulations are available on a large scale but I remember one year ago during my visit (as a part of the WHO-PRUDC course at Jaipur) when we came across HIV-affected people.

There was a family where the father and mother were taking 1 tablet of AZT and their 6-month child was given a Quarter tablet.I am not sure whether " Pediatric formulation " is available in the freely supplied ARVs..

Sincerely,Dr.Manoj SwaminathanPharmacovigilance PhysicianSciformix Technologies (P) Ltd.On Nov 25, 2007 8:26 PM, smita mali <

smt_mali@...> wrote:

Hello Sir,

It is nice to see your spontaneous contribution to the discussion and that to the result of your research works on NPP. This enriches our discussion with more evident data.

Antimicrobial agents contribute to 50% of total ADRs. This increases responsibility of prescribers to advice parents

accordingly, more work regarding formulations, strength of drug, dosing schedule of the drug and standard guidelines regarding treatment. Simplest instruction regarding the reconstitution of the antimicrobial medicines provided as suspension like use of atleast potable water if not sterile water, shake medication well before use, and use the medication within one month once formulated might help in reduction in associated ADRs.

CNS system takes 2nd rank in both as system involved in ADRs and as category of medicines causing ADR. Considering the paramount importance of developmental changes taking place during paediatric age, thorough pre and post marketing ADR reporting is must in this

area. ADR related to the vaccines is also a crucial but not so much investigated area till date. Basically there are many misconceptions regarding vaccines. Pharmacovigilance in area of vaccine has to be paid much attention.

Please Sir, help me out to understand the last finding. Does this mean that the hype is made or expectations are high regarding high incidence of ADR in the extreme age group population but the findings do

not correlate with the same? If it is so what could be the reasons for the same?

Corrections are awaited.

Regards, Dr Smita,GMC, Nagpur. "

Dr.Manoj Swaminathan " <drmanoj@...> wrote: Hi NetRUMians,

I could not resist from sharing what I had seen during my research on the National Pharmacovigilance Programme.Some Major Points on ADRs in U-5 Children:1. The ADRs in the under-5 age group children contributed

to 225 [ 3.7percent] ADR reports.2. The anti-microbial drugs wereresponsible for majority of ADRs [116 (51.6percent)] followed by the drugs acting on thecentral nervous system [28(12.4percent)] and the vaccines/sera [23( 10.2)].3. Skin was the most commonly involved system [104 cases (46.4percent)] followed bythe Central Nervous System [36 cases (16.1percent)] and the Gastro-Intestinal Tract [35cases (15.6percent)]4. 5[2.6percent

] ADRs resulted in the death of the child, 75[38.9percent] ADRs resulted inhospitalization (initial/prolonged) and 4[2.1percent] had a life threatening complication and13[6.7percent] children required intervention to prevent permanent impairment/damage. 5. Vaccines and ADRs21[36.8percent] ADRs resulted in hospitalization. These were due to DPT/HBV/OPV6. ADRs in the children and the elderly(60+) constitute to less than 12% of the overall ADR reports when one can

expect ADRs most commonly in these age-groups due to the increased susceptibility. Sincerely,Dr.Manoj SwaminathanPharmacovigilance PhysicianSciformix Technologies (P) Ltd.

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Hi,

ADRs are more in extremes of age. Reporting is less so the figures

make it look that ADRs are less. Actually it is not so. Am I right

Manoj?

Vijay

Hi

NetRUMians,

>

> I could not resist from sharing what I had seen during my research

on the National Pharmacovigilance Programme.

>

> Some Major Points on ADRs in U-5 Children:

> 1. The ADRs in the under-5 age group children contributed to 225 [

3.7percent] ADR reports.

> 2. The anti-microbial drugs were

> responsible for majority of ADRs [116 (51.6percent)] followed by

the drugs acting on the

> central nervous system [28(12.4percent)] and the vaccines/sera [23

( 10.2)].

> 3. Skin was the most commonly involved system [104 cases

(46.4percent)] followed by

> the Central Nervous System [36 cases (16.1percent)] and the Gastro-

Intestinal Tract [35

> cases (15.6percent)]

> 4. 5[2.6percent ] ADRs resulted in the death of the child, 75

[38.9percent] ADRs resulted in

> hospitalization (initial/prolonged) and 4[2.1percent] had a life

threatening complication and

> 13[6.7percent] children required intervention to prevent permanent

impairment/damage.

>

> 5. Vaccines and ADRs

> 21[36.8percent] ADRs resulted in hospitalization. These were due

to DPT/HBV/OPV

>

> 6. ADRs in the children and the elderly(60+) constitute to less

than 12% of the overall ADR reports when one can expect ADRs most

commonly in these age-groups due to the increased susceptibility.

>

> Sincerely,

> Dr.Manoj Swaminathan

> Pharmacovigilance Physician

> Sciformix Technologies (P) Ltd.

>

>

>

>

>

>

>

>

> ---------------------------------

> Chat on a cool, new interface. No download required. Click here.

>

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Hi Vijay Sir,

Yes. The figures make it look that the ADRs are less among the extreme age-groups...due to low reporting in these age groups.

Manoj

On 11/26/07, Vijay <drvijaythawani@...> wrote:

Hi,ADRs are more in extremes of age. Reporting is less so the figures make it look that ADRs are less. Actually it is not so. Am I right Manoj?Vijay Hi NetRUMians,> > I could not resist from sharing what I had seen during my research on the National Pharmacovigilance Programme.> > Some Major Points on ADRs in U-5 Children:

> 1. The ADRs in the under-5 age group children contributed to 225 [ 3.7percent] ADR reports.> 2. The anti-microbial drugs were> responsible for majority of ADRs [116 (51.6percent)] followed by

the drugs acting on the> central nervous system [28(12.4percent)] and the vaccines/sera [23( 10.2)].> 3. Skin was the most commonly involved system [104 cases (46.4percent)] followed by> the Central Nervous System [36 cases (

16.1percent)] and the Gastro-Intestinal Tract [35> cases (15.6percent)]> 4. 5[2.6percent ] ADRs resulted in the death of the child, 75[38.9percent] ADRs resulted in> hospitalization (initial/prolonged) and 4[

2.1percent] had a life threatening complication and> 13[6.7percent] children required intervention to prevent permanent impairment/damage. > > 5. Vaccines and ADRs> 21[36.8percent] ADRs resulted in hospitalization. These were due to DPT/HBV/OPV> > 6. ADRs in the children and the elderly(60+) constitute to less than 12% of the overall ADR reports when one can expect ADRs most commonly in these age-groups due to the increased susceptibility. > > Sincerely,> Dr.Manoj Swaminathan> Pharmacovigilance Physician> Sciformix Technologies (P) Ltd.> > > > > > > > > ---------------------------------

> Chat on a cool, new interface. No download required. Click here.>

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Hi Manoj,

Thanks for the instant response.

Concern appreciated.

Vijay

Hi

> > NetRUMians,

> > >

> > > I could not resist from sharing what I had seen during my

research

> > on the National Pharmacovigilance Programme.

> > >

> > > Some Major Points on ADRs in U-5 Children:

> > > 1. The ADRs in the under-5 age group children contributed to

225 [

> > 3.7percent] ADR reports.

> > > 2. The anti-microbial drugs were

> > > responsible for majority of ADRs [116 (51.6percent)] followed

by

> > the drugs acting on the

> > > central nervous system [28(12.4percent)] and the vaccines/sera

[23

> > ( 10.2)].

> > > 3. Skin was the most commonly involved system [104 cases

> > (46.4percent)] followed by

> > > the Central Nervous System [36 cases (16.1percent)] and the

Gastro-

> > Intestinal Tract [35

> > > cases (15.6percent)]

> > > 4. 5[2.6percent ] ADRs resulted in the death of the child, 75

> > [38.9percent] ADRs resulted in

> > > hospitalization (initial/prolonged) and 4[2.1percent] had a

life

> > threatening complication and

> > > 13[6.7percent] children required intervention to prevent

permanent

> > impairment/damage.

> > >

> > > 5. Vaccines and ADRs

> > > 21[36.8percent] ADRs resulted in hospitalization. These were

due

> > to DPT/HBV/OPV

> > >

> > > 6. ADRs in the children and the elderly(60+) constitute to less

> > than 12% of the overall ADR reports when one can expect ADRs most

> > commonly in these age-groups due to the increased susceptibility.

> > >

> > > Sincerely,

> > > Dr.Manoj Swaminathan

> > > Pharmacovigilance Physician

> > > Sciformix Technologies (P) Ltd.

> > >

> > >

> > >

> > >

> > >

> > >

> > >

> > >

> > > ---------------------------------

> > > Chat on a cool, new interface. No download required. Click

here.

> > >

> >

> >

> >

>

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Dear Dr. Manoj

Evidence shows that the number of HIV-affected children is on the rise but a lack of proper documentation is an impediment to addressing the needs of these children. In many parts of India, there is a growing awareness of the needs of children affected by HIV but there is a lack of commitment and coordination from government agencies.

While making notes on ARV Drugs for a symposium on WAD 2007 here at Aligarh, I noticed that the existing antiretroviral (ARV) treatment centres (ART Centres) are not child friendly. There is no arrangement of "ARV Paediatric Formulation". Many of these centers may not even be able to avoid children dropping out of support programmes. There are no policies or guidelines for working with children on this issue, let alone the necessary studies to inform the work. The responsibility for management of this crisis should be shared between the private and public sectors, but primarily the government should be made accountable. The nongovernmental organizations (NGOs) working in this sector are doing commendable work in their efforts of offer support services to children, despite the lack of support from the public sector. NGOs have been putting pressure on States AIDS Control Society and the relevant government departments to conduct situational analyses and a comprehensive study to find out the exact number of HIV-affected children in India but they remain unresponsive. Comprehensive child oriented programmes urgently need to be put in place. Addressing the needs of children living with and affected by HIV should be considered an international priority. But ironically, the World is not doing enough to address the needs of these children. Even the Joint United Nations Programme on HIV/AIDS (UNAIDS) doesn’t have the worldwide data they need to effectively address this crisis. The need of the hour is to strengthen political commitments both locally and globally to the welfare of children affected by HIV and to raise this issue at the next review meeting of the United Nations General Assembly Special Session on HIV/AIDS (UNGASS) in New York in 2008. The healthy development of children benefits all of society by providing a solid foundation for economic productivity, responsible citizenship, strong communities and a secure nation.

S. Ziaur Rahman, Aligarh

PS: Sorry to Dr. Smita for not posting any of my view earlier. I really did not follow any of the postings related to 'Safe medicines for children' under your able moderatorship as I was busy in arrangements of SoPI Conference at Jaipur.

Re: ADRs in Children

Hi Smita,Yes. The expectations are high as regards to the number of ADRs reported in the extreme age-groups. It seems that there is a bias towards reporting more ADRs among the middle age-groups.I am sure that many netRUMians wont agree with my views. Looking at the high morbidity patterns in the extreme age-groups, exposure to different kinds of drugs and increased susceptibility due to their body textures, one should expect more ADRs in the extreme age-groups. One more thing - It is necessary to look at the ADRs among the HIV affected children who are on the Anti-retrovirals.I dont know whether pediatric ARV formulations are available on a large scale but I remember one year ago during my visit (as a part of the WHO-PRUDC course at Jaipur) when we came across HIV-affected people. There was a family where the father and mother were taking 1 tablet of AZT and their 6-month child was given a Quarter tablet.I am not sure whether "Pediatric formulation" is available in the freely supplied ARVs.. Sincerely,Dr.Manoj SwaminathanPharmacovigilance PhysicianSciformix Technologies (P) Ltd.

On Nov 25, 2007 8:26 PM, smita mali < smt_mali (DOT) co.in> wrote:

Hello Sir,

It is nice to see your spontaneous contribution to the discussion and that to the result of your research works on NPP. This enriches our discussion with more evident data.

Antimicrobial agents contribute to 50% of total ADRs. This increases responsibility of prescribers to advice parents accordingly, more work regarding formulations, strength of drug, dosing schedule of the drug and standard guidelines regarding treatment. Simplest instruction regarding the reconstitution of the antimicrobial medicines provided as suspension like use of atleast potable water if not sterile water, shake medication well before use, and use the medication within one month once formulated might help in reduction in associated ADRs.

CNS system takes 2nd rank in both as system involved in ADRs and as category of medicines causing ADR. Considering the paramount importance of developmental changes taking place during paediatric age, thorough pre and post marketing ADR reporting is must in this area.

ADR related to the vaccines is also a crucial but not so much investigated area till date. Basically there are many misconceptions regarding vaccines. Pharmacovigilance in area of vaccine has to be paid much attention.

Please Sir, help me out to understand the last finding. Does this mean that the hype is made or expectations are high regarding high incidence of ADR in the extreme age group population but the findings do not correlate with the same?

If it is so what could be the reasons for the same?

Corrections are awaited.

Regards,

Dr Smita,GMC, Nagpur.

" Dr.Manoj Swaminathan" <drmanojgmail> wrote:

Hi NetRUMians,I could not resist from sharing what I had seen during my research on the National Pharmacovigilance Programme.Some Major Points on ADRs in U-5 Children:1. The ADRs in the under-5 age group children contributed to 225 [ 3.7percent] ADR reports.2. The anti-microbial drugs wereresponsible for majority of ADRs [116 (51.6percent)] followed by the drugs acting on thecentral nervous system [28(12.4percent)] and the vaccines/sera [23( 10.2)].3. Skin was the most commonly involved system [104 cases (46.4percent)] followed bythe Central Nervous System [36 cases (16.1percent)] and the Gastro-Intestinal Tract [35cases (15.6percent)]4. 5[2.6percent ] ADRs resulted in the death of the child, 75[38.9percent] ADRs resulted inhospitalization (initial/prolonged) and 4[2.1percent] had a life threatening complication and13[6.7percent] children required intervention to prevent permanent impairment/damage. 5. Vaccines and ADRs21[36.8percent] ADRs resulted in hospitalization. These were due to DPT/HBV/OPV6. ADRs in the children and the elderly(60+) constitute to less than 12% of the overall ADR reports when one can expect ADRs most commonly in these age-groups due to the increased susceptibility. Sincerely,Dr.Manoj SwaminathanPharmacovigilance PhysicianSciformix Technologies (P) Ltd.

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Hello Sir,

Though late because of your involvement in SOPI, we got the most

recent information regarding inumerable hurdles between safe

medicines and children especially in case of ARV treatment which is

need of an hour. This is truely a plus point of discussion.

Definitely the political commitment is must for implementation of

safe medicines for children.

Sorry Sir, as discussion was just an hour away from concluding time

limit I posted the summary before reply to your post.

Regards,

Dr Smita,

GMC, Nagpur.

> Hi NetRUMians,

>

> I could not resist from sharing what I had seen during my

research on the National Pharmacovigilance Programme.

>

> Some Major Points on ADRs in U-5 Children:

> 1. The ADRs in the under-5 age group children contributed to

225 [ 3.7percent] ADR reports.

> 2. The anti-microbial drugs were

> responsible for majority of ADRs [116 (51.6percent)]

followed by the drugs acting on the

> central nervous system [28(12.4percent)] and the

vaccines/sera [23( 10.2)].

> 3. Skin was the most commonly involved system [104 cases

(46.4percent)] followed by

> the Central Nervous System [36 cases (16.1percent)] and the

Gastro-Intestinal Tract [35

> cases (15.6percent)]

> 4. 5[2.6percent ] ADRs resulted in the death of the child, 75

[38.9percent] ADRs resulted in

> hospitalization (initial/prolonged) and 4[2.1percent] had a

life threatening complication and

> 13[6.7percent] children required intervention to prevent

permanent impairment/damage.

>

> 5. Vaccines and ADRs

> 21[36.8percent] ADRs resulted in hospitalization. These were

due to DPT/HBV/OPV

>

> 6. ADRs in the children and the elderly(60+) constitute to

less than 12% of the overall ADR reports when one can expect ADRs

most commonly in these age-groups due to the increased

susceptibility.

>

> Sincerely,

> Dr.Manoj Swaminathan

> Pharmacovigilance Physician

> Sciformix Technologies (P) Ltd.

>

>

>

>

>

>

>

>

> -------------------------------------------------------------------

---------

> Chat on a cool, new interface. No download required. Click

here.

>

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  • 2 months later...

Hi Manoj,

Hope you are doing well. I am not amazed or surprised to see these figures. Why don't you publish this.

Best wishes

Dr Pipasha

ADRs in Children

Hi NetRUMians,I could not resist from sharing what I had seen during my research on the National Pharmacovigilance Programme.Some Major Points on ADRs in U-5 Children:1. The ADRs in the under-5 age group children contributed to 225 [ 3.7percent] ADR reports.2. The anti-microbial drugs wereresponsible for majority of ADRs [116 (51.6percent) ] followed by the drugs acting on thecentral nervous system [28(12.4percent) ] and the vaccines/sera [23( 10.2)].3. Skin was the most commonly involved system [104 cases (46.4percent) ] followed bythe Central Nervous System [36 cases (16.1percent) ] and the Gastro-Intestinal Tract [35cases (15.6percent) ]4. 5[2.6percent ] ADRs resulted in the death of the child, 75[38.9percent] ADRs resulted inhospitalization (initial/prolonged) and 4[2.1percent] had a life threatening complication and13[6.7percent] children required intervention to prevent permanent

impairment/damage. 5. Vaccines and ADRs21[36.8percent] ADRs resulted in hospitalization. These were due to DPT/HBV/OPV6. ADRs in the children and the elderly(60+) constitute to less than 12% of the overall ADR reports when one can expect ADRs most commonly in these age-groups due to the increased susceptibility. Sincerely,Dr.Manoj SwaminathanPharmacovigilance PhysicianSciformix Technologies (P) Ltd.

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hello,

I missed Manoj's mail. but I would like to ask him whether any ADRs were encountered with TM use?

We still believe that TM and alternative medicines are free from ADRs and do not take up this area in Pharmacovigilance.

TM like Ayurvedic medicine has withstood the test of time. It is however the business of manufacturing processes that have led to getting doubts about their efficacy and safety. And ofcourse the western world which asks for scientific proofs like clinical trials.

Are we also not to blame when we have sham institutes giving away fake degrees?

kunda

From: Pipasha Biswas <b_pipasha@...>Subject: Re: ADRs in Childrennetrum Date: Thursday, 14 February, 2008, 7:52 PM

Hi Manoj,

Hope you are doing well. I am not amazed or surprised to see these figures. Why don't you publish this.

Best wishes

Dr Pipasha

ADRs in Children

Hi NetRUMians,I could not resist from sharing what I had seen during my research on the National Pharmacovigilance Programme.Some Major Points on ADRs in U-5 Children:1. The ADRs in the under-5 age group children contributed to 225 [ 3.7percent] ADR reports.2. The anti-microbial drugs wereresponsible for majority of ADRs [116 (51.6percent) ] followed by the drugs acting on thecentral nervous system [28(12.4percent) ] and the vaccines/sera [23( 10.2)].3. Skin was the most commonly involved system [104 cases (46.4percent) ] followed bythe Central Nervous System [36 cases (16.1percent) ] and the Gastro-Intestinal Tract [35cases (15.6percent) ]4. 5[2.6percent ] ADRs resulted in the death of the child, 75[38.9percent] ADRs resulted inhospitalization (initial/prolonged) and 4[2.1percent] had a life threatening complication and13[6.7percent] children required intervention to prevent permanent

impairment/damage. 5. Vaccines and ADRs21[36.8percent] ADRs resulted in hospitalization. These were due to DPT/HBV/OPV6. ADRs in the children and the elderly(60+) constitute to less than 12% of the overall ADR reports when one can expect ADRs most commonly in these age-groups due to the increased susceptibility. Sincerely,Dr.Manoj SwaminathanPharmacovigilance PhysicianSciformix Technologies (P) Ltd.

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Hi

The historical record of growth of MM is short. Humanity has survived,

prospered, bloomed even before MM came up. It is the proof enough that

TM has worked well for centuries.

Yet all medication must be safe for all. TM or Ayurveda, all must

undergo toxicity studies and data must be available for reference. It

was OK in the past era that humans used everything without safety

concerns. Now that the facilities exist, these must be used.

Vijay

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