Stop indiscriminate OTC sale of topical steroid without prescription, most are Schedule H drugs
Stop indiscriminate OTC sale of topical steroid without prescription, most are Schedule H drugs
The Issue
IADVL TASKFORCE AGAINST TOPICAL STEROID ABUSE (ITATSA)
To
To
Drug Controller General of India
Directorate General of Health Services
Ministry of Health and Family Welfare
Government of India
FDA Bhavan, ITO, Kotla Road, New Delhi -110002
Sub: Stop indiscriminate OTC sale of topical steroid without prescription
Twenty-five-year Sucharita Sanyal had been using a common skin cream for her pimples till they turned bigger, spread all over face and started bleeding. She stopped using the ointment but it aggravated the rashes even further. Her condition dramatically, though temporarily, improves if she applies that cream again. But again turns horrible the moment she stops using the cream.
Her condition was eventually diagnosed as Topical Steroid Damaged Face (TSDF) which is triggered by continuous use of strong topical steroids on face. Indiscriminate uses of such creams have resulted in more than 30,000 people in Kolkata and surrounding areas suffering from this ailment, which is not fatal but can’t be cured easily.
A study conducted by the Indian Association of Dermatologists, Venerologists and Leprologists (IADVL), a 7500 member strong organization, in 12 Indian cities reveal some very disturbing facts. The survey was conducted in various centers in Kolkata, Chennai, Bangalore, Lucknow, Baroda, Pune, Udaipur, Dibrugarh, Aligarh and Coimbatore. The study has been published in Indian Journal of Dermatologists, Venereologists and Leprologists(IJDVL)[1]
It showed that most patients had used steroid-laden ointments like Betnovate C and N, Panderm/Panderm Plus, Skinlite, Lobate GM, Melacare or Quadriderm which are available without a prescription.
In most of the cases these medicines were wrongly used to treat dark patches on face or to cure pimples.
These medicines have a high steroid content that may turn the skin thinner, give rise to steroid dependence, increase the pimples or rashes for which you might have been using them, actually aggravate. Other serious complications like hirsutism(unwanted hair growth on face in females), perioral dermatitis, rosacea etc can also develop. The side-effects could even be systemic.
Most are listed under Schedule H drug. These are drugs which cannot be purchased over the counter without the prescription of a qualified doctor
Of these the following are listed under schedule H drug[2]
121. CLOBETASOL PROPIONATE
122. CLOBETASONE 17-BUTYRATE
210. FLUTICASONE PROPIONATE
335. MOMETASONE FUROATE
Hydrocortisone and Betamehasone have also been included in the lastest list of Indian Pharmacopia commission.[3]
None of these are supposed to be sold without prescription.
Unfortunately, these creams and ointments are available over the counter without a prescription by any specialists in India, which is not the case anywhere else in the world.
It was in 2005 when for the first time in India this entity was studied and published [4]
The association of Indian Dermatologists have already approached different authorities but without any effect. The doctors have nothing against steroids which were essential for treating several skin ailments.
A proper dose prescribed by dermatologists is beneficial. But few choose to seek advise before applying these ointments which are meant for diseases like eczema and psoriasis and need to be used in a controlled way.
These tubes are sold in millions and since they come under the umbrella of DPCO (Drug Price control order) they are available at a throwaway price. So, the misuse becomes even more rampant. Since drug rules prohibit over-the-counter sale of potent topical steroids internationally, this entity is virtually unknown in developed countries and naturally there is no prescribed treatment for this problem.
The IADVL launched a public awareness campaign in all the states of the country to keep people away from over-the-counter purchase of skin ointments containing potent steroid.
It could be difficult unless we have a law to fall back on but we must start the campaign for the sake of the millions who are falling prey to TSDF due to their ignorance.
This petition is an attempt to stop the horrific menace of indiscriminate misuse of steroid creams on face without any dermatologist's prescription
There were several efforts to utilise different media channels to sensitize common public about this peril.
Some are as below:
1. Individual blog: http://drlahiri.blogspot.in/2011/04/no-steroid-cream-on-face-without.html?m=1
2. Times of India: http://m.timesofindia.com/city/kolkata/Beware-of-skin-ointments-with-steroids/articleshow/7880043.cms
3. First post: http://m.firstpost.com/living/why-you-should-beware-of-fairness-creams-727071.html
4. Dainik Jagaran: http://epaper.jagran.com/ePaperArticle/30-may-2014-edition-Varanasi-City-page_8-31111-3086-45.html
5.Facebook: https://m.facebook.com/profile.php?id=246358225435319
6. The Indian Society of Teledermatology (INSTED) and the Chennai Chapter of Indian Association of Dermatologists, Venereologists and Leprologists have earlier launched a 'Movement against Topical Steroid Abuse,' (MATSA), a social initiative to create awareness among the general public, patients, parents, physicians, pharmacists and paramedical personnel on the menace of steroid abuse. The MATSA has attracted serious coverage in the print media as seen in the link below
http://www.insted.in/media.php
In a recent article published in 2014 the enormity and expanse of this menace were researched and documented with reference to sales, status, prescriptions and regulatory problems with topical steroids in India .[5]
As per the latest figures Topical steroid sale for 2013 at the end of December stood at Rs. 1400 crores, (Approx. US$233 million**) showing an annual growth of 16%. Most of these sales are OTC (over the counter) without any Dermatologist's prescription.
This is a horrific situation with devastating effect on the Dermatological quality of life of millions in Indian sub-continent which should be immediately dealt with proper and strict enforcement of law related to these molecules.
Nowhere in the world has this happened in such a humongous scale.
Indian Association of Dermatologists, Venereologists and Leprologists(IADVL), the largest representative body of Dermatologists in India has come forward to support this cause.
A new taskforce was formed and was named IADVL Task Force against Topical Steroid Abuse (ITATSA).
On behalf of the IADVL TASKFORCE AGAINST TOPICAL STEROID ABUSE (ITATSA) I request one and all to please sign this petition to put an end to this terrible and disgraceful menace.
Dr. Koushik Lahiri
On behalf of
IADVL TASKFORCE AGAINST TOPICAL STEROID ABUSE (ITATSA)
Cc: MR. J. P. Nadda, The Hon’ble Minister of Health and Family Welfare
References
1. Saraswat A, Lahiri K, Chatterjee M, Barua S, Coondoo A, Mittal A, Panda S, Rajagopalan M, Sharma R, Abraham A, Verma SB, Srinivas C R. Topical corticosteroid abuse on the face: A prospective, multicenter study of dermatology outpatients. Indian J Dermatol Venereol Leprol 2011;77:160-6
2. DRUGS AND COSMETICS (2ND AMENDMENT) RULES, 2006 MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health) NOTIFICATION , New Delhi, the 16th March, 2006
3. National Formulary of India 4th Edition 2011, Government of India, Ministry of Health & Family Welfare, INDIAN PHARMACOPOEIA COMMISSION, Ministry of Health & Family Welfare, Government of India
4. Rathi S. Abuse of topical steroid as cosmetic cream: A social background of steroid dermatitis. Indian J Dermatol 2006;51:154-5
5. Verma SB. Sales, status, prescriptions and regulatory problems with topical steroids in India. Indian J Dermatol, Venereol, leprol 2014; 80: 201-3
The Issue
IADVL TASKFORCE AGAINST TOPICAL STEROID ABUSE (ITATSA)
To
To
Drug Controller General of India
Directorate General of Health Services
Ministry of Health and Family Welfare
Government of India
FDA Bhavan, ITO, Kotla Road, New Delhi -110002
Sub: Stop indiscriminate OTC sale of topical steroid without prescription
Twenty-five-year Sucharita Sanyal had been using a common skin cream for her pimples till they turned bigger, spread all over face and started bleeding. She stopped using the ointment but it aggravated the rashes even further. Her condition dramatically, though temporarily, improves if she applies that cream again. But again turns horrible the moment she stops using the cream.
Her condition was eventually diagnosed as Topical Steroid Damaged Face (TSDF) which is triggered by continuous use of strong topical steroids on face. Indiscriminate uses of such creams have resulted in more than 30,000 people in Kolkata and surrounding areas suffering from this ailment, which is not fatal but can’t be cured easily.
A study conducted by the Indian Association of Dermatologists, Venerologists and Leprologists (IADVL), a 7500 member strong organization, in 12 Indian cities reveal some very disturbing facts. The survey was conducted in various centers in Kolkata, Chennai, Bangalore, Lucknow, Baroda, Pune, Udaipur, Dibrugarh, Aligarh and Coimbatore. The study has been published in Indian Journal of Dermatologists, Venereologists and Leprologists(IJDVL)[1]
It showed that most patients had used steroid-laden ointments like Betnovate C and N, Panderm/Panderm Plus, Skinlite, Lobate GM, Melacare or Quadriderm which are available without a prescription.
In most of the cases these medicines were wrongly used to treat dark patches on face or to cure pimples.
These medicines have a high steroid content that may turn the skin thinner, give rise to steroid dependence, increase the pimples or rashes for which you might have been using them, actually aggravate. Other serious complications like hirsutism(unwanted hair growth on face in females), perioral dermatitis, rosacea etc can also develop. The side-effects could even be systemic.
Most are listed under Schedule H drug. These are drugs which cannot be purchased over the counter without the prescription of a qualified doctor
Of these the following are listed under schedule H drug[2]
121. CLOBETASOL PROPIONATE
122. CLOBETASONE 17-BUTYRATE
210. FLUTICASONE PROPIONATE
335. MOMETASONE FUROATE
Hydrocortisone and Betamehasone have also been included in the lastest list of Indian Pharmacopia commission.[3]
None of these are supposed to be sold without prescription.
Unfortunately, these creams and ointments are available over the counter without a prescription by any specialists in India, which is not the case anywhere else in the world.
It was in 2005 when for the first time in India this entity was studied and published [4]
The association of Indian Dermatologists have already approached different authorities but without any effect. The doctors have nothing against steroids which were essential for treating several skin ailments.
A proper dose prescribed by dermatologists is beneficial. But few choose to seek advise before applying these ointments which are meant for diseases like eczema and psoriasis and need to be used in a controlled way.
These tubes are sold in millions and since they come under the umbrella of DPCO (Drug Price control order) they are available at a throwaway price. So, the misuse becomes even more rampant. Since drug rules prohibit over-the-counter sale of potent topical steroids internationally, this entity is virtually unknown in developed countries and naturally there is no prescribed treatment for this problem.
The IADVL launched a public awareness campaign in all the states of the country to keep people away from over-the-counter purchase of skin ointments containing potent steroid.
It could be difficult unless we have a law to fall back on but we must start the campaign for the sake of the millions who are falling prey to TSDF due to their ignorance.
This petition is an attempt to stop the horrific menace of indiscriminate misuse of steroid creams on face without any dermatologist's prescription
There were several efforts to utilise different media channels to sensitize common public about this peril.
Some are as below:
1. Individual blog: http://drlahiri.blogspot.in/2011/04/no-steroid-cream-on-face-without.html?m=1
2. Times of India: http://m.timesofindia.com/city/kolkata/Beware-of-skin-ointments-with-steroids/articleshow/7880043.cms
3. First post: http://m.firstpost.com/living/why-you-should-beware-of-fairness-creams-727071.html
4. Dainik Jagaran: http://epaper.jagran.com/ePaperArticle/30-may-2014-edition-Varanasi-City-page_8-31111-3086-45.html
5.Facebook: https://m.facebook.com/profile.php?id=246358225435319
6. The Indian Society of Teledermatology (INSTED) and the Chennai Chapter of Indian Association of Dermatologists, Venereologists and Leprologists have earlier launched a 'Movement against Topical Steroid Abuse,' (MATSA), a social initiative to create awareness among the general public, patients, parents, physicians, pharmacists and paramedical personnel on the menace of steroid abuse. The MATSA has attracted serious coverage in the print media as seen in the link below
http://www.insted.in/media.php
In a recent article published in 2014 the enormity and expanse of this menace were researched and documented with reference to sales, status, prescriptions and regulatory problems with topical steroids in India .[5]
As per the latest figures Topical steroid sale for 2013 at the end of December stood at Rs. 1400 crores, (Approx. US$233 million**) showing an annual growth of 16%. Most of these sales are OTC (over the counter) without any Dermatologist's prescription.
This is a horrific situation with devastating effect on the Dermatological quality of life of millions in Indian sub-continent which should be immediately dealt with proper and strict enforcement of law related to these molecules.
Nowhere in the world has this happened in such a humongous scale.
Indian Association of Dermatologists, Venereologists and Leprologists(IADVL), the largest representative body of Dermatologists in India has come forward to support this cause.
A new taskforce was formed and was named IADVL Task Force against Topical Steroid Abuse (ITATSA).
On behalf of the IADVL TASKFORCE AGAINST TOPICAL STEROID ABUSE (ITATSA) I request one and all to please sign this petition to put an end to this terrible and disgraceful menace.
Dr. Koushik Lahiri
On behalf of
IADVL TASKFORCE AGAINST TOPICAL STEROID ABUSE (ITATSA)
Cc: MR. J. P. Nadda, The Hon’ble Minister of Health and Family Welfare
References
1. Saraswat A, Lahiri K, Chatterjee M, Barua S, Coondoo A, Mittal A, Panda S, Rajagopalan M, Sharma R, Abraham A, Verma SB, Srinivas C R. Topical corticosteroid abuse on the face: A prospective, multicenter study of dermatology outpatients. Indian J Dermatol Venereol Leprol 2011;77:160-6
2. DRUGS AND COSMETICS (2ND AMENDMENT) RULES, 2006 MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health) NOTIFICATION , New Delhi, the 16th March, 2006
3. National Formulary of India 4th Edition 2011, Government of India, Ministry of Health & Family Welfare, INDIAN PHARMACOPOEIA COMMISSION, Ministry of Health & Family Welfare, Government of India
4. Rathi S. Abuse of topical steroid as cosmetic cream: A social background of steroid dermatitis. Indian J Dermatol 2006;51:154-5
5. Verma SB. Sales, status, prescriptions and regulatory problems with topical steroids in India. Indian J Dermatol, Venereol, leprol 2014; 80: 201-3
Petition Closed
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Petition created on 22 May 2014