Re: New Discussion-Over the counter Medicines

[Guest guest]

Dear Dr Gitanjali Madam, Dr Mangesh and all:

I think this is a very important topic of discussion considering its repercussions on the daily usage of medications for minor ailments by the common masses. In India Drugs and Cosmetics Act of 1940 is in vogue and that as rightly mentioned by you does not provide a list or separate schedule for OTC medicines. However there is a provision, for what the Act terms as "Restricted Drug Sale Licence" that is issued on Form No. 20A and does not require the services of a qualified pharmacist. Even an itinerant vendor or anybody who desires to establish a shop in a village or town having a population of 5000 or less can be issued such a licence.

Furthermore as rightly mentioned by Dr Weerasuraya in one of the slides of his informative PPT (attached by Dr Gitanjali), under Schedule K of the Drugs and Cosmetics Rules 1945, a list of "Household Remedies" have been specified that have been exempted from being covered by a drug sale licence (on some conditions though). I would like to add that this list of drugs includes aspirin, paracetamol tablets, analgesic balms, antacid preparations, gripe water for infants, inhalers for cold and nasal congestion; syrups, lozenges, pills and tablets for cough; skin ointments and ointments for burns, absorbent cotton wool, bandages, absorbent gauze and adhesive plasters; castor oil, liquid paraffin, epson salt, eucalyptus oil, tincture iodine, tincture benzoin, quinine sulphate tablets. The conditions of exemption are that these drugs should be sold only in a village having a population of

not more than one thousand persons and where there is no licensed dealer, the drugs should not contain any substance specified in Schedule G, H or X and the drugs should be sold in the original unopened containers of the licensed manufacturers.

Then certain substances which fall under the definition of "drugs" but are "not for medicinal use" like food supplements, minerals, nutrients etc too are exempted from sale under the cover of a drug licence. I do second the views of Dr Weerasuraya and Dr Gitanjali that we need to empower the consumer by bringing in legislation to permit OTC drugs to be sold in a more broad-based manner.

Further all the drugs that are not listed under Schedule H (prescription drugs) cannot be considered as OTC medicines because there is Schedule G too that we cannot afford to ignore. Drugs falling under Schedule G have the label "Caution: It is dangerous to take these drugs except under medical supervision". They may not necessarily require a prescription always but can not be considered as OTC medicines. Therefore as per existing legal norms, only drugs listed above as household remedies under Schedule K of D & C Act can be sold without a drug sale licence after observing the conditions mentioned thereunder. I shall have to check if this list has been modified/updated in the recent ammendments to the Act.

With Regards

Geer M. Ishaq

Sr. Assistant Professor

Dept. of Pharmaceutical Sciences

University of Kashmir

Srinagar-190006 (J & K)

Ph: 9906673100, 01942429503

http://www.sites.google.com/site/ishaqgeer

From: Gitanjali Batmanabane <gitabatman@...>netrum Sent: Mon, 31 January, 2011 3:41:31 PMSubject: Re: Re:New Discussion-Over the counter Medicines [1 Attachment]

Dear Netrumians

Great posts by Jayesh Pandit and Om Singh.

I would like to share a presentation made by Dr Weerasuriya (former Regional Advisor for Essential Drugs and Other Medicines, WHO-SEARO) and myself at the Intercountry Meeting on Rational Use of Medicines at SEARO-WHO, New Delhi in July 2010.

The idea we wanted to put across was that in India there is no list of OTC drugs. If a person has a headache he has to go to a chemist shop to buy paracetamol. The so called 'OTC' drugs can 'only' be sold in chemist (pharmacy) shops. Can we not empower the consumer by bringing in legislation to permit these drugs to be sold in all shops - maybe even in a small 'tea boutique' in a village? This is on the lines of what is going on in Kenya, mentioned by Jayesh. Of course there are issues with that, but 'responsible self-medication' may be a laudable goal.

This presentation is quite large - I have removed some of the cartoons and stuff to make it smaller.

Hope you enjoy the presentation.

Gitanjali

On Mon, Jan 31, 2011 at 9:58 AM, om singh <opsingh.india@...> wrote:

Dear Members,

That's a great initiative.

‘OTC Drugs’ means drugs legally allowed to be sold ‘Over the Counter’, i.e. without the prescription of a Registered Medical Practitioner. In India, though Prescription Drugs are those that fall under two schedules of the Drug and Cosmetics Rules, 1945: Schedule H and Schedule X. The market for OTC healthcare in India increased at a compound annual growth rate of 6.4% between 2004 and 2009. The vitamins and minerals category led the OTC healthcare market in India, accounting for a share of 23.8%. Leading players in Indian OTC healthcare market include Cipla Ltd, & and GlaxoKline Plc. The OTC market in India has following possible benefits:

1. Better Accessibility 2. Lower healthcare costs

3. Educated consumers Possible risks of OTC market may be as follows:

1. Inappropriate and Inaccurate diagnosis 2. Increased cost to patients

3. Use of wrong medications 4. Increased drug resistance 5. Adverse effects, drug reactions not reported There is vital need to design interventions to modify the behavior of everyone involved in the pharmaceutical supply chain from producer to consumers to combat the inappropriate drug use and rationalize the OTC consumption. The OTC drug offering is incomplete without empowering the public on its rational use through well planed strategic marketing and educating retail pharmacist on the use of OTC.

O.P.Singh

Consultant Health Research and Managment

194-B, 4 C Jamunapuri Colony,

Murlipura Scheme,

Jaipur 302013

Rajasthan India.

-- Dr.Gitanjali Batmanabane Pondicherry

[Guest guest]

Dear Geer

 

Thanks for your very well written post. Before I made the presentation last July, I did extensive reading up on the subject as I was totally unfamiliar with it and surprised with what I found was going on in India.

 

It is ridiculous that paracetamol can be sold in a village with less than 1000 population by a vegetable shop owner, but not in a supermarket in a city. What Kris and I were trying to say is that simple medicines paracetamol, ORS, ointment for burns etc., (the list on your household remedies) should be permitted to be sold by anyone, everywhere. In Sri Lanka, paracetamol is sold under the brand name Panadol. ORS is sold under the brand name 'Jeevani'. People are encouraged to use ORS if they have diarrhoea and told to see a doctor if it persists for two days or other symptoms like fever etc., appear. Is this not better than someone with diarrhoea going to the chemist shop, telling the chemist " I have diarrhoea " and the chemist (who probably will not even be a pharmacist in the first place) giving him Ornidazole+Ofloxacin combination for three days and no ORS?

 

We have to look at this in totality. a) Permit these Household Remedies to be sold everywhere - I do not recommend anything else other than the simplest ones to be sold like this  Make sure the advertising is ethical  c) Have on-going consumer education d) Enforce the law

 

Doctors often fear that giving people the knowledge to make proper choices will somehow undermine their importance. This is what leads to people doing exactly what they should not be doing. A woman with dymenorrhoea should be able to buy some analgesics whether she lives in a village with 1000 people or in a city with ten lakh people. She should not have to wait for a chemist shop to open to buy that analgesic. - This is what I believe.

 

  

On Mon, Jan 31, 2011 at 11:23 PM, Geer M. Ishaq <ishaqgeer@...> wrote:

 

Dear Dr Gitanjali Madam, Dr Mangesh and all:

 

I think this is a very important topic of discussion considering its repercussions on the daily usage of medications for minor ailments by the common masses. In India Drugs and Cosmetics Act of 1940 is in vogue and that as rightly mentioned by you does not provide a list or separate schedule for OTC medicines. However there is a provision, for what the Act terms as " Restricted Drug Sale Licence " that is issued on Form No. 20A and does not require the services of a qualified pharmacist. Even an itinerant vendor or anybody who desires to establish a shop in a village or town having a population of 5000 or less can be issued such a licence. 

 

Furthermore as rightly mentioned by Dr Weerasuraya in one of the slides of his informative PPT (attached by Dr Gitanjali), under Schedule K of the Drugs and Cosmetics Rules 1945, a list of   " Household Remedies " have been specified that have been exempted from being covered by a drug sale licence (on some conditions though). I would like to add that this list of drugs includes aspirin, paracetamol tablets, analgesic balms, antacid preparations, gripe water for infants, inhalers for cold and nasal congestion; syrups, lozenges, pills and tablets for cough; skin ointments and ointments for burns, absorbent cotton wool, bandages, absorbent gauze and adhesive plasters; castor oil, liquid paraffin, epson salt, eucalyptus oil, tincture iodine, tincture benzoin, quinine sulphate tablets. The conditions of exemption are that these drugs should be sold only in a village having a population of not more than one thousand persons and where there is no licensed dealer, the drugs should not contain any substance specified in Schedule G, H or X and the drugs should be sold in the original unopened containers of the licensed manufacturers.

 

Then certain substances which fall under the definition of " drugs " but are " not for medicinal use " like food supplements, minerals, nutrients etc too are exempted from sale under the cover of a drug licence. I do second the views of Dr Weerasuraya and Dr Gitanjali that we need to empower the consumer by bringing in legislation to permit OTC drugs to be sold in a more broad-based manner.   

 

Further all the drugs that are not listed under Schedule H (prescription drugs) cannot be considered as OTC medicines because there is Schedule G too that we cannot afford to ignore. Drugs falling under Schedule G have the label  " Caution: It is dangerous to take these drugs except under medical supervision " . They may not necessarily require a prescription always but can not be considered as OTC medicines. Therefore as per existing legal norms, only drugs listed above as household remedies under Schedule K of D & C Act can be sold without a drug sale licence after observing the conditions mentioned thereunder.  I shall have to check if this list has been modified/updated in the recent ammendments to the Act.

With Regards 

Geer M. Ishaq

Sr. Assistant Professor

Dept. of Pharmaceutical Sciences

University of Kashmir

Srinagar-190006 (J & K)

Ph: 9906673100, 01942429503

http://www.sites.google.com/site/ishaqgeer

From: Gitanjali Batmanabane <gitabatman@...>netrum

Sent: Mon, 31 January, 2011 3:41:31 PMSubject: Re: Re:New Discussion-Over the counter Medicines [1 Attachment]

 

Dear Netrumians

 

Great posts by Jayesh Pandit and Om Singh.

 

I would like to share a presentation made by Dr Weerasuriya (former Regional Advisor for Essential Drugs and Other Medicines, WHO-SEARO) and myself at the Intercountry Meeting on Rational Use of Medicines at SEARO-WHO, New Delhi in July 2010.

 

The idea we wanted to put across was that in India there is no list of OTC drugs. If a person has a headache he has to go to a chemist shop to buy paracetamol. The so called 'OTC' drugs can 'only' be sold in chemist (pharmacy) shops.  Can we not empower the consumer by bringing in legislation to permit these drugs to be sold in all shops - maybe even in a small 'tea boutique' in a village? This is on the lines of what is going on in Kenya, mentioned by Jayesh. Of course there are issues with that, but 'responsible self-medication' may be a laudable goal.

 

This presentation is quite large - I have removed some of the cartoons and stuff to make it smaller.

Hope you enjoy the presentation.

 

Gitanjali

 

 

On Mon, Jan 31, 2011 at 9:58 AM, om singh <opsingh.india@...> wrote:

 

Dear Members,

That's a great initiative.

 

‘OTC Drugs’ means drugs legally allowed to be sold ‘Over the Counter’, i.e. without the prescription of a Registered Medical Practitioner. In India, though Prescription Drugs are those that fall under two schedules of the Drug and Cosmetics Rules, 1945: Schedule H and Schedule X. The market for OTC healthcare in India increased at a compound annual growth rate of 6.4% between 2004 and 2009. The vitamins and minerals category led the OTC healthcare market in India, accounting for a share of 23.8%. Leading players in Indian OTC healthcare market include Cipla Ltd, & and GlaxoKline Plc.   The OTC market in India has following possible benefits:

1. Better Accessibility 2. Lower healthcare costs

3. Educated consumers   Possible risks of OTC market may be as follows:

1. Inappropriate and Inaccurate diagnosis 2. Increased cost to patients

3. Use of wrong medications 4. Increased drug resistance 5. Adverse effects, drug reactions not reported     There is vital need to design interventions to modify the behavior of everyone involved in the pharmaceutical supply chain from producer to consumers to combat the inappropriate drug use and rationalize the OTC consumption. The OTC drug offering is incomplete without empowering the public on its rational use through well planed strategic marketing and educating retail pharmacist on the use of OTC.

 

O.P.Singh

Consultant Health Research and Managment

194-B, 4 C Jamunapuri Colony,

Murlipura Scheme,

Jaipur 302013

Rajasthan India.

 

-- Dr.Gitanjali Batmanabane Pondicherry

-- Dr.Gitanjali Batmanabane Pondicherry

[Guest guest]

Dear Dr Gitanjali Madam:

Your concerns are genuine and reasonable. I have already seconded your viewpoint in my previous post. OTC is one of the many key areas of D & C Act that desperately need revision and some drastic ammendment. In one of my articles I have written about some of such grey areas that need to be appropriately addressed. Since this topic of discussion pertains specifically to OTC, I won't touch upon those issues here. While endorsing your assertion that OTC medicines need to be made available in all shops without any licence, I wish to submit that there are certain concerns in that regard.

First and foremost being that of safety since these drugs will become available to people at large (literate as well as illiterate) who will be using them without any medical advice. Illiterate shall not be able to follow the label directions with regards use, warnings, discontinuation etc. Overdose and prolonged use are other concerns. Then use of drugs meant for adults by children, contra-indicated persons etc. This may not be the problem with all OTC medicines but with drugs like anti-histaminics (currently under Schedule G) it does. To counter this labelling needs to be made easy and informative. Local languages need to be used to the maximum extent possible (though in India it will pose another problem considering the vast no of local languages that we have). Having said that these concerns should not become a hurdle in the expansion of OTC market. As rightly mentioned by you greater

awareness among the masses regarding their usage shall pave the way. Marketing and advertising of such drugs needs to be appropriately regulated too.

With Regards

Geer M. Ishaq

Sr. Assistant Professor

Dept. of Pharmaceutical Sciences

University of Kashmir

Srinagar-190006 (J & K)

Ph: 9906673100, 01942429503

http://www.sites.google.com/site/ishaqgeer

From: Gitanjali Batmanabane <gitabatman@...>netrum Sent: Tue, 1 February, 2011 12:05:58 PMSubject: Re: Re: New Discussion-Over the counter Medicines

Dear Geer

Thanks for your very well written post. Before I made the presentation last July, I did extensive reading up on the subject as I was totally unfamiliar with it and surprised with what I found was going on in India.

It is ridiculous that paracetamol can be sold in a village with less than 1000 population by a vegetable shop owner, but not in a supermarket in a city. What Kris and I were trying to say is that simple medicines paracetamol, ORS, ointment for burns etc., (the list on your household remedies) should be permitted to be sold by anyone, everywhere. In Sri Lanka, paracetamol is sold under the brand name Panadol. ORS is sold under the brand name 'Jeevani'. People are encouraged to use ORS if they have diarrhoea and told to see a doctor if it persists for two days or other symptoms like fever etc., appear. Is this not better than someone with diarrhoea going to the chemist shop, telling the chemist "I have diarrhoea" and the chemist (who probably will not even be a pharmacist in the first place) giving him Ornidazole+Ofloxacin combination for three days and no ORS?

We have to look at this in totality. a) Permit these Household Remedies to be sold everywhere - I do not recommend anything else other than the simplest ones to be sold like this Make sure the advertising is ethical c) Have on-going consumer education d) Enforce the law

Doctors often fear that giving people the knowledge to make proper choices will somehow undermine their importance. This is what leads to people doing exactly what they should not be doing. A woman with dymenorrhoea should be able to buy some analgesics whether she lives in a village with 1000 people or in a city with ten lakh people. She should not have to wait for a chemist shop to open to buy that analgesic. - This is what I believe.

On Mon, Jan 31, 2011 at 11:23 PM, Geer M. Ishaq <ishaqgeer@...> wrote:

Dear Dr Gitanjali Madam, Dr Mangesh and all:

I think this is a very important topic of discussion considering its repercussions on the daily usage of medications for minor ailments by the common masses. In India Drugs and Cosmetics Act of 1940 is in vogue and that as rightly mentioned by you does not provide a list or separate schedule for OTC medicines. However there is a provision, for what the Act terms as "Restricted Drug Sale Licence" that is issued on Form No. 20A and does not require the services of a qualified pharmacist. Even an itinerant vendor or anybody who desires to establish a shop in a village or town having a population of 5000 or less can be issued such a licence.

Furthermore as rightly mentioned by Dr Weerasuraya in one of the slides of his informative PPT (attached by Dr Gitanjali), under Schedule K of the Drugs and Cosmetics Rules 1945, a list of "Household Remedies" have been specified that have been exempted from being covered by a drug sale licence (on some conditions though). I would like to add that this list of drugs includes aspirin, paracetamol tablets, analgesic balms, antacid preparations, gripe water for infants, inhalers for cold and nasal congestion; syrups, lozenges, pills and tablets for cough; skin ointments and ointments for burns, absorbent cotton wool, bandages, absorbent gauze and adhesive plasters; castor oil, liquid paraffin, epson salt, eucalyptus oil, tincture iodine, tincture benzoin, quinine sulphate tablets. The conditions of exemption are that these drugs should be sold only in a village having a population of

not more than one thousand persons and where there is no licensed dealer, the drugs should not contain any substance specified in Schedule G, H or X and the drugs should be sold in the original unopened containers of the licensed manufacturers.

Then certain substances which fall under the definition of "drugs" but are "not for medicinal use" like food supplements, minerals, nutrients etc too are exempted from sale under the cover of a drug licence. I do second the views of Dr Weerasuraya and Dr Gitanjali that we need to empower the consumer by bringing in legislation to permit OTC drugs to be sold in a more broad-based manner.

Further all the drugs that are not listed under Schedule H (prescription drugs) cannot be considered as OTC medicines because there is Schedule G too that we cannot afford to ignore. Drugs falling under Schedule G have the label "Caution: It is dangerous to take these drugs except under medical supervision". They may not necessarily require a prescription always but can not be considered as OTC medicines. Therefore as per existing legal norms, only drugs listed above as household remedies under Schedule K of D & C Act can be sold without a drug sale licence after observing the conditions mentioned thereunder. I shall have to check if this list has been modified/updated in the recent ammendments to the Act.

With Regards

Geer M. Ishaq

Sr. Assistant Professor

Dept. of Pharmaceutical Sciences

University of Kashmir

Srinagar-190006 (J & K)

Ph: 9906673100, 01942429503

http://www.sites.google.com/site/ishaqgeer

From: Gitanjali Batmanabane <gitabatman@...>netrum Sent: Mon, 31 January, 2011 3:41:31 PMSubject: Re: Re:New Discussion-Over the counter Medicines [1 Attachment]

Dear Netrumians

Great posts by Jayesh Pandit and Om Singh.

I would like to share a presentation made by Dr Weerasuriya (former Regional Advisor for Essential Drugs and Other Medicines, WHO-SEARO) and myself at the Intercountry Meeting on Rational Use of Medicines at SEARO-WHO, New Delhi in July 2010.

The idea we wanted to put across was that in India there is no list of OTC drugs. If a person has a headache he has to go to a chemist shop to buy paracetamol. The so called 'OTC' drugs can 'only' be sold in chemist (pharmacy) shops. Can we not empower the consumer by bringing in legislation to permit these drugs to be sold in all shops - maybe even in a small 'tea boutique' in a village? This is on the lines of what is going on in Kenya, mentioned by Jayesh. Of course there are issues with that, but 'responsible self-medication' may be a laudable goal.

This presentation is quite large - I have removed some of the cartoons and stuff to make it smaller.

Hope you enjoy the presentation.

Gitanjali

On Mon, Jan 31, 2011 at 9:58 AM, om singh <opsingh.india@...> wrote:

Dear Members,

That's a great initiative.

‘OTC Drugs’ means drugs legally allowed to be sold ‘Over the Counter’, i.e. without the prescription of a Registered Medical Practitioner. In India, though Prescription Drugs are those that fall under two schedules of the Drug and Cosmetics Rules, 1945: Schedule H and Schedule X. The market for OTC healthcare in India increased at a compound annual growth rate of 6.4% between 2004 and 2009. The vitamins and minerals category led the OTC healthcare market in India, accounting for a share of 23.8%. Leading players in Indian OTC healthcare market include Cipla Ltd, & and GlaxoKline Plc. The OTC market in India has following possible benefits:

1. Better Accessibility 2. Lower healthcare costs

3. Educated consumers Possible risks of OTC market may be as follows:

1. Inappropriate and Inaccurate diagnosis 2. Increased cost to patients

3. Use of wrong medications 4. Increased drug resistance 5. Adverse effects, drug reactions not reported There is vital need to design interventions to modify the behavior of everyone involved in the pharmaceutical supply chain from producer to consumers to combat the inappropriate drug use and rationalize the OTC consumption. The OTC drug offering is incomplete without empowering the public on its rational use through well planed strategic marketing and educating retail pharmacist on the use of OTC.

O.P.Singh

Consultant Health Research and Managment

194-B, 4 C Jamunapuri Colony,

Murlipura Scheme,

Jaipur 302013

Rajasthan India.

-- Dr.Gitanjali Batmanabane Pondicherry

-- Dr.Gitanjali Batmanabane Pondicherry