Re:New Discussion-Over the counter Medicines

[Guest guest]

Dear Members,

In many parts of the world medicines are available only if they have marketing

authorization (a product license), awarded after the manufacturer has supplied

extensive evidence of efficacy and safety.

As a part of the authorization process, a legal status is conferred on a

medicine, which governs its distribution and promotion, with the objective of

balancing issues of safety in use and ease of access.

The volume and value of sales of OTC medicines have increased dramatically in

recent years, so that self-medication products now account for an estimated 18%

of the total global pharmaceutical market. The proportion varies from country to

country but is growing in all areas.

Regards,

Dr. Mangesh Bankar

Nagpur

[Guest guest]

Hi a very timely discussion. I would.request the.moderator to consider discussing about schedule h.and x and the by exclusion granting of otc status prevalent in IndiaIndia

Dr Arif Hashmi

On 31-Jan-2011 12:54 AM, " mangesh bankar " <drmangesh_bankar@...> wrote:> Dear Members,> In many parts of the world medicines are available only if they have marketing authorization (a product license), awarded after the manufacturer has supplied extensive evidence of efficacy and safety.

> As a part of the authorization process, a legal status is conferred on a medicine, which governs its distribution and promotion, with the objective of balancing issues of safety in use and ease of access.> The volume and value of sales of OTC medicines have increased dramatically in recent years, so that self-medication products now account for an estimated 18% of the total global pharmaceutical market. The proportion varies from country to country but is growing in all areas.

> > > Regards,> > Dr. Mangesh Bankar> Nagpur> >

[Guest guest]

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.

[Guest guest]

Thank you for giving me this opportunity to contribute to this important discussion.

In my little experience, I have noted that most people, including health care workers, regularly confuse issues around this important topic- "SCHEDULING OF MEDICINES"...

If I am not mistaken, in most countries, we have three (3) broad schedules:

1. Prescription Only Medicine (POM)

2. Pharmacy Medicine (P- medicine)

3. Over The Counter (OTC).

We are, in most cases, very comfortable with the clarification between "POM" and "P only medicines"- where the first one will only be dispensed by a Pharmacist with a valid prescription by a medical practitioner and in the latter, that the pharmacist can dispense himself / herself, without a prescription. The pharmacist, being a professional too, has the authority to dispense these WIthout a prescription from a medical practitioner ("doctor). They are kept behind in the area which is accessible by the pharmacist and not the public.

The confusion arises with OTC.

OTC to my understanding is Over The Counter in a Pharmacy... That means they are kept within a pharmacy and the patient can actually pick them up and bring to the cashier for purchase. A prescription is again not necessarily required. They can also be kept behind the pharmacist in a secured area away from direct public handling. However, the point remains that it is exchanged over the counter in a pharmacy.

Where we get confused and often forget is that there is another schedule, the 4th, termed:4. General Sales List (GSL)... GSL medicines are also available in public retail outlets such as supermarkets and kiosks. These are not OTC medicines.

We often see GSLs and OTCs, over a period of time, have been merged with each other... Which is very wrong.

The principal reason for these categorization is based on what we know pertaining to the safety of the medicine in question. Most medicines, such as innovator molecules, when they are "new" and very little is known about their safety in the broader population use (i.e. Only data derived from clinical trials is available), are termed Prescription Only Medicines (POMs).

Over a period of time, as we gather the Phase IV (post-market surveillance data), these medicines may move toward P-medicine, OTC etc- as we understand the molecule better and find it safer.

These are my thought and how we are trying to address the situation in Kenya where I practice... I am sure India will have similar thoughts.

Thank you for this opportunity again and happy to be on NETRUM!

Jayesh

Report all Suspected Adverse Drug Reactions to:

----------------------------------------------------------------------------------- 

Jayesh M. Pandit

Head- Department of Pharmacovigilance

Pharmacy and Poisons Board

Lenana Road

Ministry of Medical Services

P.O. Box: 27663-00506

Nairobi, KENYA

www.pharmacyboardkenya.org

(+254-20-) 3562107

(+254-0-) 733884411 / 720608811

(+254-20-) 2713431 / 2713409

(254-0-) 721348503

P Think about our environment!!!

Please do not print this e-mail unless you really need to.

-- Re:New Discussion-Over the counter Medicines

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.

[Guest guest]

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

1 of 1 File(s)

3 Scheduling OTC Medicines to Empower the Consumer.ppt

[Guest guest]

Bravo Gitanjali.

During my last visit to Kushinagar in Bihar, right opposite where Gautama Buddha

attained Nirwana, I saw small kiosks (wooden structures, " bakhdas " in Mumbai

slang)located over a dirty waste drain(nalla), without any board, selling

medicines along with items of daily needs.

The community means business!

Vijay

>

> >

> >

> > 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

>