OVER THE COUNTER DRUG

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EVOLUTION OF OVER THE COUNTER DRUG

History,Tragedy,Outcomes

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HISTORY
ROSE Case in 1704. Set benchmark in the history of medicines. Pharmacist can prescribe and dispense medicines breaking the monopoly of college of physicians. Available till 1860. After few set back continued till 1960.

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TRAGEDY AND OUTCOMES

1848190219061911 19381962-

Drug importation act Biologics control act(Virus serum toxin act) Wileys act(Pure food and drug act) Shirley's amendment Sulphonelamyl tragedy Thalidomide tragedy

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OUTCOMES

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OVER THE COUNTER DRUG

Over-the-counter (OTC) drugs are drugs and combinations that do not require a registered medical practioner prescription. Many OTC drug ingredients had been previously approved prescription drugs now deemed safe enough for use without a medical practioner's supervision.

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OTHER TYPES OF DRUGS

PRESCRIPTION DRUG Drugs which require valid prescription from a registered medical practioner.

ME TOO DRUG Drugs which are very similar to known or existing drug with only minor differences.
BEHIND THE COUNTER DRUG Drugs which doesnt require Doctors prescription but requires discussion with Pharmacist prior to purchase
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FLOW OF PRESCRIPTION DRUG

Health problem Visit to doctor

Prescribed medicine bought from pharmacist

Consumed under supervision of doctor

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FLOW OF BEHIND/OVER THE COUNTER DRUG

Health problem Visit to Pharmacy Discuss with Pharmacist/Buy the medicine

Consumed
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OTC (WORLD WIDE)

21% 37% 10% 78%
Pain

cough and cold

Allergy and sinus Heart burn and stomach

45%
52%

Constipation and diarrhea Skin problens

SOURCE: CIA World fact book

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POSSIBLE BENEFITS
Increased access Decreased frequency of visits to physicians, leading to lower healthcare costs Improved education of consumers Increased autonomy of patients Decreased cost to third party players

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POSSIBLE RISKS

Inaccurate diagnosis Drug resistance Increased costs to patients Failure to follow label instructions (Adverse effects, Drug interactions) Perceived loss of control by physicians

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THALIDOMIDE TRAGEDY

NEVER GIVE UP !!

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INDIAN CONTEXT
Control,Regulation,Sales

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INDIAN OTC
The Phrase OTC have no legal recognition. The Drugs which are not included in the PRESCRIPTION only considered as OTC. No official list of OTC.

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INDIAN OTC
PRESCRIPTION Only Drugs are included in Schedule H and Schedule X of DCR.

Schedule G doesnt require Prescription but requires Mandatory labeling. Schedule K can be sold under Non-Drug License Store.

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INDIAN OTC
Ayurvedic medicines(natural and herbal ingredients) regulated by DCA and DCR. Manufacturing license is giving by State authority and doesnt require Drug license to sell. It includes Plant based active ingredient( ex. Vicks vaporub, Amrutanjan pain balm, Iodex pain balm, Moov, etc.)

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INDIAN OTC

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Broadly Indian OTC Categories include, Traditional medicines Cough and cold Vitamins and minerals Analgesics Skin problem Others(Antacid,Constipation,Diarrhea,Allergy)
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INDIAN OTC MARKET SHARE

27.30%

27.60%

Traditional medicine Cough and cold

2.60%

11.40% 11.60%

Vitamins and minerals

19.80%

Analgesics Medicated skin products Others

SOURCE: OTC Market by Ajith panninchukanath

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OTC SOLD IN INDIA

1.40% 12.49% 12.59% 73.53%

Specialist retailers Super markets Drug stores Others

SOURCE: CIA World fact book

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FEW INDIAN OTC

Cough, cold and fever
Head aches, body aches and sprains

Codine phosphate, Cetrizine, Paracetamol, etc

Ibuprofen, Paracetamol, Diclofenac, Volini gel, etc Gelusil syrup, Lopipramide, Dulcolux, Domperidone, etc Clearsil, Betadine, Soframycin, etc

GI ailments like acidity, constipation, diarrhea, nausea Skin ailments like acne, rashes, cuts and burns Nutritional supplements
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Bcosules, Protinex, Chavan prash, etc

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INDIAN OTC REGULATION

Medicines in India are regulated by Central Drug Standard Control Organization(CDSCO)

Under the Ministry of Health and Welfare of India

Headed by Director Control General of Health Services regulated by Drug Control Act (DCA)

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PATIENT INFORMATION
Patient information Rule 96 of DCR mandates the minimum information which needs to be put on the label Proper(generic)and trade(brand) name Active ingredients and net contents Name and address of the manufacture/ license number/batch number/expiry date Maximum retail price(Inclusive of all taxes)
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TRADE NAMES
Trade names Regulated by Trade and merchandise marks act(TMMA) Provides registration for the period of seven years at a time and renewable after each period Foreign trade mark can be used without any restriction with their local subsidiaries or joint ventures

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ADVERTISEMENTS
Advertising of OTC Drugs and magic remedies(objectionable advertisements) act and rules mention certain ailments for which no advertisements is permitted False or Misleading advertisements No specific laws governing the advertisements
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SOME OF THE OTCS

MOOV AD GELUSIL AD GLUCOSE AD SARIDON AD

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NATIONAL PHARMACEUTICAL POLICY

Strengthen the Patent office infrastructure Focus to R&D strategies to increase anti cancer and anti HIV drug Rationalize excise duty to promote more access for poor Set up Drugs price monitoring awareness and accessibility fund Create a Pharma advisory Forum
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WHAT DRUG HAS DONE?

1951-2008 Life expectancy 37-68 yrs of age Infant mortality 150-134/1000 births Death rate 25-6/1000 inhabitants Birth rate 22-41/1000 inhabitants

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The Indian pharmaceutical industry is a success story providing employment for millions and ensuring that essential drugs at affordable prices are available to the vast population of this sub-continent. Richard Gerster

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MARKET AND MARKET RESEARCH

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INDIAN MARKET
Indian pharmaceutical market as on october 2010 is valued around Rs 50,000 crore

Globally value - 1.8% and ranks 14th

Globally volume-8% and ranks 4th OTC- India 11th position globally
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INDIAN OTC MARKET

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SOURCE: Nicholas Hall and Company

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INDIAN OTC MARKET

Growth drivers Income demographics Aging population and new social disease

Barriers Doctors willingness High media cost

Increasing health consciousness

Increasing attitude for self medication

Prohibition from advertisements

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Consumer Research
Research Methodology Research Type No. of Respondents Age Group Gender - Male - Female Non-Probability (Convenient Sampling) 99 16-44 73 26

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INDIAN BEHAVIOUR IN ILLNESS

8.91% 22.77% 44.55%

23.76%

Doctor
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Self medication
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1. How do you feel if your Doctor is enquiring about the medicine you have taken before consulting him/her?

Q1. He/She should do it routinely?

Yes No Don't Know Can't Say

10% 25% 45%

20%

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1. How do you feel if your Doctor is enquiring about the medicine you have taken before consulting him/her?

Q2. It would be good sometimes

Yes No Don't Know Can't Say

5% 30%

35%

30%

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1. How do you feel if your Doctor is enquiring about the medicine you have taken before consulting him/her?

Q3. I wouldnt mind one way or other

Yes No Don't Know Can't Say

2% 33% 38%

27%

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1. How do you feel if your Doctor is enquiring about the medicine you have taken before consulting him/her?

Q4. I would be upset if he/she did

Yes No Don't Know Can't Say

9% 22%

20%

49%

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2. Q1. The chemist is a good source for advice/information for minor medical problems
Stongly Agree Agree Disagree Strongly Disagree No Response

5% 1%

11%

21%

64%

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2. Q2. It is important to have medicines /treatments that you can buy to relieve minor medical problem

Stongly Agree

Agree

Disagree

Strongly Disagree

No Response

1% 7%

14%

22%

56%

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2. Q3. Reading the pack is one of the way I decide which medicines/treatments to go for.

Stongly Agree

Agree

Disagree

Strongly Disagree

No Response

3% 12%

15%

18%

52%

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2. Q4. A person should take medicines

/treatments only when it is necessary

Stongly Agree Agree Disagree Strongly Disagree No Response

4% 1%

10%

48%
37%

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2. Q5. You get good value from doctors prescription

Stongly Agree

Agree

Disagree

Strongly Disagree

No Response

4% 13%

13%

28%

42%

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2. Q6. It is perfectly safe to take any medicines /treatments

Stongly Agree

Agree

Disagree

Strongly Disagree

No Response

3% 13% 3% 38% 43%

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2. Q7. If I have a problem I prefer to avoid any medicines/treatments

Stongly Agree

Agree

Disagree

Strongly Disagree

No Response

4%

17%

5% 34%

40%

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2. Q8. I sometimes cant afford to get all items on a

prescription issued by doctor

Stongly Agree Agree Disagree Strongly Disagree No Response

28%

12% 25%

6% 29%

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2. Q9. I sometimes cant afford to get medicines/treatments that

I would like to buy myself (without prescription)

Stongly Agree

Agree

Disagree

Strongly Disagree

No Response

23% 5%

11% 31%

30%

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2. Q10. Even when using medicines/treatments that you can buy

but careful with it

Stongly Agree

Agree

Disagree

Strongly Disagree

No Response

1% 0%

14% 42%

43%

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2. Q11. People are less likely to bother their doctor with minor

problem nowadays

Stongly Agree

Agree

Disagree

Strongly Disagree

No Response

2% 15%

15%

16%

52%

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2. Q12. Only medicines/treatments from doctor will really help

Stongly Agree

Agree

Disagree

Strongly Disagree

No Response

8%

12%

13% 19%

48%

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2. Q13. For some health problems. Medicines /treatments you

can buy are effective as those you get from doctor

Stongly Agree

Agree

Disagree

Strongly Disagree

No Response

3%

19%

6%

18%

54%

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2. Q14. Advertising helps you to learn what type of brands of

medicines/treatments you can buy

Stongly Agree

Agree

Disagree

Strongly Disagree

No Response

4%

15%

9%

21% 51%

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2. Q15. The medicines/treatments you can buy are of good value

Stongly Agree

Agree

Disagree

Strongly Disagree

No Response

2% 21% 3% 50% 24%

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2. Q16. If I am sure about a problem I always look for advice

from doctor/nurse

Stongly Agree

Agree

Disagree

Strongly Disagree

No Response

1% 6% 10% 36%

47%

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2. Q17. I read instruction carefully before taking any

medicines/treatments for the first time

Stongly Agree

Agree

Disagree

Strongly Disagree

No Response

1%

0% 12%

34%

53%

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2. Q18. If you take the same medicines /treatments too often, it

may not be effective when you really need it

Stongly Agree

Agree

Disagree

Strongly Disagree

No Response

1% 13%

15%

15%

56%

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2. Q19. Generally medicines/treatments that I buy are less

effective

Stongly Agree

Agree

Disagree

Strongly Disagree

No Response

3%

18%

6% 29%

44%

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INFERENCE
Read the label Treat only the symptoms you have Know what to avoid while taking OTCs ASK before you buy Use as directed on the label Be careful if you take > 1 OTC Dont mix Rx and OTCs including herbals Give your doctor a list of ALL medicines For kids, use pediatric formulas Throw medicines away if they are expired
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Reference

Organization of Pharmaceutical Producers of India OTC article by vijay bhangle OTC marketing article by Ajith paninchukanath CIA World fact book www.google.com www.youtube.com

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A MESSAGE FROM US..

THANK YOU, by, Anand Ananth Anisha

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