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Otc in india

A study of the Over The Counter Drug Market in India.

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Otc in india

  1. 1. rahul.gulrajani
  2. 2. <ul><li>‘ OTC drugs’ means drugs legally allowed to be sold ‘over the counter’ by pharmacists </li></ul><ul><li>they do not require the prescription of a Registered Medical Practitioner </li></ul><ul><li>the phrase ‘OTC’ has no legal recognition in India, but all the drugs not included in the list of ‘prescription-only drugs’ are considered to be non-prescription drugs (or OTC drugs) </li></ul>
  3. 3. <ul><li>prescription-only drugs are those medicines that are listed in Schedules H and X of the Drug and Cosmetics Rules </li></ul><ul><li>drugs listed in Schedule G (mostly antihistamines) do not need prescription to purchase but require the following mandatory text on the label: “Caution: It is dangerous to take this preparation except under medical supervision.” </li></ul><ul><li>drugs falling in these three schedules are currently not advertised directly to the public under a voluntary commitment by the pharmaceutical industry </li></ul>
  4. 4. <ul><li>today, many brands have reached a stagnation as far as prescription growth is concerned owing to emergence of newer therapies for the same ailment and high incidence of repeat purchase / chemist push </li></ul><ul><li>at the same time, legalities or internal policies may not permit direct communication of the brand to the patients </li></ul><ul><li>hence, clients resort to trade incentives / loading / schemes, and loyalty programs for doctors </li></ul>
  5. 6. <ul><li>doctors feel serious medicines require medical supervision & should not be advertised OTC </li></ul><ul><li>OTC medicines are acceptable in non-serious ailments and are cited to be favoured because of ease of availability </li></ul><ul><li>doctors are perfectly okay with the idea of OTC products being promoted to them </li></ul><ul><li>however, concerns are expressed with respect to medicine abuse and they feel that chemist should play the role of an advocate in guiding patients while recommending OTC medicines </li></ul>
  6. 9. <ul><li>India currently ranks 11 th in the global OTC market size </li></ul><ul><li>it is estimated that it will reach 9 th position within five years </li></ul><ul><li>in 2009, the Indian OTC market was approximately USD 1.8 BN with CAGR 0f nearly 10% </li></ul><ul><li>typical OTC products include digestives, antacids, antiflatulents, cold rubs and analgesic balms/creams, vitamins/tonics/health supplements, medicated skin treatment, analgesic /cold tablets, antiseptic creams/liquids, glucose powders, cough liquids, throat lozenges, medicated dressings (band-aids), baby gripe water, Ayurvedic medicines and preparations </li></ul>
  7. 10. <ul><li>Source: Nicholas Hall & Company, India, DB6 2009 – 1US$ = INR.46.54 </li></ul>
  8. 11. Source: ORG IMS analysis & estimates
  9. 12. <ul><li>the OTC market in India would show growth rates between 10-12% over next 5 years </li></ul>
  10. 14. low amongst consumers high amongst consumers low amongst doctors high amongst doctors Current OTC products Headaches/Bodyaches, Cold, Cough and Fever Unfavourable Skin diseases, BP problems, Viral/Bacterial infections, Diabetes Current OTC products Acidity, indigestion, Nausea Unfavourable Overall weakness Potential Growth Muscle Sprains/Pain, Cuts and Burns, Loose Motion/Constipation, Pimples
  11. 15. % Self treaters, on a basis of 171 MN
  12. 16. <ul><li>almost half of the consumers go directly to a chemist at the first signs of any ailment </li></ul><ul><li>as many consumers (almost 1/4 th ) self-medicate as those who go directly to a doctor at the outset </li></ul><ul><li>strong faith in home remedies </li></ul>
  13. 17. <ul><li>advice from retailer is taken, considering lesser severity of the ailment & high cost of visiting a doctor </li></ul>
  14. 18. <ul><li>Source: Nicholas Hall & Company, India </li></ul>
  15. 19. <ul><li>increasing consumer confidence in OTC for common ailments </li></ul><ul><li>– 70 % self medication in these categories </li></ul><ul><li>– 45 % influenced by chemist </li></ul><ul><li>natural is better ,a strong belief in Indian homes </li></ul><ul><li>– more than 30% of the time consumers use home remedies </li></ul><ul><li>– major usage of home remedies found in cough, cold, heartburn and indigestion categories </li></ul>
  16. 20. <ul><li>doctors favour time tested, trusted OTC products used in common ailments </li></ul><ul><li>doctors would like to be active mediators where possible </li></ul><ul><li>– simultaneous communication to doctors essential </li></ul><ul><li>many ignored categories ripe for OTC products </li></ul><ul><li>– emerging categories include cuts & wounds , burns, muscle pains & strains, diarrhoea, constipation </li></ul><ul><li>doctors not much involved in vitamin prescriptions, but consumers not knowledgeable to take the OTC decision </li></ul><ul><li>– significant vacancy in vitamin supplements </li></ul>
  17. 21. <ul><li>the major legislation for pharmaceutical regulation is the Drugs and Cosmetics Act, 1940 (DCA) and its subordinate legislation, the Drugs and Cosmetics Rules,1945 (DCR) </li></ul><ul><li>the legislations apply to the whole of India and to all categories of medicines (e.g., allopathic, ayurvedic, siddha, unani and homeopathy), whether imported or manufactured in India </li></ul><ul><li>the legislation is regulated by the Central Government ( Ministry of Health & Family Welfare) in New Delhi, which is responsible for its overall supervision and enforced by State Government through its Food and Drug Administration (FDA) </li></ul><ul><li>power to provide manufacturing and selling licences - which are the two main stages required to manufacture and sell a drug - belongs to each individual State Government through its Food and Drug Administration (FDA), which also carry out enforcement of the DCA and the DCR </li></ul>
  18. 22. <ul><li>price controls are exercised on certain drugs by virtue of the Drugs (Prices Control) Order 1995 (DPCO), in the framework of the Essential Commodities Act (ECA) </li></ul><ul><li>the DPCO is the responsibility of the Ministry of Chemicals and Fertilisers and is supervised by the National Pharmaceutical Pricing Authority (NPPA) </li></ul><ul><li>only a few OTC actives, e.g. acetylsalicylic acid and ephedrine and its salts, fall under the current DPCO price control </li></ul><ul><li>there are no price controls on ‘Ayurvedic Medicines’ </li></ul><ul><li>prices of non-scheduled drugs are subject to a maximum increase of 10% on the prevailing price over a 12-month period </li></ul>

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A study of the Over The Counter Drug Market in India.


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