Otc in india


Published on

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

Published in: Business, Health & Medicine
No Downloads
Total views
On SlideShare
From Embeds
Number of Embeds
Embeds 0
No embeds

No notes for slide
  • In India, the import, manufacture, distribution and sale of drugs and cosmetics are regulated by the Drugs and Cosmetics Act, 1940 (DCA), the Drugs and Cosmetics Rules, 1945 (DCR). Over the counter drugs may also be prescribed. Usually paid for directly by the consumer but, when prescribed, OTC medicines are sometimes covered by public and private drug plans overseas. Only a small number of OTC drugs are patented.
  • Prescription drugs are usually prescribed by a physician, dispensed by a pharmacist and received either in hospital or in the community. A prescription drug may or may not be patented. Currently, non drug-licensed stores (e.g. non-pharmacists) can sell a few medicines classified as ‘ Household Remedies’ listed in Schedule K of the D&C Rules in villages whose population is below 1 000 subject to certain other conditions. OTC drugs registered as ‘Ayurvedic Medicines’ (i.e. traditional Indian system of medicines containing natural / herbal ingredients) are also regulated by the DCA and DCR. Ayurvedic drugs are manufactured under a manufacturing licence issued by the Ayurvedic State Licensing Authorities. However, they do not require a drug sale licence and can be sold freely by non chemists. Some of the largest OTC brands in India are registered as ‘Ayurvedic Medicines’ because of their plant-based natural active ingredients (e.g. Vicks VapoRub, Amrutanjan Pain Balm, Zandu Pain Balm, Iodex Pain Balm, Moov Pain Cream, Itch Guard Cream, Eno Fruit Salt antacid, Vicks Cough Drops, Halls Lozenges, Dabur’s Pudin Hara etc.).
  • There is a need for Responsible self medication. Source: Nicholas Hall & Company, India
  • India is the 3 rd largest OTC market, after Japan and China. Source: IMS – Consumer Health’s OTC Review Plus, published in OTC Bulleting 17 Dec 2007. Estimated figures at manufacturers’ selling prices.
  • The OTC market is comprised of forward integrated Pharmaceutical companies and Backward integrated FMCG companies. The pharma firms are focused on prescription brands and think prescription business is more predictable and profitable, with their management more comfortable with RX capabilities. The FMCG companies are focused more on their FMCG portfolio which gives higher volumes, think that OTC means Ayurvedic, with capabilities on mass production. Zandu Pharmaceutical Works (now Emami), Cipla, Dabur India, Nicholas Piramal India and Ranbaxy Laboratories control nearly 51 percent of the total market. Zandu manufacturers about 300 Ayurvedic drugs and is a leader in the Indian balm and rub segment. Dabur India offers a wide range of products in the healthcare and personal care segments with exports to around 50 countries. Other leading players include Proctor & Gamble, Pfizer, Himalaya Drug Company, Paras Pharmaceuticals, Novartis, Alembic and GlaxoSmithKline.
  • Source: ORG IMS analysis & estimates
  • Source: ORG IMS analysis & estimates
  • Pains/sprains, cuts and burns, diarrhoea, constipation and acne are potential OTC areas in the years to come. General weakness category enjoys a high suitability at Medical Professionals but not so much at consumer, indicating poor awareness.
  • Source: ACNielsen OTC Syndicated Study
  • Hence, consumer dependence on retail pharmacies is high as retailer plays an advisory role. Consumers emerged more likely to self medicate in headaches, acidity/indigestion, possibly due to familiarity with brand & availability of home remedies in this category. Other ailments like loose motions, cuts & wounds, and vomiting also have high retail influence. Source: Nicholas Hall & Company, India
  • Source: Nicholas Hall & Company, India
  • Source: Nicholas Hall & Company, India
  • Source: Nicholas Hall & Company, India
  • Drug (Prices Control) Order, 1995, Drugs (Magic Remedies) Objectionable Advertisement Act, 1954 and Pharmacy Act, 1948 are other regulations which have a bearing on the pharmaceutical business in India. The office of the Drugs Controller General of India (DCGI) has the primary responsibility for approving new drugs, molecules and standards, Vaccines & Sera, new usage and claims, new method of administration, clinical research and trials, introductions of a new unique formulation and granting import and export licences. It oversees the activities of the Central Drugs Standard Control Organization (CDSCO). The DCGI also exercises control over medical devices imported or manufactured in India.
  • DPCO outlines the classification of price-controlled products and methods of price fixation and revision. The NPPA monitors drug prices by fixing and revising them. The 347 price-controlled drugs under the Drugs (Prices Control) Order 1979 were brought down to 143 in the Drugs (Prices Control) Order 1987. Under the DPCO-1995, there are 74 bulk drugs and their formulations under price control (known as scheduled drugs) covering significant percentage of the total pharmaceutical market in India. The price of scheduled drug fixed by NPPA is revised from time to time. The manufacturer is not allowed to increase retail price of scheduled drugs without approval of NPPA. However, prices of non-scheduled drugs are fixed by the manufacturer subject to a maximum increase of 10% on the prevailing price over a 12-month period.
  • 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>