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Otc in india
- 11. Source: ORG IMS analysis & estimates
- 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
- 15. % Self treaters, on a basis of 171 MN
Editor's Notes
- 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.