B.Gitanjali & K.Weerasuriya Scheduling OTC Medicines to Empower the Consumer: Challenges and Opportunities B.Gitanjali & K.Weerasuriya

When choosing a non-prescription medicine what factors are most important to you? The Nielsen Global Online Consumer Survey, conducted by Nielsen Customized Research, was conducted in April 2008 among 28,153 internet users in 51 markets from Europe, Asia Pacific, North America and the Middle East.

This talk is about scheduling OTC drugs to enhance access to consumers of simple medicines for common minor conditions

Even prescription only medicines are available in pharmacies without a prescription. So why should we bother about the OTC drugs? It is illegal It is in the interest of the consumers and other stake holders to have a legally recognized schedule to promote access

What are the issues pertaining to OTC drugs in India? The term has no legal recognition. There is no list of OTC drugs. All drugs that are not ‘prescription only’ are OTC All drugs should be sold only in licensed shops, even the OTC drugs

Exception to the rule Schedule K of the Drug Control Rules (1945) Shops without a license can sell drugs known as household remedies In villages with a population of less than one thousand

Simple scheduling with simple rules will be beneficial to all Perhaps we could call them ‘non-prescription drugs’ and not OTC Do we need to bother with all this?

Example No.1 – man goes to a pharmacist Hmmm..Good chance to rip him off… I am having fever and body ache since last night. Please give me some medicine You can take this “new medicine” for fever… a bit costly but it is good. I am also giving you an antibiotic…just in case there are some germs…take one vitamin injection first to help you get better quickly…

Example No.2 – man treats himself I am having fever and body ache since last night. What should I do? I will take a tablet of Crocin and see if I feel better. In case the fever persists or I get worse, I will go and see a doctor. …

Guide consumer behaviour towards responsible self medication… Guide consumer behaviour towards responsible self medication…

What are the medicines that should be sold as OTC? Pain killers, antipyretics, cough and cold medicines, medicines for allergy, ORS, antiseptics for cuts and burns, medicines for heart burn, constipation, vitamins and minerals, topical agents for aches and sprains…

Like the OTC drugs another schedule - the ‘Pharmacy only’ drugs…. Would be limited to pharmacies but sold without a prescription, as the pharmacist is competent enough to prescribe them. e.g. mebendazole, oral contraceptive, omeprazole There could be gradations in the scheduling of these non-prescription drugs.

What would scheduling entail? Can be sold at all shops Advertised under brand names With appropriate information Sold in original wrapping

OTC in India “Maximum number of OTC drugs sold by qualified chemists and pharmacists are from branded companies like Pfizer Inc., share of which is estimated at about 8%, followed by Sanofi-Aventis 7% and Johnson & Johnson 5.5%..” -Assocham study, 2008. The Associated Chambers of Commerce and Industry of India (ASSOCHAM)

What are potential problems? Excessive advertising Generic name may not be seen in all advertisements Patients may take these medicines for too long or take too high a dose

Misuse of OTC drugs causes 1,78,000 hospitalizations a year

" Take a pill as soon as you know that things have gone wrong " Take a pill as soon as you know that things have gone wrong. And you can prevent an unplanned pregnancy. That's it. And do be little careful the next time. Now there goes the alarm. Switch it off and begin a new day…

To sum up… Scheduling OTC drugs will empower the consumer The regulations should be enforced Advertising should be monitored