The Central Government initiative to amend the Schedule K of the Drugs and Cosmetics (D&C) Act and Rules and to allow sale of medicines categorized as household remedies in any shop across the country will have to face stiff opposition from the organized drug trade.
Reacting to the Pharmabiz news report on this, top-level office bearers of All India Organization of Chemists and Druggists (AIOCD) said the association would resort to extreme measures for stalling any move to allow sales of household remedies through any shops.
"This can lead to closure of many medical shops as stiff competition amongst themselves, competition from hospital pharmacies and low margins are already affecting the very survival of medical shops. If prescription drugs are allowed to be sold through any shops, then they may effectively work as medical shops and in turn the licensed medical shops will have no option but to close down" noted A N Mohan, president, AIOCD.
Sources said according to rough estimates, sale of household remedy category drugs are to the tune of over Rs.3000 crore in India. It accounts for 5-10 per cent of the drug sales through medical shops. Out of this, anti-pyretic and antacid drug sales alone contribute nearly Rs.250 crore each. Similarly, skin ointments and ointments for burns have sales of over Rs.250 crore. In 2005, the Indian OTC segment was estimated about Rs. 4500 crore, and it could be considered as Rs. 17000 cores if cosmeceuticals & neutraceuticals are also included, according to industry estimates.
Sources cited that sale of prescription drugs like paracetamol, aspirin combinations and other anti-pyretic drugs through any outlet is a dangerous proposition in a country like India having large uneducated population. In developed countries, where such OTC sales are allowed, patient interests are protected through insurance and they are educated enough to discern what to buy and at what dosage, they noted.
Interestingly, the move to allow sale of many popular and proven drugs through open shops stems from a recent initiative of major drug manufacturers, especially the Organization of Pharmaceutical Producers of India (OPPI), which initiated a campaign to make about 57 drugs as OTC. Recently the association submitted a list of 11 molecules including Ibuprofen, Mefenamic Acid salts, its esters, their Salts, Bromhexine Hydrochloride, Domperidone, Loperamide, Mebendazole, Diclofenac Sodium/Potassium acid, Prochloperazine, Naproxen Sodium and Ketoprofen, with safety data on these molecules to the DCGI. However, the Indian Drugs Manufacturers Association (IDMA) opposed this move.
As reported in Pharmabiz, the Drugs Technical Advisory Board (DTAB) has approved the amendment and the draft notification is expected any day. The medicines that come under the 'household remedy' category are Aspirin Tablets, Paraetamol tablets, Analgesic Balms, Antacid Preparations, Gripe Water for use of infants, Inhalers (containing drugs for treatment of cold and nasal congestion), Syrups, lozenges, pills and tablets for cough, Liniments for external use, Skin ointments and ointments for burns, Absorbent cotton wool, bandages absorbent gauze and adhesive plaster, Castor Oil, liquid Paraffin and Epsom Salt, Eucalyptus Oil, Tincture Iodine, Tincture Benzoin Co. and Mercurochrome (in containers not exceeding 100 ml), Tablets of Quinine Sulphate I.P. and tablets of Iodochlorohydroxy quinoline - 250 mg.