The central government has proposed the exclusion of Aspirin and Quinine Sulphate IP from the list of household remedies that can be sold from unlicensed outlets. The changes are part of the draft notification that amended Schedule K of the Drugs and Cosmetics (D&C) Act to do away with the restriction that limits sale of household remedies from unlicensed premises to villages having no licensed outlet and has a population less than 1000.

While the decision to remove Aspirin from Schedule K list is likely to be welcomed by the pharma trade, the proposal for removing restriction clause for sale of medicine through unlicensed outlets will be strongly opposed by them. Aspirin is to become an OTC drug that can be sold through licensed outlets without prescription.

As per the draft notification issued on August 10, 2006, household remedies can be sold from any unlicensed trade outlet of the country. The medicines that continue to be under the 'household remedy' category include Paracetamol tablets, Analgesic Balms, Antacid Preparations, Calcium preparations with or without Vitamin D, Gripe Water for use of infants, Inhalers (containing drugs for treatment of cold and nasal congestion), Syrups, lozenges, pills and tablets for cough, cold or sore throat, 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), and tablets of Iodochlorohydroxy quinoline 250 mg, Medicated dressings and bandages for first aid etc.

However, these drugs should not contain any substance specified in Schedules G, H or X of D&C Act and Rules. The shopkeepers are also to ensure that the drugs are sold in the original unopened containers of the licensed manufacturers.

As reported earlier, the 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 and neutraceuticals are also included, according to industry estimates.

The draft rules will be considered for finalization after 45 days from the date on which the copies of the official gazette are made available to public. Considering the fact that the notification had reached sale outlets on August 14, the suggestions and complaints will have to reach the authorities by September end.