After sitting over the proposal seeking to expand the over-the-counter (OTC) drugs list amid differences in the industry, the authorities have finally ruled out any change or revision of the list. However, pending amendment to Schedule K to exclude Aspirin and Quinine Sulphate IP from the list of household remedies may come through with a final notification in this regard.
Though there was a proposal to place before the Drugs Technical Advisory Board (DTAB) the issue of expanding the OTC drugs list as demanded by some sections of the industry, it is learnt that the DCGI is against disturbing the present list now. The issue, which was subject of intense debate in the industry, thus seems to be a closed chapter, sources indicated.
Some companies have been pressing to revise the list to include more categories of drugs in view of the changed pharma scenario and more awareness among the consumers. However, the authorities feel that the situation was still considerably different from the West where popular drugs are allowed to be sold by super market players having proper storage facilities. The All India Organisation of Chemists and Druggists (AIOCD) had been opposing the move strongly while some leading manufacturers and consumer organisations supported it.
However, the amendment to Schedule K to exclude Aspirin and Quinine Sulphate IP from the list of household remedies, which has been pending since August 2006, may get a fresh look and be cleared. The amendment also seeks to do away with the restriction that limits sale of household remedies from unlicensed premises to villages having no licensed outlet and having a population less than 1000.
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. As per a conservative estimate, the sale of household remedy category drugs accounted for 5-10 per cent of the drug sales through medical shops.