Amid growing differences in the pharma industry over the OTC drug list, the Drugs Technical Advisory Board (DTAB) is meeting here next month to consider the revision of the OTC drugs list. Though there are some other key topics forwarded by the recent Drugs Consultative Committee meeting, the major focus of the meeting will be the revision of OTC drug list.
The deliberations on the draft amendment to the Schedule K of the Drugs and Cosmetics Act will be one of the key points in the agenda for the meeting slated for next month, following the recommendations of the DCC, sources said.
This comes also in the wake of the mounting pressure by the MNC drug companies for permitting OTC sales of more categories of drugs that are apparently considered household remedies.
The DTAB had rejected a similar demand by the companies to expand the existing list of OTC drugs a few years back on the plea that the medicine-retailing scenario in India was considerably different from that of the West where popular drugs are allowed to be sold over the counter by super market players having proper storage facilities.
However, drug traders represented by All India Organisation of Chemists and Druggists have opposed the move while some manufacturers and consumer organisations welcomed it.
The Government had notified the draft amendment in August 2006. The amendment proposed to exclude Aspirin and Quinine Sulphate IP from the list of household remedies that can be sold from unlicensed outlets. It will also do away with the restriction that limits sale of household remedies from unlicensed premises to villages having no licensed outlet that has 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.
Due to the differences in the industry, the amendment was shelved and the Health Ministry asked the DTAB to consider it again. Thus the issue is once again before the elite body, even efforts were on by those opposing it and supporting it to mount larger pressure.
As per a conservative estimate, the sale of household remedy category drugs is 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 in the category, according to industry estimates.