With the deadline for receiving comments on the draft amendment to the Schedule K of the Drugs and Cosmetics Act fast approaching, the supporters and opponents to the move are actively driving their views before the authorities. The amendment, which would allow the drugs categorized as 'household remedies' to be sold from unlicensed outlets throughout the country, is being strongly opposed by the drug traders lobby represented by All India Organisation of Chemists and Druggists. On the other hand, pharmaceutical manufacturers and some consumer organizations have welcomed the government decision.

The AIOCD has called the move as 'dangerous' that could pose serious health hazards to the consumer. The industry organizations and certain consumer organizations have said that the status of 'chemist outlets' in India is no better than 'grocery shops' and hence there cannot be any additional threat to human safety even if these medicines are made available in unlicensed outlets.

Rubbishing the allegations, AIOCD states that the health concern raised by them stems from the dangerous side effects of the medicines that have been proposed to be distributed through unlicensed outlets. According to A N Mohan, president AIOCD, the opposition is primarily because medicines like lodochlorohydrox quinoline, a drug that is not to be given to children below the age of 12, are included in the list. "Even commonly used paracetamol is not meant for unlimited use. It can cause side effects if used with certain other medicines. Same is the case with calcium preparations and the cough syrups. Who is to advice the customer if he intends to misuse cough syrup which gives drowsy effect in large quantities? Further, there cannot be any regulation on the quality of medicines that are supplied through unlicensed shops. We have already made two representations before the health ministry and, depending upon their response, would plan our future course of action," he said.

Countering the argument of pro-Schedule K amendment lobby, Mohan informed that the government should not adopt a model that is practiced in a developed country without studying Indian situations. "In developed countries where calcium preparations are allowed to be sold in general stores, there are specific laws that makes manufacturer accountable for the safety of the consumer. Laws like the Prescription Marketing Act, Anti-Tampering Act etc are all meant to give additional protection to the consumer. Here, it's all governed by a single Drugs and Cosmetics Act. And we have a very weak regulatory agency to enforce this law. One should understand the ground realities before allowing free sale of medicines through unlicensed outlets," he explained.

AIOCD has called for a meeting of all its state constituents on October 13 to discuss the future course of action. "We may even approach the court if the government moves ahead with its plan," Mohan hinted.

The consumer organizations however had a different view on the issue. Speaking at a recent interactive session, Bejon Misra, Immediate past chairman, consumer co-ordination council came down heavily upon the drug trade. According to him, chemists and druggists are behaving in an irresponsible manner and there is an urgent need to make medicines available through unlicensed outlets. "Chemists don't want to work for lower margins. We are working for developing co-operative medical shops to break the medicine trade cartel of the country," he said.

The OTC Committee of the Organisation of Pharmaceutical Producers of India (OPPI) also had a similar view. "There is a need for increasing access to commonly used household remedies so that people can easily purchase them to combat common and minor ailments when the need arises, rather than going to find a chemist shop", Bharat Patel, Chairman, OTC committee, OPPI said.

Dr C M Gulhati, Editor, Monthly Index of Medical Specialities (MIMS) was of the opinion that the proposed changes were long due and should be welcomed. He was however critical about the government decision to include lodochlorohydrox quinoline, a drug that is banned in most of the countries in the list of medicines that are to be made easily available through unlicensed shops.

As reported earlier, the amendment proposes 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 and 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.

It is estimated that 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.