The Indian Drugs Manufacturers Association (IDMA) has opposed the Organisation of Pharmaceutical Producers of India (OPPI) initiative to make a select list of prescription medicines as Over the Counter (OTC) drugs.

With the opposition from the industry itself, the OPPI move to get 11 select molecules excluded from Schedule H is likely to be fizzled out. OPPI had submitted its list and safety data of 11 molecules to the DCGI recently.

IDMA is of the view that minimum of products should be sold as OTC as India do not have the required infrastructure as well as qualified pharmacists. Even the literate and educated consumers of medicines are extremely few in numbers and hence it is all the more necessary to be extremely conscious while prescribing medicines to the patients in India.

In a draft proposal on the issue submitted by the association to the DCGI, it noted that OTC products must be primarily safe. They should never have been known to cause frightening side effects, must be relatively safe in overdose and also for the pregnant lady, nursing woman and small children. Besides these medicines are best stored in chemists’ shelves since the Indian general stores and those in shopping malls and plazas are not geared for such OTC product handling, which defeats the very purpose of shifting more products to the OTC category.

If availability is to be continued at chemists shops, it must be the prerogative of medical profession to dictate the use of the medicines under question. Doctors know fully well their possible side effect, and are knowledgeable about the OTC drugs potential to cause an array of side types. Hence they are best placed to judge the situations under which individual medicines must be avoided and to tackle all patient’s query.

IDMA noted that there is no need to shift four to five NSAID’s to OTC when paracetamol is available as OTC for similar use. In the case of some drugs for diarrheas, options such as ORS are recommended as first line of defence and hence there is need for OTC drugs. In cough and cold segment, instead of bromhexine, suitable cough cold formula is already advertised. Even adhatoda vasica, from which bromhexine is derived, is available as OTC. Prochloroperazine should not be made OTC as already there are suitable options to manage the various causes of vomiting such as antacids for gastritis-associated vomiting. The authorities should stick to their earlier stand against including more drugs in the OTC segment, especially if suitable and safe alternatives for that indication already exists, opined IDMA.

As reported in Pharmabiz earlier, the OPPI list of 11 molecules include Ibuprofen, Mefenamic Acid salts, its esters, their Salts, Bromhexine Hydrochloride, Domperidone, Loperamide, Mebendazole, Diclofenac Sodium/Potassium acid, Prochloperazine, Naproxen Sodium and Ketoprofen. OPPI contends that these molecules, currently in the prescription category, have a good safety profile and are having non- prescription status in many parts of the world. The list was published as part of an OPPI campaign to make some popular molecules in the category of cough and cold drugs, antacids, laxatives, topical creams against fungal and bacterial infections etc. as OTC drugs to boost its sales.

OPPI contends that about 570 molecules are under the prescription basket in India. As per the statistics, only 0.6 per cent of doctors are available for every 1000 people in the country. Doctors, especially those working in rural areas, are struggling to devote more time for their patients. If at least a few molecules in the cough and cold and pain management segment are made OTC, it could make big difference in reducing the workload of doctors. The current OTC basket in the country is only about 10 per cent of the domestic drug sales. Pain management and cough - cold segment is valued about Rs 400 crore. A liberal OTC environment would catapult sales of drugs in these segments, opine OPPI.