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Unregulated market of over the counter (OTC) drugs

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KATHMANDU, May 15: Over the counter (OTC) drugs are essentially those drugs that can be bought from pharmacies without the prescription of a health care professional. These drugs are approved by the Department of Drug Administration (DDA) as safe and effective for use in treating minor ailments without requiring a visit to the doctor. OTC drugs fall under DDA´s Group C drugs.



Group C drugs constitute a significant portion of Nepali drug industry estimated at around Rs 10 billion a year. "Nepali pharmaceutical companies enjoy around 40 percent of this market and about OTC drugs account for about 8-10 percent of the domestic drug market," said Umesh Rauniyar of Nepal Pharmaceuticals. [break]



According to a survey titled "Quantification of Drug Consumption in Nepal," carried out by DDA in 2004/05, Vitamins (6.1 percent), cough preparation (4.6 percent), IBU profine and paracetamol combination (3 percent), Iron and Folic Acid (2.4 percent) and Paracetamol (2.2 percent) are among the top selling OTC drugs. They alone accounted for 18.4 percent of the total drug consumed in 2004/05.



Because of OTC drugs, people are getting easy and fast treatment for minor ailments like cough, fever, diarrhea, without having to spend time and money on visiting a doctor. For people in rural areas this means a lot of money and time saved, since health facilities are often inaccessible and unaffordable. It also means that the pressure on medical services, which is insufficient in most cases, is reduced significantly.



Unfortunately, this is only the rosier part of the picture. Almost all the drugs, even prescription drugs that belong to Group A and B, are traded over the counter without prescription. "This is a matter of grave concern because pharmacists may not know the required strength of the drug, its dosage and duration," said Babha Rajbhandari of DDA.



Lack of proper dispensing of drugs can create unnecessary side-effects and may even cause death.



However, professionals and stakeholders in the pharmaceutical industry are ambivalent about regulating the unregulated OTC market. Their argument is that since Nepal lacks sufficient health professionals to meet the needs of the people, especially in the rural areas, trading prescription drugs over the counter becomes a necessity in most cases.



"This market is hard to regulate because there are around 20,000 pharmaceutical outlets in the country and DDA has only 10 to 15 inspectors," said Umesh Lal Shrestha, managing director of Quest Pharmaceuticals.



What they suggest is to have different policies for rural and urban areas. In the short run, DDA can be more liberal on its OTC policies in rural areas because they do not have alternative to purchasing OTC medicines.



The issue can only be mitigated by making health care more accessible and affordable. Also pharmacists in both rural and urban areas should be made aware that selling prescription drugs without a prescription is dangerous. Though DDA requires pharmacists to have a Bachelors or Diploma in Pharmacy, it has not been able to monitor this.



Stakeholders suggest DDA to make market monitoring strong. If the DDA punishes those pharmacies that sell prescription drugs without health professionals´ prescription, it will help discourage such practice, they added.



Another initiative all the stakeholders - DDA, Nepal Chemists and Druggists´ Association and Association of Pharmaceutical Producers´ of Nepal -- can take is to raise awareness among the people about the harmful side effects of taking prescription drug without prescription.



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