A Schedule For OTC Drugs: NK Ahooja

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Last Updated on October 19, 2019 by The Health Master

A sub-committee, constituted by the Union Health Ministry to define the Over-the-Counter (OTC) drugs, has recommended to the government to classify the OTC drugs into two separate categories – one for those drugs that can be sold in retail outlets and the second category for those drugs that can be sold under the supervision of a registered pharmacist. The three-member sub-committee, under the chairmanship of Haryana state drugs controller N.K. Ahooja, has come to the conclusion that there is an urgent need to define the OTC drugs and to lay down specific provisions for the regulation of OTC drugs in the country. The committee recommended to the government to promote self-care without compromising patient safety thereby reducing the treatment cost of the common people. The panel asked the government to classify OTC drugs into OTC-1 and OTC-2 categories based on the extent of evidence of safety, therapeutic index, need for accessibility to patients, availability, non-habit forming nature, present supply chain mechanism and socioeconomic conditions of the country. Even though a separate category of OTC drugs is common in many countries, including several developing and developed countries, in India all the allopathic drugs including the drugs which are considered safe to be dispensed without prescription also fall under Schedule H and H1. As per D&C Act 1940 and Rules 1945, these drugs should be sold against prescription only. Because of these provisions, the patients with even common ailments were forced to consult a physician for treatment. 

Now, the expert panel has made some sweeping recommendations to the government which will definitely improve accessibility and affordability of healthcare in the country, especially to the poor patients who reside in the remote areas. Its recommendation to introduce a properly sized ‘unit dose packaging’ for non-prescription drugs will go a long way in eliminating the possibility of misuse or overdose of medicines by the common people, especially those reside in the remote areas and villages. This will be all the more important for a country like India where a considerable percentage of people is still illiterate. Once the government implements the recommendations, such customised dose pack of medicines for common ailments such as cough, cold, flu, etc will be available even at the local grocery shops in the length and breadth of the country. Such provisions will prove to be a boon for a large section of people in the country, who are still not in a position to bear the cost of treatment and the doctor’s fee. The panel also deserves kudos for recommending ‘adequate labeling’ for all the OTC drugs as that will help the consumers to self-diagnose, self-elect, self-administer and know when to stop using medicines. Of course, there was a dire need to create a robust regulatory framework for OTC medicines in the country by incorporating a separate schedule in the Drugs and Cosmetics Act. Once the government implements the proposals of the panel, the patients will have no botheration of visiting doctors for treating common ailments as a qualified pharmacist will then be empowered to dispense OTC drugs for common ailments.