Even as the Union Health Ministry is bringing in an e-portal system for monitoring sale of drugs and licensing of online pharmacy, pharmacy experts are calling for a sustained pro-pharmacist intervention by the government to enable dispensing of drugs under prescription and non-prescription categories.
Except India, in all the countries in the world it is the discretion of the pharmacists to dispense OTC medicines to the patients without prescription by a registered medical practitioner.
In India the drug laws do not distinguish the category of Over-the-Counter (OTC) drugs from prescription categories. While generic prescription becomes legally binding, classification and enlistment of OTC drugs is necessary for the discretion of the pharmacists to dispense certain non-scheduled drugs over their counters. This classification is helpful for pharmacists as well as the patients. Further this will discard all the chances of complaints for dispensing OTC drugs without doctors’ prescriptions.
“The term OTC drugs is a loose and legally undefined term. It does not find a mention in the Drugs and Cosmetics Act, 1940, or in the Drugs and Cosmetics Rules, 1945. The Central Drugs Standard Control Organisation (CDSCO), under the second UPA government regime, had appointed a sub-committee to study, classify and enlist the OTC products and suggest measures for their regulations by central and state agencies. After a long period of home-work, the committee submitted its report to the central government in 2012. But no action has been taken on the committee’s report so far. At a time when the union government is introducing so many regulatory mechanisms for medicine sales, the proposal made by the sub-committee five years ago now needs attention”, said Dr. K.G Revikumar, a pharmacy expert from Kerala.
In the drug laws of foreign countries, everywhere there is mention about non-prescription drugs and those laws empower the pharmacists to dispense them to the patients without prescription of doctors. Since there is no mention about OTCs in Indian drugs laws, pharmacists are not empowered to sell such products to patients on their discretion. Classification and enlisting of non-prescription medicines are needed for a foolproof drug act. For this, the term OTC has to be defined and incorporated in the act. Further the enlisted names should be notified in the gazette, he maintained.
Dr Revikumar said, the United States Department of Food and Drug Administration (US FDA) defines OTC drugs as ‘drugs that are safe and effective for use by the general public without seeking treatment by a health professional’. In the backdrop of this, a definition has to be made in India also. Once it is defined and classified, the pharmacists can separate such products from the scheduled ones and keep them singly.
Medicinal products of vitamins, minerals, analgesics, certain categories of anti-inflammatory drugs and anti-pyretic drugs which are less toxic and generally used for common ailments are coming under OTC products. Dr. Revikumar said about 200 types of medicines were specified by the committee to be included in the list of OTCs.
With the introduction of Pharmacy Practice Regulations 2015, the pharmacists are empowered to provide counseling to patients on drug use. So, once the OTCs are notified through gazette, pharmacists can dispense OTC products to the patients for simple ailments without consulting a doctor.
Dr Revikumar has sent a letter to the Prime Minister, with a copy to the health minister, requesting him to consider the earlier report of the constituted committee with regard to enlisting and notification of OTC drugs.