KDPMA about OTC drugs:
The Karnataka Drugs and Pharmaceutical Manufacturers Association (KDPMA) has expressed concern over the making of a separate provision for over-the-counter (OTC) drugs, as it feels that the consumers in the country still require being instructed on the use and side-effects of OTC drugs.
Notwithstanding, the Association has welcomed the government’s proposal to create a separate category for OTC medications.
Responding to the government circular dated January 1, 2018, which welcomed remarks on the production of a separate provision for OTC drugs, KDPMA demonstrated that there is a concern about the indiscriminate sale of OTC drugs.
The OTC drugs are for the most part those that are effective for minor ailments and extremely safe to use.
KDPMA stated, In spite of the fact that these drugs are in vogue around the world, we need to move with care with the OTC range since it could be randomly consumed and there is a considerable requirement for awareness on its inherent side effect. In the recent past, we have seen a lot of abuse of steroids for skin brightening which is a clear warning that we have to move with the alert.
Sunil Attavar, president, KDPMA noted, We also need to upgrade the final point of sale as many drugs like multivitamins are sensitive to heat and light and subsequently keeping up appropriate conditions of sale will be essential.
First Step for OTC Drugs:
In its proposals to the government, KDPMA said that as an initial step OTC drugs can be made available without a prescription from pharmacies only. They should be only dispensed by a registered pharmacist who might also ensure that drugs are stored according to provisions of labeling.
KDPMA said India’s Pharmacovigilance program should be moved up to allow consumers to log-in to know about the adverse drug action or to report the same to the pharmacy outlets. The launch of these OTC drugs can be in a phased way. For example, only the safest drugs should first be allowed under the OTC category. This would also give the industry and government the truly necessary experience.
Attavar said, “If we look at counters other than pharmacies, at that point care should be taken that its dispensing should be done only by a registered pharmacist. This will prevent abuse and furthermore provide employment to the numerous fresh pharmacy graduates. Since all other provisions of the D&C Act will still apply, recall in case of any adverse action or failure must be proficiently controlled and hence, selling OTC with structured bill must be made necessary”.
Labeling Standards for Consumers:
The industry in Karnataka sees that it would be a challenge if the point-of-sale isn’t clearly characterized. The labeling standards should be sufficiently revised to make it easier for consumers to read and understand its contents.
The issue of similar sounding brand names, with different drugs, is an apprehension and should be tended to, he included.
Chipping in its proposal, the Association spoke to by the 70 individuals recommended that a category of drugs that might be included into the list of OTC drugs in a phased way could be nutraceuticals, antacids, anti-flatulent, calamine lotion and similar products, expectorants, cough suppressants, decongestants, analgesics, antiseptics, anti-histamines, dental products, topical anti-fungal drugs, anti-acne drugs, anti-haemorrhoids and smoking cessation drugs.