The Karnataka Drugs and Pharmaceutical Manufacturers Association (KDPMA) has expressed concern over the creation of a separate provision for over-the-counter (OTC) drugs, as it feels that the consumers in the country still require to be educated on the use and side-effects of OTC drugs. However, the Association has welcomed the government's proposal to create a separate category for OTC drugs.  

Responding to the government circular dated January 1, 2018 which invited comments on the creation of a separate provision for OTC drugs, KDPMA indicated that there is concern on the indiscriminate sale of OTC drugs.

The OTC drugs are generally those that are effective for minor ailments and extremely safe to use. Though these drugs are in vogue worldwide, we have to move with care with the OTC range because it could be randomly consumed and there is considerable need for awareness on its inherent side effects, stated KDPMA.

In the recent past, we have seen a lot of misuse of steroids for skin whitening which is a clear warning that we need to move with caution. We also need to upgrade the final point of sale as many drugs like multivitamins are sensitive to heat and light and hence maintaining proper conditions of sale will be essential, noted Sunil Attavar, president, KDPMA.

In it suggestions to the government, KDPMA said that as a first step OTC drugs can be made available without a prescription from pharmacies only. They should be only dispensed by a registered pharmacist who would also ensure that drugs are stored as per provisions of labelling.

India’s Pharmacovigilance programme needs to be upgraded 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 phased manner. For instance only the safest drugs should first be permitted under the OTC umbrella. This would also give the industry and government the much-needed experience, said KDPMA.

“If we look at sales from counters other than pharmacies, then care should be taken that its dispensing should be done only by a registered pharmacist. This will prevent misuse and also provide jobs 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 has to be adeptly controlled and hence, selling OTC with a well-structured bill must be made compulsory,” Attavar said.

The industry in Karnataka does see that it would be a challenge if the point-of-sale is not clearly defined. The labelling norms will need to be adequately 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 will need to be addressed, he added.

Chipping in its suggestion, the Association represented by the 70 members suggested that a category of drugs that may be included in the list of OTC drugs in a phased manner could be   nutraceuticals,  antacids, anti-flatulents, 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.