The Indian Pharmaceutical Association has recommended to the Union government that the country immediately needs an over-the-counter (OTC) list of drugs. A detailed information list of medicines rather than catalogue of all categories should be displayed on the websites of CDSCO, state drugs controllers, MoHFW and Consumers Affairs ministry website.
In its suggestions to the government, on the separate provisions for OTC, the Association pointed out that currently such a category does not exist in India and the categorisation of medicines in India is not transparent.
Globally, clear cut guidelines exist for OTC and with none in India there is considerable ambiguity across stakeholders including drug regulators, pharmacists, public and doctors. Further, there are international norms laid down for prescription to OTC and OTC to prescription switches. Now India has no such guidelines. Instead pharmacists face the criticism that they dispense drugs without a prescription.
Whilst it is essential that many medicines need to be dispensed against a prescription, there are many drugs which may be dispensed under the supervision and wisdom of a pharmacists without a prescription. However, in India, many such medicines fall under the prescription category. Therefore it is essential to re-examine the whole issue and re-categorise medicines in a manner based on scientific principles, patient safety but a the same time considering the prevailing circumstances in the country.
“Our suggestion is that OTC medicines need to be defined under the D&C Act and given a legal status. There is a need for two dedicated lists. One for single ingredient OTCs and the other for fixed dose combinations (FDCs),” stated Kaushik Desai, Hon. Secretary, Indian Pharmaceutical Association.
In addition, the Association also sees the need for another two categories of OTC medicines. These are non prescription drugs and general sales medicines which could be sold through outlets other than registered pharmacies. The former includes paracetamol, aspirin, antacids, topical preparations, NSAIDs like Ibuprofen, diclofenac, cetirizine, albendazole, mebendazole, povidone Iodine preparations apart from normal saline nasal drops and drugs under Schedule K like Dettol, Savlon and Band-Aid etc.
There should also be restrictions and guidelines on advertisement for OTC. The DTCA or direct to consumer advertisements should be permitted only for those drugs which are specifically listed out by the government, stated Desai.
Further the Association also sees that in order to prevent misinterpretations, guidelines for handling such medicines which are the non-prescription OTC drugs which need to be sold only through pharmacies and can be stocked only after seeking license for the same. Such medicines can be displayed at the outlets to the public but must be out of reach for them. This category of drugs need to be dispensed only against a prescription of a registered medical practitioner (RMP). The quantity of medicines to be dispensed should be specified under the Drugs and Cosmetics Rules for every product.
With reference to labels, the Association said a clear specification on package for OTC drugs with a green vertical line of 1mm thickness and a symbol indicating that it could be sold only by a pharmacist is mandated. Every medicine pack should contain Patient Product Information or Insert (PPI) and also indicate the Drug Facts like warnings and dosage among others. Even the Ayush drugs should be under the prescription category and dispensed with prescription only by pharmacists.