Separate Category of OTC Drugs to Increase Accessibility and Affordability

The All India Organization of Chemists and Druggists (AIOCD) has welcomed the government’s initiative to create separate category of over the counter (OTC) drugs to be sold in pharmacies, saying this move will help Prime Minister’s vision of improving availability and affordability of healthcare services including drugs to poor patients at affordable cost in the nook and corner of the country.

Globally, for drugs that can be sold over the counter, there is a separate category, but India lacks it. Once the OTC list is incorporated in Drugs and Cosmetics Act 1940 and Rules 1945, pharmacists will legally be permitted to dispense medicines to the patients.

This move will save patients botheration to visit the doctor for every common illness and help them to cut down on doctor’s consultation fees.

The expanded powers of the pharmacist will have several advantages, including increased convenience and accessibility for the individuals who require refills or have a minor illness.

It will help to manage a patient’s long-term care which will alleviate pressure on alleviating pressure and doctor’s clinics, said AIOCD in its submission to the panel set up by the government to look into categorisation of OTC drugs. The proposed system will provide Indian consumers access to a wide variety of OTC pharmaceuticals.

There is need to list OTC drugs in the separate schedule for transparency. Similar drugs can be sold without a prescription and all the more important, it would characterize which medicines can be sold over the counter, said AIOCD president J S Shinde.

At present, according to D&C Act 1940 and Rules 1945, drugs covered under Schedule H, Hl and X are required to be sold against the prescription of specialists as it were. Other drugs can be available to patients without doctor’s prescription.

People assume that drugs not in Schedule H, Hl, and X list don’t require a prescription. There is no absolute and transparent clarity on this issue to the common public.

At Present Rule 65 and 97 mandate prescription for plan H, Hl and X drugs and schedule G mandate medical supervision if drug contains a substance specified in Schedule G.

In this manner in accordance with US FDA, in larger public interest, AIOCD recommended that proposed OTC drugs should be categorized and labelled as follows: The ‘Uses’ section of the label of the product might contain ‘Indications’ that have been set up in an applicable OTC drugs or alternative truthful and not- misleading statements describing only those signs for use that have been established.

The label shall contain data such as the method of administration, and major contraindications (assuming any) should be a part of the data.

Pregnancy, nursing, geriatric, pediatric and so on use warnings (assuming any) should be a part of such data. Drug categories should be clearly specified and might cover the following designated categories:- antacids, laxatives, antidiarrheal, emetics, anti-emetics, antiperspirants, sunburn prevention, and treatment, vitamins – minerals, antimicrobial products, anti-dandruff products, oral hygiene aids, haemorrhoidal drugs, haematinics, bronchodilator and anti-asthmatics, analgesics, against pyretics, anti-sceptics, etc, sedatives and sleep aids, stimulants, antitussives, anti-allergic drugs, cold remedies, anti-rheumatics, ophthalmic preparations, contraceptive, miscellaneous derrnatologic products, dentifrices and dental products, miscellaneous (all other OTC drugs not falling within one of the above therapeutic categories), said the pharma trade body.

Pertinent medical and scientific literatures comprising documented case reports, expected or frequently reported side effects, safety and effectiveness of the drugs in an assigned category of OTC drugs, benefit-to-risk proportion of a drug, warnings against unsafe, side effects, and adverse reactions in such terms as to render them likely to be perused and understood by the common individual, under customary conditions of purchase should be accompanied as ‘Drugs Fact’ with all OTC products, concluded Shinde.


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