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he All India Organisation 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 boost Prime Minister's vision of improving accessibility and affordability of healthcare services including drugs to ailing patients at affordable price in the nook and corner of the country.

Globally, there is a separate category for drugs that can be sold over the counter, but India lacks it. Once the OTC list is incorporated in Drugs and Cosmetics Act 1940 and Rules 1945, pharmacists will legally be allowed to dispense medicines to the patients. This move will save patients botheration to visit doctor for every common ailments and help them cut down on doctor's consultation fees. The expanded powers of pharmacist will have several advantages, including increased convenience and accessibility for those who need refills or have a minor illness. It will help to manage a patient's long-term care which will alleviate pressure on hospitals and doctor's clinics, said AIOCD in it 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 medicines. 

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

Currently, as per D&C Act 1940 and Rules 1945, drugs covered under Schedule H, Hl and X are required to be sold against the prescription of doctors only. Other drugs can be available to patients without doctor's prescription. People presume that drugs not in Schedule H, Hl, and X list do not 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 schedule H, Hl and X drugs and schedule G mandate medical supervision if drug contains a substance specified in Schedule G. 

At present there is no specific and categorical provision and information on non-prescription drugs labels to guide general public and pharmacist. 

Therefore in line with US FDA, in larger public interest, AIOCD suggested that proposed OTC drugs shall be categorized and labelled as follows: The 'Uses' section of the label of the product shall contain 'Indications' that have been established in an applicable OTC drugs or alternative truthful and non-misleading statements describing only those indications for use that have been established.

The advertisements (permitted if any) and or marketing of such products shall prescribe, recommend, or suggest its uses only under the conditions stated in the labelling so that there will not be any gross confusion amongst pharmacists, trader and public. Maximum daily dosage reasonably required to achieve its intended effect. The vague term for uses shall not be part of label of OTC drugs. e.g. you may ask or consult or contact doctor, 'Drowsiness may occur', etc. 

Label shall contain information such as method of administration, and major contraindications (if any) shall be a part of the information. Pregnancy, nursing, geriatric, pediatric etc. uses warnings (if any) shall be a part of such information. Drug categories shall be clearly mentioned and shall 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, anti-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.

In the United States, there are more than 80 classes of OTC drugs.

It further said that advisory review panel shall be established to look into classification of OTC drugs. The members of a panel shall be qualified experts, doctors, consumers, and representation from pharmaceutical industry and pharmaceutical trade organisation. 

Pertinent medical and scientific literatures comprising documented case reports, expected or frequently reported side effects, safety and effectiveness of the drugs in a designated category of OTC drugs, benefit-to-risk ratio of a drug, warnings against unsafe use, side effects, and adverse reactions in such terms as to render them likely to be read and understood by the ordinary individual, under customary conditions of purchase shall be accompanied as 'Drugs Fact' with all OTC products, concluded Shinde.