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Above THE COUNTER Drugs INDIA’S Perspective

Dr. Dimbeswar Das, M.D.,F.I.D.
ILS Hospitals, Agartala

February 13, 2023, 09:27:43   


Over-the-counter (OTC) medications are medications you can get with out a prescription. In the United States, the Meals and Drug Administration decides regardless of whether a drugs is safe and efficient adequate to sell over-the-counter. This permits you to choose a much more energetic purpose in your health and fitness treatment. But, the observe is not uniform throughout the world. There are distinctions in human actions,amount of consciousness and skill to understand the mechanism of action of diverse molecules, it is side outcomes profile etc., and most importantly,administrative control on this kind of exercise.

In India, deficiency of recognition of widespread folks about diverse aspect of these practice is a powerful variable for escalating and uncontrolled OTC acquire of medicines like agony killer tablets, various antacids, anti-allergic tablets,cough and chilly medicine,anti-diarrhoeal,drugs for constipation, acid-suppressing preparations, diverse antibiotics, multi natural vitamins,strength booster and many others. 1 can validate the facts and will be equipped to fully grasp the depth of this make a difference observing  the factors going on in the vicinity of the dispensing and billing counter of a pharmacy for some time and realise the way we are receiving exposed to the threats related  to this sort of apply.

Dangers to getting OTC medicines:

Food stuff and Drug Administration of Usa states that:

•The medicine you are getting could interact with other medicines, nutritional supplements, foods, or beverages

•Some medications are not appropriate for people with selected health care circumstances. For instance, people today with significant blood force should not consider specific decongestants.

•Some people are allergic to selected medications

•Many medications are not safe for the duration of pregnancy. In circumstance of pregnancy, a single ought to look at with her wellbeing care service provider in advance of using any drugs.

•One must be careful when supplying medications to childrenand to make positive that the boy or girl is presented the appropriate dose. If you are supplying your baby a liquid medicine, will not use a kitchen area spoon. Alternatively use a measuring spoon or a dosing cup marked in teaspoons.

•you also want to be cautious to steer clear of errors. Make sure to follow the instructions on the drug label. If you never fully grasp the guidance, request your pharmacist or wellbeing treatment service provider.

•If you have been having an OTC medication but your indicators really don’t go absent, call your health care service provider. You really should not choose OTC medicines more time or in greater doses than the label recommends.

Regulation by region

Clients,specially in acquiring state like India, usually strategy a pharmacist rather of heading to seek advice from a doctor for minimal ailments such as cough, cold, allergic reactions, soreness, fever, acidity, diarrhea, and skin-similar disorders etcetera. Obtain of precise medications about the counter is lawfully identified in most international locations. ‘Over-the-Counter (OTC) Medicines’ implies medications which are lawfully permitted to be sold by pharmacists without having need to have for a appropriate doctor’s prescription. However,the phrase does not have a lawful definition in India. Technically, drugs are OTC until they are especially said as prescription only prescription drugs. OTC medicines certainly allow for faster and more affordable accessibility to health care but, their misuse and adverse effects cause concerns.

In a lot of nations, OTC drugs are selected by a regulatory agency to make sure that they include ingredients that are secure and successful when utilised without the need of a physician’s treatment. OTC prescription drugs are normally controlled as for every their lively pharmaceutical ingredient (API) instead than final solutions. By regulating APIs as a substitute of particular drug formulations, governments enable firms the flexibility to formulate components, or to incorporate substances, into proprietary mixtures.In November 2016, India’s Drug Consultative Committee declared that it was embarking on establishing a definition of medications which could be dispensed with no a prescription. But the authorized definition is not nevertheless entire and very clear.

Transitions among prescription and OTC:

Just one can comprehend, in excess of-the-counter medicine have to be made use of generally to deal with a situation that does not require the direct supervision of a health care provider and it is reasonably safe and sound and effectively tolerated.OTC medication are typically also required to have tiny or no abuse opportunity, despite the fact that in some locations drugs these as codeine ,getting dependancy potential, are accessible OTC (typically in strictly minimal formulations or necessitating paperwork or identification to be submitted during purchase).

Following ongoing use, frequently by 4-5 yrs, medication that establish them selves safe and sound and suitable as prescription medicines may well be switched from prescription to OTC. An instance of this is diphenhydramine (Benadryl), an anti-histamine which as soon as demanded a prescription but now is readily available OTC.It is typically not viewed an OTC drug to be withdrawn from the marketplace as a outcome of basic safety issues, instead than market place forces, while it does happen occasionally. For instance, phenylpropanolamine was removed from sale in the United States about issue regarding strokes in some instances. A review has been finished analyzing consumer’s perceptions about the chance of and entry to nonprescription medicine,which concluded that a modest share of people desire owning accessibility to treatment about potential challenges of getting non-prescribed medication.Ranitidine was suspended in multiple markets due to issues over the existence of the carcinogen N-Nitrosodimethylamine (NDMA).But the make a difference obtained diluted later.

In India, the medications are detailed less than distinct schedules in the Medicine and Cosmetics Act and Medications and Cosmetics Rule. Medicine mentioned in Schedules H, H1, and X really should have a label stating that these drugs are to be sold  only on prescription of a medical professional. The medication outlined in Plan G (typically antihistamines) should have a obligatory text on the label stating, “Caution: it is perilous to choose this planning except less than clinical supervision.” Amazingly, sure essential drug types these types of as diuretics and aminosalicylates (sulfasalazine, mesalamine) are not incorporated below any drug program developing a confusion for pharmacists about offering these medicines as OTC or prescription medications.

It needs to be pressured that in India, the phrase “OTC” has no legal recognition nevertheless. It is used for the way medications are bought (self-treatment without the need of prescription or permitted to be offered by pharmacists without the prescription) rather than being a regarded formal classification of medicines in contrast to other international locations.

Timetable K of the Drug and Cosmetics Act and its Guidelines explain family cures these as paracetamol, liquid paraffin, eucalyptus oil, tincture iodine, and different formulations for the remedy of cough and chilly are the probable OTC medications. Presently, nondrug-accredited stores (e.g., nonpharmacists) can promote a few medications categorized as “Household Remedies” in Program K of the D and C Regulations in villages whose inhabitants is beneath 1000 subject matter to certain other circumstances.

Underneath the provision of the Medicine and Magic Treatments (Objectionable Commercials) Act, 1954 and Rules, 1955, the advertising and marketing and misleading promotion of some medicine/classes is retained under regulate to stay clear of self-medicine by men and women.Topical or external use of selected plan G and H class medication (except ophthalmic and ear/nose preparations that contains antibiotics and/or steroids) is exempt from the timetable. For example, topical diclofenac is not a plan H drug however diclofenac is bundled in plan H.So,factors are not pretty very clear and confusion exists.

The State Authorities of Delhi announced in 2015, that aspirin which was earlier integrated in the list of domestic solutions (Timetable K) should be offered only with a prescription in Delhi. This was for the reason that of the reality that there were being elevated variety of fatalities in dengue clients who acquired aspirin OTC.

Over-all, 52% Indians had been approximated to self-medicate in India according to a internet portal-centered study of 20000 persons throughout 10 cities. The good reasons presented have been absence of time, have to have to keep away from doctors’ fees, and dependence of web.One Indian study reported that additional than 90% of the capable pharmacists interviewed in their study were being knowledgeable about the thought of OTC medications, 96.5% questioned the people their issues when they ended up approached for buy of OTC medicine, but only 51% counselled the people concerning directions for use.

The Indian pharma sector produced whole revenues of 1.8 billion in 2009 from the medicines presumed to be OTC with an annual development rate of 10.7%. Organisation for Pharmaceutical Producers of India (OPPI) has proposed that insurance policies really should be developed for drug classification, labeling, licensing, distribution, and pricing of OTCs.

Widespread problems about OTC prescription drugs: Inappropriate use and adverse consequences

The problems about misuse, adverse outcomes like dependence (specially to sedatives, painkillers, antacids, laxatives), drug resistance, and delayed analysis of fundamental problems because of to use of OTC medications pose formidable worries.

As for every the Nationwide study information submitted by Compound Abuse and Psychological Wellness Providers administration (SAMHSA) in US, about 3.1 million people today aged 12 many years and older have misused OTC prescription drugs at the very least as soon as in their lifetime (3.7% in < 18 years old).A meta-analysis by Frei et al., threw light on the fact that over half a million Australians use analgesics over the counter for non medical purpose and OTC medicines are the third most common form of substance abuse in Australia. Similarly, in Canada, it was found that OTC medicines were widely abused.In India, abuse of OTC medicines is not well documented. One report mentions that cough syrups and antihistamine medications sold over the counter are a prevalent form of drug abuse in India.

Despite their importance, instructions for use printed on the labels of OTC medicines are often inadequate, filled in small space and are in such a format, often missed by patients. Astudy from India assessed whether labels of 100 nonprescription medicines complied with the requirements mentioned in the US FDA guidelines. It was found that 87% of the labels lacked information regarding contraindications. In 90% of the labels, adverse effects and in 96% information about their use during pregnancy and breastfeeding were missing. Overall, the label instructions were inadequate and had the potential of harming the patient’s health.Even though antimicrobials belong to the category of prescription drugs in India, they are dispensed without a prescription raising the concern regarding antimicrobial resistance as dosing and duration of such medicine courses are not properly guided or maintained.The ready availability of OTC drugs places the weakest individuals of our country at greatest risk—these are the patients from low socioeconomic strata, the elderly and others taking multiple medications, and some illiterate individuals who are not capable of evaluating safety information mentioned on the drug label. 

Optimising use of OTC medicines

Actions should be initiated under the following heads:

Prescription monitoring programs 

Prescription monitoring programs (PMPs) are useful which collect, monitor, and analyse electronically transmitted prescribing and dispensing data submitted by pharmacies and dispensing practitioners. But this will need a good infrastructure supported by govt. agency.

Spreading awareness through news and electronic media is an effective method to optimize the use of OTC medicines.

Adequate labeling 

Due to the diversity in languages spoken throughout India, apart from English, it will be appropriate to have labels in local languages for OTC drugs. Label instructions should be simple and understandable by common and less educated people. Doses specification, especially for children, is most important. It is also important to clearly mention the indications, warnings, and directions for use since the drugs are administered without medical guidance.

Distribution and delivery of OTC drugs 

India is still struggling to provide essential health care to remote places. New ways to deliver the OTC drugs to the rural population have to be conceived. India has almost 1,50,000 post offices and 9,00,000 pharmacy shops. If the services of post offices are used, the reach will dramatically increase.Conversely if the drugs are provided in places other than the pharmacy shop, then conditions necessary for proper storage need to be strictly followed.

Establishment of a subcommittee to categorize OTC drugs 

The Drugs Consultative Committee (DCC) on 18th September 2017 recommended the creation of a separate category for OTC drugs which can be legally sold over the counter. This was an important step to have a proper system to clarify all the doubts.


We need to recognise OTC medicines as a separate category of drugs in India.Earlier is better.But, at the same time,we have to understand that OTC medicine can act as a double-edged sword and due consideration has to be given to safety, abuse, and patient education in this regard. Appropriate regulation for classification, distribution, and sale of OTC medicines is the need of the hour. Strategies should be developed by the Govt. Authorities  to enhance awareness of all concerned.The pharmacists can be asked to take a strong role in this movement. Manufacturers can use pictorial description to allow safe use of such products especially by the less educated population. Surveillance for reporting of adverse effects of OTC drugs needs to be strengthened. All stakeholders must join hands to rationalise use of OTC medicines in India.

(while writing this article help
taken from study materials
available online and expert’s
opinions published in PubMed/
















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