Difference Between Prescription and Over the Counter Drugs

prescription and over the counter medicines

The medicine/drug is a substance intended for use in the diagnosis, treatment, cure or prevention of disease!

Scheduled/prescription and over the counter (OTC) medicines have their individual importance in improving the health and wellness of patients across the globe.

Understanding the difference between prescription and over the counter drugs  can help to create awareness among the patients regarding the use, safety, side effects as well as the possible interaction of medicaments.

Let’s start with the basics, what exactly prescription and over the counter medications are?

As per USFDA, prescription medication is the one that requires a written prescription from a registered medical practitioner (doctor) whereas OTC medication is the self medication and can be purchased without any prescription from drug stores.

The Drug and Cosmetic Act (1940) and Rules (1945) describe the provisions for classification of drugs under schedule and the guidelines for their sale, storage, labelling and prescription.

As per the FDA, drugs are classified into two categories: Schedule/prescription drugs (Rx only) and Over-the-counter (OTC) drugs.

Let’s focus on when a drug product requires a prescription and when it can be marketed as over-the-counter (OTC) product!

What is the Prescription drug (RX only)?

Prescription drugs or medicines are only available with a valid prescription by the registered medical practitioner. These drugs are intended to be used by the individual patient to treat a specific condition.

Prescription drugs have to pass through various clinical trial phases (human and animal study) as well as their safety and side effects are monitored even after the drug is available in the market (i.e. post-marketing surveillance).

A licensed pharmacist can only dispense prescription medicines through the pharmacy (either community/retail pharmacy or online pharmacy).

Usually prescription drugs are more potent than OTC drugs and are used for the management and treatment of both acute and chronic disease conditions.

Prescription medications are the scheduled drug:

Schedule H drug

It contains a list of medicaments that can be sold only by the prescription of a registered medical practitioner.

  • Only the specified amount mentioned on the prescription should be sold, and the date and time of dispensing must be noted.

  • The schedule H drug label must contain the symbol “Rx” and schedule H drug warning: “To be sold only by the prescription of a registered medical practitioner (doctor)”.

As per the notification, released by the Ministry of Health and Family Welfare 536 schedule H drugs are available widely.

Schedule H1 drug

It includes 3rd and 4th generation antibiotics, certain habit-forming drugs (psychotropic medication) and anti-tubercular drugs. To dispense these drugs given below criteria should be followed:

  • A separate register should be maintained containing the name and address of the prescriber (doctor), name of the patient along with the name of the drug, time of supply and the supplied quantity.

  • The schedule H1 drug level must contain the symbol “Rx in red” and schedule H1 drug warning: “Not to be sold without the prescription of a registered medical practitioner”.

Schedule X drug

It is a class of prescription drug and contains Narcotic and psychotropic substances.

  • The schedule X drug label must contain the symbol “NRx” and Schedule H drug warning: “To be sold only by the prescription of a registered medical practitioner (doctor)”.

  • These drugs are kept under lock and key, and it is mandatory that the retailer must keep a copy of the prescription for two years.

What is an over-the-counter (OTC) medication?

Over-the-counter drugs are the non-prescription medications (do not require any prescription from a registered medical practitioner).

OTC drugs are considered as safe and effective drugs for use and generally has a wider margin of safety (means a wide range of population can safely use OTC drugs) than prescription medicines. However, OTC medicines can cause severe side effects, if misused or excessive dose taken.

More than one individuals can take OTC medications. However, due to the risk of contamination, some of the OTC drugs (such as eye ointments and eye drops) are not recommended for sharing.

OTC drugs are approved and regulated by USFDA through OTC drug monographs. OTC drug monographs are a type of “recipe book” containing acceptable ingredients, formulations, doses and their labelling procedure.

As per the Consumer Healthcare Products Association, in the U.S. approximately 81% of adults use OTC medications as first-line treatment for acute/minor illness.

It is widely available for purchase on stores shelves in the pharmacy, or in stores such as supermarkets, you can also purchase it online from online pharmacy 24.

OTC products are less expensive than prescription medications.


Some prescription medicines are also available in the form of OTC products in lesser strength (lower dose). Such as Hydrocortisone ointments (prescription-strength – 2.5%) is available as a prescription only drug but a lesser strength (lower dose – 0.5%) can be purchased as an OTC product.

Restricted OTC products (behind the counter):

Restricted OTC products are legally classified as OTC medicines, but they are available only in the pharmacy as “behind the counter medications”.

For example

Cold and allergy medications having ephedrine and pseudoephedrine as an active ingredient are kept behind the counter.

The main objective of Restricted OTC products is to prevent illegal drug production. As the ingredients (ephedrine and pseudoephedrine) are used to make methamphetamine (it is a powerful brain stimulant).

Concluding, OTC medicines are the non-prescription medicines and considered as a safe and effective drug for use by the wide range of a population. Whereas, prescription medicines requires a written prescription from a registered medical practitioner and are intended to be used by the individual patient.

One should get high quality prescription and over the counter drugs at very nominal price by asking the retail pharmacist for Dr Best products. Dr Best Pharmaceuticals Pvt Ltd has taken this initiative for the first time in the country of providing both prescription as well as OTC medications at an affordable price with up to 80 % discounts.

Dr Best Pharmaceuticals are continuously working to provide medicines in various therapeutic segments like Anti-diabetic, Gastrointestinal agents, Cardiovascular agents, Lipid profile management, Analgesics, Antibiotics, OTC products and Vitamins at very nominal prices so that the treatment should not suffer..

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