Abhilashi College of Pharmacy, Ner Chowk, Mandi, H.P. 175008.
This study examines the vital role that over-the-counter (OTC) medications play in contemporary healthcare, highlighting their affordability, accessibility, and role in self-medication. It explores the regulatory frameworks, approval procedures, and categorization criteria put in place by organizations like the FDA and WHO to guarantee consumer safety. The study emphasizes the advantages of over-the-counter medications as well as their possible drawbacks, such as drug abuse, incorrect self-diagnosis, and unfavorable drug combinations. The characteristics of the Indian OTC industry, the growing tendency of OTC drug addiction among youth, and the impact of online promotion and advertising tactics are given particular attention. The Rx-to-OTC move and its effects on pharmaceutical businesses and public health are also examined. The study emphasizes the significance of consumer education, regulatory vigilance, and appropriate usage behaviors to protect public health by evaluating current opportunities and difficulties. All things considered, the study provides a thorough understanding of the changing OTC medicine market and its significant influence on healthcare systems around the globe.
Over-the-counter products are often available to consumers without a prescription from a doctor. Most over-the-counter drugs are approved by the government and contain safe, efficient ingredients that don't require a prescription [1]. Frequent headaches, allergies, the common cold, constipation, backaches, acidity, and chronic fatigue are among the typical ailments that can be treated on a daily basis without a doctor's supervision. Up to 90% of people in developing countries are said to self-medicate. Inappropriate self-medication increases health care costs. Studies have shown that a range of cultural, political, and environmental factors influence the use of self-medication to prevent or treat symptoms and diseases [2]. When access to pharmaceuticals is increased without corresponding increases in health literacy, the risk of prescription addiction increases. Some of the most popular drugs require a prescription in order to be delivered, in contrast to over-the-counter drugs. Some countries have seen a rise in the use of over-the-counter drugs, which could lead to abuse. Almost any chemical has the potential to be misused if we define misuse as the willful use of a substance to the point of causing physical or psychological harm. This notion is especially plausible if the substance alters a person's perception of his environment. About 400 conditions can be treated or cured with nonprescription drugs, which make up around 60% of all pharmaceuticals used in the US. Between 1975 and 1994, thirty percent of newly marketed over-the-counter (OTC) medications were goods that were formerly prescribed but were now available over-the-counter [3]. Today's teen population is capable of purposefully abusing over-the-counter (OTC) and prescription (Rx) drugs to get high. In India, medications that are not classified as prescription drugs are typically referred to as over-the- counter medications.
Over-the-counter drugs:
Over-the-counter (OTC) medications are medical supplies that, in accordance with national laws, may be offered to customers directly without a prescription. OTC drugs are mostly used as a first-line or initial treatment for a variety of mild, self-limiting illnesses, such as the common cold, allergies, heartburn, musculoskeletal pain, and headaches. The primary criteria used to choose medications in the over-the-counter category are their efficacy and safety. The World Health Organization (WHO) states that self-medication is a crucial component of the changing healthcare system, with a primary focus on raising consumer awareness, educating consumers, as well as socioeconomic standing [4].
According to different organizations and associations
Pharmacologists often describe OTC drugs as products that are regulated by health authorities and can be used without the supervision of a healthcare professional. These drugs have been reviewed for their safety, efficacy, and proper usage to ensure that they can be safely used without medical intervention for common health issues, such as pain relief or cold symptoms.
5. National Institutes of Health (NIH):
• The NIH states that OTC drugs are those medications that can be bought over the counter at pharmacies or stores, without a doctor’s prescription, for the treatment of common ailments. These drugs are regulated for safety and effectiveness through the FDA [6].
6. European Medicines Agency (EMA):
• The EMA refers to OTC drugs as medicinal products available for public purchase that are considered safe for use without a prescription. They are generally used for self- medication, as they are for minor conditions where professional oversight is unnecessary.
Prescription and over-the-counter medication lifecycles:
Depending on its inherent toxicity, intended use, dosage form, posology, and safety, the medications are divided into prescription and non-prescription drug categories. Reclassifying a medicine in a downward or upward status is significantly influenced by the safety information gleaned from market experiences. In contrast to the non-prescription drug category (OTC), medications for catastrophic disorders are primarily classified as prescription drugs and are therefore continuously controlled throughout their existence. A direct-to-OTC drug product may be submitted as a new drug application (NDA). Nonetheless, a large number of FDA-approved OTC medicine products (that is, OTC goods with an approved NDA) start out as prescription drugs with an NDA and then transition to OTC status in accordance with the NDA's requirements. This procedure is often called a Rx-to OTC changeover. However, substituting a prescription medication or new chemical entity that satisfies the necessary requirements of to support the switch to non-prescription selling, the following further requirements must be met: inherent toxicity, intended use, dose form, posology, and safety [7]. (Figure 1).
Figure 1: Life cycle of OTC medication
Factors Associated with Teens Abusing Over-the-Counter Drugs:
Reasons why teenagers believe over-the-counter drugs are safe since they can be easily obtained from peers, parents, siblings, and home medicine cabinets; they are available without a prescription in pharmacies, supermarket and convenience stores, and other retail establishments; and they are frequently reasonably priced[8]. Roughly 90% of teenagers report using over-the- counter (OTC) drugs exclusively for self-medication by the age of. Along with becoming more self-reliant, teenagers frequently absorb the beliefs, attitudes, and actions of their parents. As a result, parents—mothers in particular—have a significant impact on teenagers' awareness, understanding, and medication-taking habits regarding over-the-counter medications. Other potential influences include family members, friends, medical professionals, the media, commercials, drug box inserts, and websites that encourage the misuse of over-the-counter pharmaceuticals. According to reports, children who learned about the dangers of over-the- counter drug use from their parents were less inclined to take it. Teenagers' knowledge and opinions about the safe use of pharmaceuticals are shaped by their experiences in their families, communities, and surroundings; if they have inaccurate information regarding over-the-counter medications, this could be detrimental[9]. Another factor that leads to misuse is adolescents' inadequate understanding of over-the-counter drugs. They are aware that OTC drugs are readily available to them, but there is a dearth of knowledge about the purpose, application, and effects of medications. According to one study, adolescents' average score on an OTC medicine knowledge survey was roughly 44%. The results also imply that adults who would provide care for this susceptible group may also have little understanding. Teenagers have expressed little knowledge of dosage, adverse effects, mixing over-the-counter drugs, and long-term safety hazards. Despite identifying both as typical sources of health information, only 8% of teens stated that medications should be taken as directed by a doctor or on the box insert. A troubling discovery is that many teenagers say their medications are satisfactory even if they know very little about them regrettably; the outcome could be inadvertent abuse and an increased chance of adverse health effects. This population's prevalence of OTC abuse may also be influenced by demographic factors [10].
OTC Market in India:
In terms of the global OTC market, India is ranked eleventh, and the OTC medicine industry is expanding at a rate of twenty-three percent, according to statistics gathered in 2012[9]. Approximately 70,000 trademarks are utilized as OTC medications. Revival, Crocin, Smyle, Glycodin, and other brands are the most commonly used. By 2020, the Indian pharmaceutical sector is poised to emerge as a significant worldwide market. Cough syrups, Vicks VapoRub, Zandu balm, Iodex, Moov, cough drops, and Dabur Honitus lozenges are a few of the leading over-the-counter (OTC) brands in India. One of India's most significant economic sectors is the pharmaceutical sector, which exports goods worth $15 billion annually every year, and some of its factories are of the highest caliber. Prescription and over-the-counter medications are the second-largest exports from India to the US. The over-the-counter drug market in India is projected to grow at a compound annual growth rate (CAGR) of 5.39% from 2025 to 2030, from an estimated USD 7.09 billion in 2025 to USD 9.22 billion by 2030. Product innovation, consumer shifts toward self medication, and pharmaceutical companies' preference for over-the- counter (OTC) pharmaceuticals over prescription ones in the nation are the main drivers of the OTC drug sector's growth. Furthermore, a March 2024 research in the Sage Open Medical Journal states that the increasing rate of self-medication, especially in metropolitan areas, is fueling the expansion of the over-the-counter (OTC) business in India, with time constraints and convenience serving as the main drivers. Consumer demand for readily available healthcare solutions is demonstrated by the widespread usage of allopathic medications and dependence on pharmacist suggestions. Demographic variables including increased rates of self-medication among women and skilled workers further support this trend, suggesting that the OTC drugs sector has a considerable potential. Because so many Indians self-medicate, the market for over- the-counter medications is anticipated to expand quickly over the course of the forecast period [11]. (Figure 2)
Figure 2: Life Cycle of OTC Medication
The Analgesics Segment is Expected to Witness Significant Growth During the Forecast Period:
Over the course of the forecast period, the analgesics segment is anticipated to have significant growth. Increases in the number of people suffering from headaches, fever, toothaches, musculoskeletal injuries, disorders, menstrual cramps, and product releases by major market participants are the main drivers of the growth of over-the-counter (OTC) medications in the analgesics area. Since analgesics are easily accessible and do not require a prescription, pain- related problems are major factors in the self-medication of these medications [12]. Over the course of the projected period, the Indian population's increasing tendency to self-medicate with over-the-counter analgesics is anticipated to boost market growth. For example, the high rate of self-medication (SM) with non-opioid analgesics (NOA) is fueling the expansion of the over-the-
counter (OTC) analgesic market in India, per a June 2023 article published in the Patient Preference and Adherence Journal. This pattern highlights the growing need for readily available and regarded as safe pain relief medications, like paracetamol, which is frequently taken in spite of possible hazards, hence increasing market prospects for producers of over-the-counter analgesics. The market is expected to develop as a result of the introduction of new products and the growing trend of self-medication using over-the-counter analgesics. Likewise, in order to avoid the time and expense of seeing a doctor or hospital, patients choose self-medication for ailments like fever and headaches. For rapid symptom alleviation, consumers rely on over-the- counter medications for fevers and headaches. The sale of over-the-counter medications for analgesics is rising in India as a result of their ease of procurement and rising market demand [13]. For example, OTC medications in the analgesic family saw a 23% increase in sales compared to 2022, according to data released by the Indian government in November 2023.
Cough, Cold, and Flu Products Segment is Expected to Hold a Significant Share in the Market During the Forecast Period:
Due to the rise in flu cases in recent decades, which has led to a significant medical and financial burden, the prevalence of cough, cold, and flu diseases in India has increased dramatically, creating a significant opportunity in the country's over-the-counter market[11].Rising flu cases, increased demand for over-the-counter cough and flu remedies, and a growing trend toward self- medication are some of the factors driving the expansion of over-the-counter flu treatments in the nation's market. Similar to this, the Union Health Ministry, the nation's central drug regulatory body, is preparing to introduce a new program in May 2024 that would allow over-the-counter medications to be sold in general stores [14].. The goal of the action is to lower the cost and increase the accessibility to common pharmaceuticals, particularly for low-income individuals and households in rural areas. at addition to improving accessibility and cost for the populace, the government is working to boost the availability of medications by extending the reach of over-the-counter medications and allowing them to be purchased at general stores. The Indian market for gastrointestinal products is expanding as a result of this easier access. In order to meet the growing demand for over-the-counter flu medications in the nation, major market participants are also developing innovative growth methods. Dolo 500, Dolo Pain Relief Gel, Dolo Spray, Dolosils cough lozenges, and other over-the-counter items including skin ointments, nicotine gum, and ORS are just a few examples of the brand extensions Micro Labs plans to add to its medicinal offering market in May 2024. Throughout the projection period, it is anticipated that such actions by major companies will fuel market expansion. In conclusion, the government's efforts to improve pharmaceutical accessibility and the notable increase in flu prevalence are fueling the Indian over-the-counter drug market's rapid growth, which is being supported by calculated expansions by key industry participants [15]. (Figure 3)
Table:1 The Following Are Some of The Primary Groups of OTC Market Participants:
|
Market Overview |
The Indian OTC drug market is highly competitive, featuring domestic and international firms. It remains fragmented, with no single entity holding a dominant market share. |
|
Key Domestic Players |
Emami Limited, Dabur India Limited, Sun Pharmaceuticals Limited, Cipla Inc. |
|
Key International Players |
Procter & Gamble, Abbott Laboratories, GlaxoSmithKline PLC, Johnson & Johnson. |
|
Market Trends |
1. Growing preference for preventative healthcare products. 2. Rising shift toward self-medication. |
|
Future Strategies |
- Product diversification. - Digital transformation. - Rural market penetration. - Strategic alliances. |
|
Competitive Advantages |
Procter & Gamble & GlaxoSmithKline PLC – Strong brand recognition and global reach. Emami Limited & Dabur India Limited – Expertise in regional preferences and herbal/Ayurvedic products. Abbott Laboratories & Johnson & Johnson – Broad product portfolios, including branded and generic OTC drugs. |
Figure 3: The Following Are Some of The Primary Groups of OTC Market Participants:
Challenges occur in switching Rx to OTC: `
Although there are encouraging growth indicators for the Rx-to-OTC process in the Indian Pharmaceutical business, there are now major transitional obstacles to overcome [16].
Currently, Rx-to-OTC changeover may bring the following difficulties:
Inaccurate Self Diagnosis:
Despite the fact that the illness has changed, patients might still take over-the-counter medications based on their prior experiences. When a patient receives an inaccurate diagnosis, they use many over-the-counter (OTC) medications that might not be useful in curing real illnesses. For instance, if a healthcare provider has previously diagnosed a vaginal fungal infection, women are more likely to diagnose the ailment and utilize over-the-counter antifungal medications. As a result, many women in this situation who have never received a fungal vaginitis diagnosis take antifungal medications. As a result, it results in negative medication effects and other health issues [17].
Opportunities
The causes include rising consumer knowledge, the rise in self-medication, and government initiatives to reduce public spending on prescription drugs for minor conditions that may be treated on one's own [13]. Reasons for converting prescription medications to over-the-counter status. The public healthcare system saves a significant amount of money each year because to the availability of Rx-to-OTC drugs [18]. The Rx-to-OTC changeover procedure improves the consumer's perception of safe and efficient medications. As a result, there is an increasing demand for over-the-counter medications. In the modern world, people's lives are getting more stressful and complicated. Pharmaceutical firms are a result of the daily rise in both acute and chronic disorders. In order to satisfy people's needs, the pharmaceutical corporation produces additional pharmaceutical items. Growing availability of over-the-counter medications gives customers new chances for self-care. Pharmaceutical companies have the opportunity to extend the life cycle of their drug products through the Rx-to-OTC changeover procedure. When a prescription drug's patent expires, switching also helps the business defend against generic competitors entering the market. Drug patents can be prolonged by changing its status to OTC. These could include medications for children, formulations with extended release, etc. The Rx- to-OTC process, then, is a means of managing the drug's life cycle and of fostering the expansion of the pharmaceutical business. Pharmaceutical businesses will see high rates of rapid sales growth and increased manufacturing as a result of a new medicine switch. This aids in the company's market strategy expansion [19]. The pharmaceutical industry, which can offer people enough jobs, is one of the industries least impacted by the recession. The pharmaceutical business in India is expanding at a rate of about 16% per year, according to the OPPI 46th annual report. Based on the information approximately 4 million people were directly employed by the Indian pharmaceutical sector as of 2013. Thus, switching aids in resolving the global unemployment issue. Approximately 96% of customers think that over-the-counter medications can be used to treat mild illnesses [20]. For first-line defence in healthcare activities, the majority of customers rely on over-the-counter drugs. For instance, OTC cough medications are the first line of treatment for consumers who want to alleviate their own and their children's cough symptoms. The transition from one allergy to another OTC medications are now accessible and reasonably priced. Because of this, the percentage of persons utilizing over-the-counter medications rose from 66% in 2009 to 75% in 2015. As more medications are developed, the category of over-the-counter drugs has expanded. The transition from prescription-only to over- the-counter medications is made possible by the availability of information about the safety, efficacy, and use of the medications. Signs such as cholesterol based on consumer knowledge and understanding, conditions like menorrhagia, incontinence, obesity, and other conditions that were previously thought to be managed solely under medical supervision can now be moved to over-the-counter medications. Some medications have the ability to leave the prescription drug industry. These consist of naloxone, albuterol, epi-pen, oral contraceptives, and triptan for migraines [21].
Types of OTC drugs:
For many people, over-the-counter (OTC) medications are the preferred option for treating mild illnesses. These medications are readily available, reasonably priced, and non-prescription. Over- the-counter medications are used to treat a variety of ailments, including allergies, the common cold, headaches, and fevers[22]. OTC medications fall into a number of categories, each intended to address particular ailments and symptoms. Among the most popular categories of over-the- counter medications are: (Figure 4)
Figure 4: Different types of OTC Drugs
Sleep Aids: These medications help people fall asleep and deal with insomnia. There are various sorts of sleep aids, such as drinks, tablets, and capsules. Diphenhydramine, valerian root, and melatonin are a few examples of sleep aids. OTC medications can have adverse effects and interact with other medications, even though they are usually safe and effective. If you have any questions or concerns, it is always advised to thoroughly read the label and speak with a healthcare provider [24].
Risks And Side Effect of OTC Drugs:
It's critical to understand the possible risks and adverse effects of any drug before using it. OTC medications are readily available and frequently used to treat mild ailments and symptoms. However, this does not imply that they are entirely safe for everyone, even though they are accessible without a prescription. In actuality, if taken improperly, over-the-counter medications can have a number of negative effects that might be dangerous or even fatal. To make sure you are making the best choices for your health, it is critical to comprehend the risks associated with using over-the-counter medications [25]. (Figure4)
Figure 4: Different types of OTC Drugs
1. Overdose concerns: The possibility of overdosing is one of the main concerns connected to over-the-counter medications. The active components in many over-the-counter medications have the potential to be hazardous at excessive dosages. If you are taking several drugs at once, this is particularly true. For instance, excessive consumption of acetaminophen, which is present in Tylenol and other painkillers, can harm or even kill the liver. Similarly, excessive use of ibuprofen, which is present in Advil and other nonsteroidal anti-inflammatory medications, can result in kidney damage, bleeding, and stomach ulcers [26].
2. Allergic Reactions: The possibility of allergic reactions is an additional risk connected to over-the-counter medications. Certain active chemicals in over-the-counter medications may cause allergies in certain people, which can manifest as symptoms like hives, swelling, or trouble breathing. An allergic reaction might be fatal in extreme circumstances. If you have any worries regarding allergies, it's crucial to thoroughly read the labels of over-the-counter medications and consult a healthcare provider.
3. Interactions with Other Medications: Over-the-counter medications may also have interactions with other prescription drugs you are already taking. If you are using prescription prescriptions, this can be particularly risky because over-the-counter drugs can change the way these treatments work or possibly reduce their effectiveness. Dextromethorphan, which is present in Robitussin and other brands of cough and cold remedies, for instance, can combine with some antidepressants and result in serotonin syndrome, a potentially fatal illness [27].
4. Additional negative Effects: Depending on the substance, over-the-counter medications may have additional negative effects in addition to the dangers mentioned above. For instance, certain painkillers may result in indigestion or upset stomach, while others may make you drowsy or lightheaded. If you have any concerns about possible side effects, it's crucial to thoroughly read the labels of over-the-counter medications and consult a healthcare provider. Even though over-the-counter medications can be useful in treating mild conditions and symptoms, it's crucial to be aware of the possible risks and adverse effects involved. Always pay close attention to the directions and dosages on the labels. Before taking any drug, see a healthcare provider if you have any questions or concerns.
Benefits of OTC drugs:
OTC drugs have become a go-to solution for people who are looking for quick relief from common ailments such as headaches, colds, and allergies. The benefits of OTC drugs are numerous, and these drugs have become increasingly popular in recent years due to their convenience and accessibility. It's important to note that while OTC drugs are generally safe, they can have side effects and should be used only as directed. In this section, we will explore the benefits of OTC drugs from different perspectives to help you better understand their advantages [28].
Figure 6: Benefits of OTC Drugs
Safe and Effective use of OTC:
OTC medications are a practical and economical means of treating a number of common medical issues. To prevent any negative effects and issues, it is crucial to utilize them in a safe and efficient manner. OTC medications can be a great way to treat minor illnesses and enhance general health if used with the appropriate information and safety measures [30].
1. Pay attention to the labels: It's crucial to carefully read the labels and adhere to the directions before taking any over-the-counter medications. This will guarantee that you are taking the medication safely and properly and help you prevent any negative effects.
2. Check with a healthcare expert: It is always a good idea to speak with a healthcare professional if you are unclear about which over-the-counter medication to take or if you have any questions about how to use them safely and effectively. They can offer you insightful counsel and direction to assist you in making the healthiest choices possible.
3. Utilize over-the-counter medications as directed: Abuse or abuse of over-the-counter medications can result in major health issues. It's crucial to take them exactly as prescribed and to refrain from exceeding the suggested dosage.
4. The types of OTC pharmaceuticals that are safe and effective: include painkillers such as acetaminophen and ibuprofen, allergy antihistamines, and cough and cold remedies. When taken as prescribed, these medications are usually safe and effective in treating a wide range of common illnesses [31].
Advertisement Of OTC Drugs:
A list of illnesses for which advertising is prohibited is mentioned in the Drug & Magic Remedies (Objectionable Advertisement) Act. Additionally, it forbids deceptive advertising that, either directly or indirectly, creates false perceptions about the actual nature of the medication, makes false claims, or is otherwise deceptive or false in any way. All OPPI member companies are adhering to the Voluntary Code on OTC Advertising, which was released by the DCGI's office in cooperation with OPPI. Although it is industry practice not to advertise prescription- only medications, there is currently no particular regulation that forbids this activity. A statement banning the promotion of any medication that legally requires a prescription from a doctor to be purchased is being considered by the DCGI's office [32].
In India, The Following Over-The-Counter Medications Are Advertised on Television:
• Digestives
• Antacids
• Cold rubs, analgesic balms and lotions, and vitamins, tonics, and health supplements (particularly herbal and Ayurvedic-registered ones) Cold or analgesic tablets;
• Antiseptic liquids or lotions
• Medicated skin care
• Powdered glucose
• Medicated dressings (band-aids); cough drinks; lozenges for the throat; and baby gripe water.
• Non-steroidal anti-inflammatory drugs, vasodilators, and anti-acne medications for Quitting Smoking [33].
TV, print, radio, the internet, and social media are just a few of the media platforms that can be used to promote over-the-counter products. Advertisements can target particular customer segments and demographics while showcasing the product's qualities, advantages, and applications.
Advertising: One of the main strategies used to promote over-the-counter products is advertising. In order to reach a large audience, this entails developing and distributing convincing messages over a variety of media platforms. Traditional media, such as radio, print (magazines, newspapers), and television, can be used to promote over-the-counter products. Additionally, online platforms including websites, banners, and social media are part of contemporary advertising strategies.
TV Advertising: The visual and aural elements of television commercials for over-the-counter products make them powerful. These advertisements can include pertinent information, show the product in action, and emphasize its advantages. TV advertisements are appropriate for products with a wide range of appeal since they may reach a sizable and varied audience.
Print Advertising: Print media comprises ads in newspapers, magazines, flyers, and brochures. The qualities, advantages, and use of the product are covered in greater detail in these commercials. Reaching particular readers of the magazine is possible with print media.
Radio Advertising: Since radio advertisements use sound to communicate information, they are appropriate for advertising over-the-counter (OTC) goods that are simple to explain without the use of visual aids. To make an impression, radio commercials frequently use memorable slogans, catchy jingles, and unambiguous messaging [34].
Online Advertising: To reach customers, online advertising makes use of the internet. This covers search engine advertising, video adverts on websites like YouTube, and display ads on websites. Businesses can reach particular user profiles and demographics with highly targeted online advertising. Product Highlighting: Over-the-counter product ads emphasize the special qualities and advantages of the product. This can involve demonstrating how the product solves a particular issue or demand of the customer, increasing its attractiveness to prospective purchasers.
Targeted Advertising: To target particular demographics and consumer categories, advertisers frequently employ data analytics and consumer insights. This increases the likelihood of creating interest and purchases by ensuring that the promotional messages are received by the appropriate target [35].
Consumer Education: By clearly outlining how to utilize the product in a safe and efficient manner, several over-the-counter product commercials place a strong emphasis on consumer education. Customers are encouraged to make knowledgeable purchasing selections and their trust is increased as a result.
Important Elements of Over-the-Counter Personal Selling:
In-Person Interaction: Salespeople interact with managers, pharmacists, and shop employees in person when they visit retail locations. Direct communication and prompt resolution of any questions are made possible by this method [36].
Product Knowledge: Sales personnel are well-versed in the OTC product's components, benefits, usage guidelines, and possible drawbacks. They are able to give retailers precise and pertinent information because of their knowledge.
Developing Relationships: Sales reps and retailers develop relationships through personal selling. Better product placement on store shelves and greater visibility might result from building credibility and trust [37].
Product Demonstration: To illustrate prospective customers the value of a product, salespeople might provide live demonstrations of its operation and efficacy.
Training: In addition to product promotion, personal selling may entail educating pharmacists and medical experts on the advantages, possible side effects, and correct usage of over-the- counter medications. Customers' trust in the product can then be increased by sharing this information with them.
Benefits of OTC Product Personal Selling:
Personalized Communication: Salespeople can adjust their pitch to the unique requirements and worries of merchants through direct communication [38].
Instant input: Salespeople are able to get merchants' input in real time, which helps manufacturers make the necessary changes or enhancements to the product.
Effective Communication: It is possible to communicate complicated or technical information in a way that makes sure retailers fully comprehend the product. Relationship Building: Personal selling helps manufacturers and merchants establish enduring bonds that may eventually result in further collaborations [39].
Customized Training: Pharmacists and other medical professionals can obtain individualized training through personal selling, which improves their capacity to make appropriate product recommendations to customers.
Direct mail
Using statistical or purchase history information, direct mail campaigns can be tailored to specific customer categories. Coupons, product samples, and other incentives can be added to direct mail campaigns to promote product trial and purchase.
Advantages of Direct Mail for OTC Products:
Targeted Reach: Businesses can use direct mail to target particular customer segments with offers and messages. To advertise a vitamin supplement, for example, a business can send direct mail to households with people who have expressed interest in wellness and health items.
Personalization: Sending recipients tailored direct mail can make their experience more interesting and unique. The possibility of a favorable reaction might be raised by mentioning the recipient by name and attending to their particular requirements or worries [40].
Tangible Presence: Receivers can hold and interact with physical mail objects, giving them a palpable presence. Brand memory and recognition may be improved by this tactile sensation.
Coupons & Sampling: Product samples and discount coupons are frequently included in direct mail advertising. Free samples of over-the-counter products are sent to customers so they can personally feel their benefits, and coupons encourage them to buy.
Call to Action: A clear call to action, such as visiting a website, using a coupon code, or going to a nearby retail location to make a purchase, is usually included in direct mail campaigns [41].
How to Run an OTC Product Direct Mail Campaign:
Segmentation: Determine the target market by looking at things like demographics, location, and purchasing patterns.
Statement Development: Create an engaging and succinct statement that speaks to the wants or problems of the target audience while emphasizing the advantages of the over-the-counter product [42].
Design: Create aesthetically pleasing and captivating mail pieces that appeal to the target audience and are consistent with the brand's identity.
Incentives: To encourage recipients to act, provide incentives like product samples, vouchers, or exclusive deals.
Distribution: Direct mail pieces are sent to the addresses of the chosen recipients using mailing lists [43].
Follow-Up: To further engage interested recipients, track the campaign's effectiveness and send out follow-up messages or promotions.
To promote over-the-counter (OTC) products and increase website traffic and sales, online marketing and advertising strategies including search engine optimization (SEO), pay-per-click (PPC) advertising, social media marketing, and email marketing can be employed[44].
Search Engine Optimization (SEO): SEO is the process of making a website more visible in search engine results by optimizing its content, structure, and keywords. OTC product websites can rank better in search results and make it simpler for potential buyers to find the products by improving product descriptions, employing relevant keywords, and making sure the website navigation is user-friendly.
Pay per click (PPC): Ads are placed on search engines and other online platforms as part of pay-per-click (PPC) advertising. Only when people click on their adverts do advertisers get paid. PPC campaigns for over-the-counter products can target particular product-related keywords, guaranteeing that customers who are actively looking for those items see the adverts [45].
Social Media Marketing: Direct communication with customers is possible through social media platforms. To communicate product details, instructional materials, user reviews, and promotions, over-the-counter product businesses can set up accounts on social media sites like Facebook, Instagram, and Twitter. Relevant hashtags and captivating images might aid in expanding your audience.
Influencer Marketing: OTC items can be made more visible by working with influencers who have a sizable following and a robust internet presence. Through their material, influencers can evaluate, showcase, or recommend things, providing a believable viewpoint that appeals to their audience [46].
Information Marketing: Producing informative and useful information about over-the-counter drugs can draw in new clients. By educating customers on the advantages, applications, and efficacy of the products, blogs, articles, infographics, and videos can position the business as a trustworthy information source [47].
Email Marketing: Email marketing is the practice of delivering a subscriber list customized emails. To entice customers to act and buy, brands can deliver newsletters, deals, product updates, and educational materials straight to their inboxes. +
Online Discounts and Coupons: Customers may be encouraged to select over-the-counter (OTC) products over alternatives by providing them with online-only discounts, coupons, or promotional codes. The brand's website, social media accounts, and email campaigns can all be used to promote these offers [48].
User Testimonials and Reviews: Presenting authentic user reviews and testimonials on product pages helps increase credibility and trust with prospective buyers. Purchase decisions may be influenced by other customers' positive experiences [49].
Interactive Online Tools: By developing interactive tools, like product recommendation tests or symptom checkers, users can be engaged and directed to appropriate over-the-counter products. These resources are beneficial and motivate users to investigate the product line [50].
Rule and Regulations of OTC drugs:
Medications that can be bought over-the-counter (OTC) do not require a prescription. The Food and Drug Administration (FDA) is in charge of regulating over-the-counter (OTC) medications in the US. The FDA has strict guidelines to make sure that these medications are safe, effective, and appropriately labeled. The following are the primary guidelines pertaining to over-the- counter medications[51]:
The FDA regulates the efficacy and safety of all over-the-counter medications. The FDA establishes guidelines for the production, labeling, and promotion of over-the-counter drugs[19]. The monograph requirements, which are essentially a collection of rules outlining the permissible ingredients, dosages, formulations, and labeling for different types of over-the- counter drugs (such as painkillers and cold remedies), must be met by OTC medications. A new drug application (NDA), which calls for additional testing and data but permits the drug to be dispensed without a prescription, can be used to approve a medication that does not fit under a monograph[52].
The FDA has established comprehensive guidelines known as monographs for specific drug categories, such as antacids and antihistamines [53]. Over-the-counter medications that adhere to these monographs don't require further clearance beyond the typical evaluation. Application for New Drugs (NDA): Manufacturers must submit an NDA, which entails more thorough clinical research to verify safety and efficacy, before a medicine can be commercialized if it is novel or does not comply with an existing monograph [54]
3. Labeling Specifications
OTC medications are required to carry a Drug Facts label, which includes important details like: The quantities of active components The drug's purpose Applications and signs Warnings, such as side effects and contraindications Instructions for dosage Instructions for storage Details about the manufacturer Instructions for safe use and cautions regarding possible abuse or adverse effects must also be included on labels[55].
GMPs or good manufacturing practices:
Good Manufacturing Practices (GMP), which guarantee that medications are manufactured in a quality-controlled environment, must be followed while producing over-the-counter medications. This covers routine facility inspections, ingredient testing, and accurate documentation.The purpose of GMP laws is to guarantee the safety and uniformity of product quality[56].
Promotion & Promotion
OTC medication advertising must be honest and not deceptive. To make sure that claims stated in advertisements are backed up by scientific data, the Federal Trade Commission (FTC) controls advertising for over-the-counter medications. Any assertions on the efficacy of an over-the- counter medication must be supported by evidence, and the advertisement is not allowed to make inflated or inaccurate claims of the medication's advantages[57].
Safety Reporting and Monitoring
Manufacturers are required by the FDA to disclose any negative events or side effects associated with their over-the-counter medications. This enables the FDA to keep an eye on the safety of medications that are sold. The FDA's MedWatch program, which keeps an eye on the safety of medications after they are put on the market, also allows consumers and healthcare professionals to report side events[58].
Limitations on Specific Substances
Some over-the-counter medications are subject to further regulations. For example, the Combat Methamphetamine Epidemic Act restricts the sale of pseudoephedrine, a popular ingredient in cold and allergy medications, because it may be used illegally to produce methamphetamine. In some jurisdictions or nations, some drugs, such as those that contain codeine, may be sold over- the-counter; however, they are subject to regulations and require proof of identity and age[59].
Security and Efficiency
An over-the-counter medication must be scientifically validated as safe and effective for its intended purpose before it can be put on the market. If new information suggests a medicine is hazardous or ineffective, the FDA may occasionally withdraw it from the market or mandate changes to its marketing[60].
Consumer Education
The FDA advises customers to carefully read and follow the directions on over-the-counter medications. Adverse effects can result from OTC drug abuse, and certain pills may have unfavorable interactions with other prescription AAA.
Specific Drug Regulations
There may be further rules pertaining to the category or active ingredients of some over-the- counter drug kinds, such as cough syrups, painkillers, or allergy prescriptions. Ensuring that over-the-counter medications are safe for consumer use, appropriately labeled, and marketed without deceptive claims is the overall objective of the laws [61].
CONCLUSION:
The study on over-the-counter (OTC) drugs highlights their significance in self-medication, offering accessibility, affordability, and convenience for treating minor health conditions. OTC drugs, classified into various categories such as pain relievers, antihistamines, antacids, and cough syrups, play a vital role in public healthcare. However, despite their benefits, they pose risks such as misuse, overdose, and harmful drug interactions. Regulatory frameworks, established by organizations like the FDA and WHO, ensure the safety, effectiveness, and proper labeling of OTC drugs. However, challenges such as self-medication without proper knowledge, incorrect dosages, and dependency on certain drugs remain prevalent. The study also reveals that many consumers lack sufficient awareness regarding the responsible use of OTC drugs, emphasizing the need for education on reading labels, understanding contraindications, and consulting healthcare professionals when necessary. To mitigate the risks associated with OTC drug misuse, stronger regulatory enforcement and public awareness campaigns are essential. Pharmacists and healthcare providers should actively educate consumers on proper medication practices. Future research should explore the long-term effects of OTC drug use and evaluate the impact of awareness programs. In conclusion, while OTC drugs are beneficial in promoting self- care, their safe and responsible use must be prioritized to prevent adverse health consequences.
REFERENCES
Dr. Shivalika *, Rohit Dhiman, Sachin, The Silent Pillars of Self-Care: A Deep Dive into Over-the-Counter Drug, Int. J. of Pharm. Sci., 2025, Vol 3, Issue 5, 3066-3088. https://doi.org/10.5281/zenodo.15458796
10.5281/zenodo.15458796
