Dangers of Easy Availability of Prescription Medicines

 In 2017, the General Secretary of the Indian Pharmaceutical Association (IPA) issued a letter addressing the alarming practice of making prescription medications being easily accessible to patients. The Prime Minister of India even outlined its concern in one of his “Mann Ki Baat” talks. The letter issued by IPA outlined a step-by-step approach to combat this issue. Adverse drug reactions are a significant problem in India due to such matters, contributing to both mortality and morbidity, mainly due to poor enforcement of drug regulations. Self-medication remains a considerable challenge, and India’s reputation as a hub for “prescription drug tourism” stems from the widespread availability of medications. Promoting the responsible use of medicines is a crucial focus of the IPA’s campaigns, but there is a need for something more to curb the chronic problem.

Prescription and Non- Prescription Drugs: What are they?

Commonly called “prescription medicines,” they have been categorised into various Schedules (Schedule H, Schedule X, Schedule H1), depending on certain factors, such as potential side effects, habit-forming or misuse potential, and new drugs. The labels of such medicines warn patients of the effects-

“Not to be sold by retail without the prescription of a Registered Medical Practitioner”.

However, reading it on the label is often challenging and needs to be addressed. While certain medicines, by law, can be sold without a prescription. They are commonly called “non‐prescription” or “OTC” medicines.

Extent of the problem

There are no statistics/records to show that it is a common practice that most of the time, “prescription medicines” are available/sold in many/most pharmacies without a valid prescription, as highlighted by IPA. The extent of the problem could vary from pharmacy to pharmacy. After introducing the Schedule H1 category of medicines on 01‐03‐2014, many pharmacies sell them only against a valid prescription. However, the issue arises as many pharmacies may not bother much and selling almost any medicine to anyone without a valid prescription is grave. Most of the time, no prescription is given by the patient at the pharmacy. They request prescription medicines by producing old strips, bottles, and covers or showing SMS messages on mobile devices.  Allopathic prescriptions written by Quacks, doctors of non‐allopathic systems of drugs, are also presented at the pharmacy and are dispensed most of the time by most pharmacies, even though not permitted by law. Large quantities of prescription medicines purchased without a valid prescription are taken abroad. So, we cannot even claim that people aiding in practice are from ignorant lot alone.  IPA also highlighted how technology is defeating law, as prescription medicines are available online through the internet and sent to the address specified by the client. No prescription is asked for. The sale of prescription medicines often happens again in the absence of a Registered Pharmacist, a breach of the law.

Thus, different pharmacies and individuals or practitioners break the law to varying degrees under different circumstances. This has become a chronic problem across the country—so much so that it seems to have become a “part of life,” and very few complain about it or consider it important to raise the issue or even think of doing something about it. The problem in India is widespread and dangerously grave.

Pharmacies know that it is not legal to sell without a valid prescription, but it has become a part of the system to sell without a prescription. It has reached such a point that if a patient is asked for a prescription, it is considered a strange practice. A fact that the patient dislikes is that if a pharmacy decides to “strictly” follow the law and not sell single prescription medicine without a valid prescription, there is a high possibility that the pharmacy may soon have to be closed—insufficient regulatory officers to carry out routine inspections. Pharmacies are either forced to bribe, or many are happy to bribe to be allowed to carry on wrong practices. It has become an accepted part of the system.

There is a need for more awareness amongst the public that a prescription is mandatory to buy certain medicines. The public doesn’t see the necessity of a prescription each time. Because of this, patients/clients insist that they be dispensed prescription medicines without a proper/valid prescription. Suppose a pharmacy which would like to follow the law insists on a prescription. In that case, the pharmacy offers a whole variety of excuses from the clients/patients like “I forgot to bring the prescription”, “The doctor is my relative and has told me verbally what to take”, or “This is the first time anyone has asked me for a prescription”. “I know my medicine. I have been taking them for years.” Why does one need a prescription for an antibiotic? You want me to go all the way home and bring the prescription?”. All pharmacies give – why can’t you? Don’t worry, I won’t hold you responsible” My friend recommended the medicine for me since he found it effective for the same condition” “We cannot afford to go to a doctor again to get a prescription.”

Because there are no complaints from people! People will complain if they are asked for prescriptions. Since they are often not asked, people do not complain”. Going to a doctor takes time and involves paying fees; many clients also see the person at the pharmacy as competent to recommend medicines. All these callous attitudes has grown the problem bigger and bigger.

International Position

In Singapore, prescription drugs are strictly regulated, and it is illegal to obtain them without a valid prescription from a licensed doctor. This is in stark contrast to some places like India, where it may be more common to purchase certain medications over the counter (OTC) without strict enforcement of prescription requirements.

In the United States, prescription drugs are also strictly regulated. You cannot legally obtain prescription medications without a valid prescription from a licensed healthcare provider, such as a doctor, nurse practitioner, or physician assistant. This applies nationwide and is governed by both federal and state laws.

In Australia, prescription drugs are also strictly regulated, and you cannot legally obtain them without a valid prescription from a licensed healthcare professional, such as a doctor, nurse practitioner, or dentist. The regulations in Australia are like those in countries like Singapore and the United States, where there is a strong focus on ensuring the safe and appropriate use of medications. In the U.S., prescriptions can be obtained through telemedicine services, where patients consult with a healthcare provider remotely. However, even in these cases, a valid prescription is required, and reputable online pharmacies will only fill prescriptions written by a licensed provider.

In the United Kingdom, prescription drugs are also strictly regulated, and you cannot legally obtain them without a valid prescription from a licensed healthcare professional, such as a doctor, nurse, or pharmacist prescriber. Like many other developed countries, the UK has a well-structured system to control prescription-only medicines (POM) to ensure public health and safety.

The problem is deep and chronic; the solution must be found in more than campaigns alone. The effectiveness of proper law, legal consequences, and the role of appropriate regulatory oversight are essential in ensuring pharmacies do not provide prescription drugs like grocery store stuff. If only the sale is stopped legally, then the problem can be solved. The widespread availability of prescription medications without proper oversight poses significant risks to public health in India. Despite existing regulations, poor enforcement has led to a culture where obtaining prescription medicines without a valid prescription has become normalised. This practice has exacerbated issues like adverse drug reactions, increased self-medication, and the growing phenomenon of “prescription drug tourism.” The Indian Pharmaceutical Association (IPA) and health authorities have emphasised the need for stricter control, but the problem persists due to a lack of awareness, regulatory gaps, and the ingrained habit of bypassing legal procedures.

Globally, countries like Singapore, the United States, Australia, and the UK enforce strict rules regarding prescription medications, emphasising the importance of a valid prescription to protect public safety. India’s challenge is not only about stricter enforcement but also about shifting public attitudes toward responsible medication use. A comprehensive approach—strengthening regulations, increasing public awareness, and ensuring consistent enforcement—is necessary to curb the dangerous practice of dispensing prescription drugs without proper medical supervision. Addressing this issue is crucial to safeguarding health and preventing the further escalation of drug misuse and its consequences.

References:

Indian Pharmaceutical Association. (n.d.). The Serious Problem of Availability of Prescription Medicines without a Prescription in India & Possible Solutions. In Indian Pharmaceutical Association (pp. 1–3). https://ipapharma.org/wp-content/uploads/2019/02/reminder-letters-to-prime-minister-and-minister-of-health-family-welfare-regarding-dangers-of-easy-availability-of-prescription-medicines-without-a-prescription-14.11.2017.pdf