Gaps in enforcing prescription rules continue to raise concerns over the sale of restricted medicines
Despite regulations requiring prescriptions for certain categories of medicines, concerns over the sale of prescription-only drugs without valid prescriptions continue to persist. Medicines listed under Schedules H, H1 and X of the Drugs Rules, 1945, are not permitted to be sold over the counter (OTC) without a valid prescription, but gaps between regulation and enforcement continue to raise questions.
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For consumers, the process can sometimes appear simple. A person may walk into a pharmacy and ask for a medicine by its brand name. In some cases, pharmacists may not ask for a prescription.
The Centre has recently tightened regulations for medicinal formulations containing high levels of alcohol. Under the amended rules, formulations containing more than 12% v/v ethyl alcohol in quantities exceeding 30 ml will no longer enjoy the earlier exemption under Schedule K. These medicines have now been brought under Schedule H1 and can be sold only against a prescription from a registered medical practitioner.
The new rules also require stricter record-keeping for the sale of such medicines.
While the regulatory change addresses a specific category of medicines, it has also renewed attention on whether existing prescription requirements for medicines under Schedule H, Schedule H1 and Schedule X are being strictly followed at pharmacies in Guwahati.
Under the Drugs Rules, medicines placed under these schedules are not meant to be sold like ordinary over-the-counter medicines. They require a prescription from a registered medical practitioner.
Schedule H1 medicines also require additional records to be maintained by sellers.
However, consumer experiences suggest that accessing certain prescription-only medicines may not always require a prescription.
Speaking to GPlus, a Guwahati resident admitted that they sometimes buy antibiotics directly from pharmacies without consulting a doctor.
“I sometimes take antibiotics directly from the pharmacy without a prescription. If I directly quote the brand name, the pharmacist does not ask for a prescription,” the consumer said.
The statement highlights concerns over the availability of prescription-only medicines without medical consultation and the practice of self-medication.
A doctor at Gauhati Medical College and Hospital (GMCH), speaking to GPlus, said the over-the-counter (OTC) sale of medicines under Schedule H, Schedule H1 and Schedule X must be strictly prohibited.
“Over-the-counter (OTC) sale of any drug which falls under Schedule H, Schedule H1 and Schedule X must be strictly prohibited,” the doctor said.
The doctor also pointed to the growing concern over antibiotic resistance.
“I have seen patients who have developed antibiotic resistance because they regularly take antibiotics from pharmacies without any prescription. Patients often buy antibiotics directly from pharmacies without our prescription. They do not care about the dosage, and this negatively affects their bodies,” the doctor said.
Antibiotics are required to be taken in the correct dose and for the prescribed duration. However, when people buy them directly from pharmacies and take them without medical advice, they may take the wrong medicine, the wrong dose, or stop taking the medicine once they start feeling better.
The doctor further said that the high price of certain prescription medicines could create an incentive for their unauthorised sale.
“As prescription-only medicines are of high value, pharmacists sometimes give them to patients without a prescription to increase their sales,” the doctor said.
What the rules require
The enforcement of prescription rules involves both regulatory authorities and pharmacies.
Speaking to GPlus, Guwahati Drug Inspector Abhinash Deka said inspections are carried out whenever the department receives a complaint.
“We go for a routine inspection whenever we get any complaint. Though, as per the Act, we must visit any pharmacy store every three years,” Deka said.
According to him, the department checks the records maintained by pharmacies during inspections.
“We check whether the purchase and sales registers are maintained or not for prescription-only drugs. If any foul play is found, we note that and send it to the Drug Controller. The Drug Controller further takes action, if required,” he said.
The requirement to maintain records is particularly important for medicines placed under stricter regulatory categories.
For Schedule H1 medicines, pharmacies are required to maintain records related to their sale. These records help regulators track the purchase and sale of such medicines and identify possible violations.
The gap between rules and reality
The rules are clear: medicines under Schedules H, H1 and X cannot be sold over the counter without a valid prescription. Yet, consumer experiences and concerns raised by doctors point to the gap that can exist between regulation and enforcement.
The issue is also linked to awareness. Many consumers may not know which medicines require a prescription. Some may believe that if a medicine was prescribed to them earlier, they can continue buying it whenever they need it.
Others may rely on pharmacists or previous prescriptions instead of consulting a doctor.
However, previous use of a medicine does not replace the requirement for a valid prescription where one is required under the rules.
The issue, therefore, is not only about whether a customer can purchase a medicine from a pharmacy. It is also about whether the rules governing the sale of prescription medicines are being followed in practice.
The latest regulatory change on high-alcohol-content formulations highlights the importance of controls over medicines that require professional oversight.
In Guwahati, the Drug Inspector said inspections and record checks are carried out, while a doctor at GMCH warned about the risks of self-medication, particularly with antibiotics.
At the same time, a consumer’s admission that antibiotics can sometimes be bought by simply quoting a brand name raises questions about how effectively prescription requirements are being followed at pharmacy counters.
For consumers, the rule remains simple: medicines classified as prescription-only should not be bought or sold without a valid prescription.
For regulators, the challenge is to ensure that these requirements are followed in everyday transactions across the city.