Drugs Control department said drugs for disorders like ADHD cannot be regulated because they are being imported.
Drugs like modafinil and amphetamine drug products marketed as Adderall, are being sold on e-commerce platforms like Indiamart and some pharmacies without prescriptions despite not being over-the-counter (OTC) drugs, placing consumers at risk.
According to the International Narcotics Control Board, amphetamine falls under Schedule II restricted drugs, while Modafinil falls under Schedule IV restricted drugs under the Controlled Substances Act (CSA). Therefore, they must be purchased with a prescription. In contrast, over-the-counter drugs like Benedryl (diphenhydramine) require a prescription on e-commerce platforms like Amazon.
Another drug, melatonin is being sold without any prescription online. The drug is not an OTC in countries like The United Kingdom. However, there are no laws regarding regulation of melatonin in India.
A Christ University student who consumes melatonin gummies said, “I used to sleep around 4:00 a.m. every night, but these gummies make me fall asleep sooner. I sleep like a baby by midnight now. Sleeping early has also helped me feel more energized during the day.”
She said, “I prefer these flavoured gummies over the bitter pills that you have to swallow. I face some difficulties buying melatonin pills in stores, but one or the other usually provides it over-the-counter.”
Melatonin is available without a prescription on Amazon and has been bought by thousands.
Melatonin aids sleep and is prescribed for the management of jet lag and other sleep disorders. Modafinil, on the other hand, has wakefulness-promoting agents and reduces extreme sleepiness. It is prescribed to help people who have narcolepsy. Whereas Adderall is a combination medicine used to treat attention deficit hyperactivity disorder (ADHD).
However, if someone tries to purchase drugs like modafinil online, they will be instantly directed to the checkout page. This contrasts with the guidelines for purchasing prescription drugs, which say the customer should be directed to a page asking for their prescription.
A pharmacist in Vijayanagara, while handing out an anti-depressant that aids sleep to a customer, said, “We do not usually give it without a prescription. Next time, please bring one with you or we will not provide the drug.”
Dr. Surya of Reroot Psychiatric Clinic said, “Melatonin affects circadian rhythm, which helps people whose sleep cycle is disrupted. It is a comparatively less harmful drug than most available without a prescription online. However, its dosage should not be more than three – 10 mg.”
He said, “Many of my patients from the IT (Information Technology) industry whose screen times have been increased due to working from home have complained about having difficulty sleeping.” These people are more prone to consume medicines like melatonin. “Self-treating yourself with medicines like melatonin and modafinil also sometimes causes some other issue that you might have to go undiagnosed,” he said.
Assistant Drug Controller of the Drugs Control Department said, “All NDPS (Narcotic Drugs and Psychotropic Substances) are regulated and checked regularly, but drugs like Adderall are being imported and not manufactured in India. Therefore, there are issues in regulating them.”
He said, “Although these drugs should not be sold without prescriptions, we are not able to regulate them online when they come from licensed companies from abroad or places like Delhi. We follow the Drugs and Cosmetics Act; while these drugs should not be sold over-the-counter, they do not come under Schedule H1 drugs that the Act seeks to regulate.”
Dr. Surya added, “Medicines should be regulated, but people using them should also be cautious of what they are consuming.” He added, “Self-treating is an issue. People should seek help from doctors and psychiatrists instead of self-treating because only they know what part of the problem they are treating with medications. Follow-ups are equally important.”
Dr. Raunak from Uttar Pradesh University of Medical Sciences said, “These drugs should be regulated as they have side effects ranging from minor to severe, including drowsiness, weight loss, and respiratory distress. It is highly unethical to sell such drugs online without a prescription from a doctor or psychiatrist. Whoever is selling it without a prescription should have their licenses cancelled, and the authorities should look into the matter.”
Gopal, a legal adviser, said, “Selling such drugs without a prescription is highly unethical. Pharmacies or e-commerce platforms selling these drugs without prescriptions can lead to the cancellation of a license or a penalty being imposed. There should be committees set up by concerned authorities to make rules regarding the matter.” He said, “There are also laws in place, but they lack implementation for the same. There is a need to ensure and implement already present laws to regulate such drugs being sold online.”
