In order to curb misuse and illegal sale of certain restricted drugs, the centre on September 8 proposed changes to the Drugs Rules, 1945. The amendment would tighten control over how Schedule H, H1 and X drugs are to be sold across the country. These categories include medicines that require a valid prescription and carry a high risk of misuse if sold freely.
The Union Health Ministry recommends CCTV surveillance mandatory at medical stores that sell these drugs. The cameras at the point of sale would make it harder for pharmacies to hand out these medicines without a valid prescription, and easier for regulators to trace violations when they happen.
Schedule H covers a wide list of prescription-only medicines, currently over 500 drugs, ranging from common antibiotics to other therapeutic drugs that should not be sold without a doctor's prescription.
Schedule H1 is a smaller, more tightly watched subset of around 46 drugs, largely made up of third- and fourth-generation antibiotics, newer-generation fluoroquinolones, and first- and second-line anti-tuberculosis drugs. These carry a mandatory red-bordered warning label with an "Rx" symbol, and pharmacists must log the patient's details, the prescribing doctor's contact information, and the quantity sold in a register, retained for at least three years.
Whereas, Schedule X covers narcotic and psychotropic substances which require even stricter recordkeeping and controls on sale.
The centre’s move comes after long-standing concerns about unauthorised access to and sale of these restricted drug categories. Despite existing prescription rules, enforcement at the retail level has remained patchy, contributing to over-the-counter sales of medicines that are meant to be tightly controlled.
The proposal went through India's formal regulatory process, starting with deliberations at the Drugs Consultative Committee (DCC), before being reviewed by the Drugs Technical Advisory Board (DTAB), the country's apex technical body on drug regulation. The DTAB has recommended its approval.
How self-medication has become a problem
While a few go to doctors for minor ailments even today, many people believe that over-the-counter (OTC) medicines do the job for them. According to the reports, India is one of the countries with the highest burden of antimicrobial resistance globally, and easy OTC access to antibiotics is repeatedly cited as a key reason.
One report notes that unrestricted OTC availability of antibiotics has led nearly three-quarters of Indians to self-medicate. With more than 800,000 retail pharmacies spread across the country, medicines, including those needing a prescription, remain widely accessible with or without one.
Indians are also among the world's biggest consumers of antibiotics, with over 12 billion standard units sold in the country in 2020 alone, according to research published in the Bulletin of the World Health Organization.
This isn't the first time the centre is trying to regulate the retail antibiotic trade. In 2014, authorities separated Schedule H1 from Schedule H specifically to bring stricter controls on second- and third-generation antibiotics, requiring pharmacists to maintain a separate sales register and retain prescription copies. But multiple studies since have found that pharmacists continue to dispense antibiotics based on symptoms alone, without insisting on a valid prescription.
The CCTV mandate appears to be an attempt to plug that enforcement gap with a technological check.
What to expect from this amendment
If implemented, this change would tighten monitoring of how Schedule H, H1 and X drugs move through the supply chain, and reduce instances of these drugs being sold without prescriptions.
According to the ministry, CCTV surveillance will also bring greater transparency and accountability to pharmacies, reinforcing existing public health safeguards.
The amendment is currently in draft stage. The Ministry has opened it up for public consultation, inviting objections and suggestions from stakeholders before it is finalised. Feedback can be submitted to the Under Secretary (Drugs) at the Ministry of Health and Family Welfare, either by post or via email.