The Indian government is taking decisive action to clamp down on online advertisements for high-risk medicines in a major regulatory overhaul aimed at curbing self-medication, unsafe drug sales, and rising antimicrobial resistance. This move comes amid growing concerns about misleading claims in digital advertisements that are distorting patient behavior across the country.
Closing Regulatory Loopholes
According to official documents reviewed by Mint and two government officials familiar with the matter, the draft proposal currently before the Drugs Controller General of India (DCGI) seeks to amend the Drugs and Cosmetics Rules, 1945. The key change involves making the prohibition of advertisements for high-risk Schedule G, H, H1, and X drugs a mandatory condition for all drug licenses.
Currently, drug licenses do not explicitly ban advertising, creating a significant regulatory gap that has been exploited by various online platforms. The proposed amendment would close this loophole by explicitly banning all forms of drug advertising on digital platforms for these controlled medications.
Comprehensive Ban Across All Channels
The government's plan represents a sweeping overhaul of current regulations. "This proposal seeks to ban all forms of drug advertising on online platforms—under the plan, the seller, wholesaler, or distributor will be prohibited from advertising these drugs across any channel," explained one official who spoke on condition of anonymity.
The official further clarified that the proposal will first go to the Drugs Technical Advisory Board (DTAB) for discussion before final amendments are made to the Drugs Rules, 1945. The government is also intensifying its monitoring of online drug sales to ensure companies adhere strictly to existing regulations.
Schedule G, H, H1 and X drugs include potent antibiotics, psychotropic drugs, narcotics, and hormonal therapies that come with strict labeling, storage, and record-keeping requirements. These medications cannot be legally sold without a doctor's prescription under current Indian law.
Growing Concerns and Expert Reactions
Medical experts have welcomed the government's initiative, pointing to a surge in misleading claims in online advertisements that are dangerously influencing patient behavior. Doctors consulted by Mint emphasized that these advertisements encourage self-medication, mask symptoms, delay proper diagnosis, and contribute to the growing problem of antimicrobial resistance.
Dr. Ranjan Shetty, medical director at SPARSH Group of Hospitals in Bengaluru, described the government's move as "timely and essential." He stressed that the uncontrolled spread of claims on digital platforms is severely harming public health and called for making digital platforms jointly accountable for blocking advertisements of high-risk Schedule H, H1, and X drugs.
Dr. Shetty emphasized the need for a structured, technology-enabled framework that includes establishing a centralized registry for approved promotions and ensuring strong coordination between regulatory bodies like the Central Drugs Standard Control Organisation and state regulators.
Industry Response and Legal Framework
The proposed amendment will broadly target any person or licensee involved in the sale or distribution of specified high-risk drugs. This means all entities—from online marketplaces and e-commerce giants to licensed e-pharmacies—will be subject to the new restrictions on advertising controlled medications.
Industry representatives have begun responding to the proposed changes. Prashant Tandon, CEO of Tata 1mg, stated that his platform already follows strict guidelines. "There is no advertisement for any prescription medicines on Tata 1mg. In some platforms, if some companies are advertising prescription medicines, there are clear provisions for the regulators to act," Tandon noted.
An executive at Netmeds, speaking anonymously, claimed the company is "fully compliant" with all laws governing drug sales and advertisements. However, queries sent to numerous other platforms including IndiaMART, Amazon, Flipkart, MediBuddy, Practo, Apollo Pharmacy, and Swiggy remained unanswered at the time of reporting.
The matter was formally discussed at a meeting of the Drugs Consultative Committee (DCC) chaired by DCGI on 17 November, indicating the seriousness with which the government is treating this issue.
Global Context and Legal Perspectives
Legal experts highlight that the current regulatory framework consists of two main acts: the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, and the Drugs and Cosmetics Act, 1940. While the DMRA provides a legal framework to restrict misleading advertisements of certain drugs and diseases, it is limited in scope and often inadequately enforced.
According to legal specialist Narsana of Khaitan & Co, ill-intentioned players are exploiting gaps in the current framework. "They creatively structure claims in ways that may be detrimental to public safety," Narsana explained, emphasizing that the DCA's "blind spot" and lax implementation of the DMRA have enabled problematic advertising practices to flourish.
Internationally, countries approach this issue differently. Nations in Europe and Singapore prohibit direct-to-consumer advertising for prescription medicines, restricting communication to healthcare professionals. While the United States permits DTC advertising, it mandates rigorous FDA requirements for safety disclosures and data transparency.
Rajiv Singhal, general secretary of the All India Organization of Chemists and Druggists (AIOCD), which represents approximately 1.24 million members, confirmed that several websites have been actively advertising medicines, underscoring the need for stricter regulation.
The government's move represents a significant step toward aligning India's drug advertising regulations with global best practices while addressing the unique challenges posed by digital platforms and evolving patient behaviors in the Indian healthcare landscape.
