CPI seeks legal guidelines for regulating online medicine sales

Demands have been raised for the government to introduce legally binding guidelines for online medicine sales (e-pharmacies) in India, including strengthenin...

What Happened

Demands have been raised for the government to introduce legally binding guidelines for online medicine sales (e-pharmacies) in India, including strengthening the Drug Control Administration and State Pharmacy Councils and introducing strict digital monitoring mechanisms.
As of May 2026, no specific e-pharmacy legislation has been notified in India — the Draft E-Pharmacy Rules, 2018, proposed under the Drugs and Cosmetics Act, 1940, remain unfinalized in the Official Gazette.
A nationwide shutdown of retail medical stores was called for 20 May 2026 by the All India Organisation of Chemists and Druggists (AIOCD), representing approximately 1.24 million chemists, protesting the unregulated growth of online pharmacy platforms.
Key concerns cited include: AI-generated prescriptions with fabricated credentials used to dispense controlled substances, discounting practices by large corporate-backed platforms that brick-and-mortar pharmacies cannot match, and absence of mandatory prescription verification by e-pharmacies.
The Central Drugs Standard Control Organisation (CDSCO) has been reviewing concerns raised by retail pharmacist associations, even as at least 12 state-level associations distanced themselves from the shutdown.

Static Topic Bridges

Drugs and Cosmetics Act, 1940 — The Foundation of Drug Regulation

The Drugs and Cosmetics Act, 1940 is the primary legislation governing manufacture, distribution, and sale of drugs and cosmetics in India. Enacted during the British period, it has been significantly amended post-independence, most recently through the Drugs and Cosmetics (Amendment) Act, 2008. The Act defines what constitutes a "drug," prescribes licensing conditions for manufacturers, wholesalers, and retailers, and prohibits the sale of specified drugs without a prescription from a registered medical practitioner.

Rule 65 of the Drugs and Cosmetics Rules, 1945 (made under the Act) requires that a licensed retail pharmacist physically verify and retain prescriptions before dispensing Schedule H, H1, and X drugs (habit-forming, antibiotics requiring prescription, and narcotic/psychotropic substances).
Schedule H drugs cannot be sold over the counter without a prescription; Schedule H1 (introduced in 2013) applies to specific antibiotics and other drugs where additional record-keeping is required.
Schedule X drugs — narcotic and psychotropic substances — require additional compliance under the Narcotic Drugs and Psychotropic Substances (NDPS) Act, 1985.
Enforcement of the Drugs and Cosmetics Act is a concurrent responsibility: CDSCO operates at the central level for licensing manufacturers and regulating new drugs, while State Drug Controllers enforce retail/wholesale licensing and conduct inspections.
As of May 2026, e-pharmacies lack a distinct licensing category under the Drugs and Cosmetics Act — they operate (or should operate) under existing retail pharmacy licensing rules, creating an enforcement ambiguity.

Connection to this news: The absence of notified e-pharmacy rules means online platforms technically must comply with the same Schedule H/H1/X prescription requirements as physical pharmacies — but enforcement is practically impossible without a digital prescription verification mechanism, which is at the core of the regulatory demand.

Central Drugs Standard Control Organisation (CDSCO)

The CDSCO is the national regulatory authority for pharmaceuticals and medical devices in India, functioning under the Directorate General of Health Services in the Ministry of Health and Family Welfare. Its mandate covers approval of new drugs, clinical trials, import licenses, and central market authorisation.

CDSCO is headed by the Drug Controller General of India (DCGI).
CDSCO's primary functions: approval and regulation of new drugs (not manufactured and marketed in India before); licensing of manufacturers of large-volume parenterals and blood products; regulation of medical devices and diagnostics; control of import of drugs and cosmetics.
In February 2023, CDSCO issued show-cause notices to 20 online pharmacies — including major e-commerce platforms — for alleged sale of prescription drugs without valid prescriptions.
State Drug Controllers, not CDSCO, are responsible for retail pharmacy licensing and enforcement — creating a jurisdictional gap for e-pharmacies that operate across state borders through a single digital platform.

Connection to this news: The demand to strengthen Drug Control Administration and State Pharmacy Councils reflects the existing enforcement gap — e-pharmacies span multiple state jurisdictions but face only fragmented state-level oversight, with no central digital monitoring mechanism.

Draft E-Pharmacy Rules, 2018 and the Regulatory Gap

In August 2018, the Ministry of Health and Family Welfare issued Draft Rules to amend the Drugs and Cosmetics Rules, 1945 to create a specific licensing and regulatory framework for e-pharmacies (via GSR 817(E)). The draft rules were released for public comment but have not been notified as of May 2026 — leaving a statutory vacuum of over seven years.

The Draft Rules proposed: mandatory e-pharmacy registration (separate from retail pharmacy license); customer grievance redressal mechanism; data localisation requirement (no patient data to be stored or mirrored outside India); prohibition on advertising drugs; no sale of drugs covered under Schedule X (narcotics), Schedule H1 (specific antibiotics requiring record), or blood and blood products.
Digital prescription verification and pharmacist oversight at the point of online dispensing were proposed as mandatory conditions.
The Drugs, Medical Devices and Cosmetics Bill, 2023 — which sought to consolidate and modernise the 1940 Act — included an e-pharmacy licensing regime but did not pass before the end of the previous Lok Sabha session.
The Delhi High Court, in November 2023, gave the government an eight-week deadline to frame an e-pharmacy policy — a direction that remains unimplemented as of the date of this article.

Connection to this news: The continued absence of notified e-pharmacy rules — despite a draft circulated in 2018, a Bill in 2023, and a High Court directive in 2023 — forms the precise regulatory vacuum that allows concerns about AI-generated prescriptions and unmonitored Schedule H drug sales through online channels to persist.

Telemedicine Practice Guidelines, 2020

The Ministry of Health and Family Welfare issued Telemedicine Practice Guidelines on 25 March 2020, providing the first consolidated regulatory framework for remote medical consultation in India. These guidelines are legally binding on Registered Medical Practitioners (RMPs) and are embedded in the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002.

The guidelines categorise drugs that RMPs may prescribe via telemedicine: List O (over-the-counter drugs, prescribable via any telemedicine mode), List A (prescribable via audio-visual consultation), List B (prescribable only via in-person follow-up), and Prohibited List (drugs that cannot be prescribed via telemedicine — including habit-forming, narcotics, and specified psychotropics).
Prescriptions generated via telemedicine must carry the RMP's name, registration number, and the platform through which the consultation occurred.
AI-generated prescriptions — not issued by a registered human medical practitioner — are not valid under any Indian law or guideline; dispensing drugs against such prescriptions constitutes a violation of both the Telemedicine Guidelines and the Drugs and Cosmetics Act.
RMPs are required to complete an online telemedicine training course within three years of the 2020 notification.

Connection to this news: The concern about AI-generated prescriptions being used to procure controlled drugs online highlights that the Telemedicine Guidelines' validity requirements are not being enforced by e-pharmacy platforms at the point of dispensing — closing this gap requires both a notified e-pharmacy regulatory framework and interoperability with the National Medical Register to verify prescribing practitioners.

Key Facts & Data

Retail medical stores in India: approximately 1.24 million (AIOCD estimate).
Draft E-Pharmacy Rules issued: August 2018 (GSR 817(E)) — unnotified as of May 2026.
CDSCO show-cause notices to online pharmacies: 20 platforms, February 2023.
Telemedicine Practice Guidelines notified: 25 March 2020.
Drugs requiring prescription under Drugs and Cosmetics Rules: Schedule H, H1 (introduced 2013), and Schedule X (narcotics/psychotropics — also governed by NDPS Act, 1985).
Primary enforcement authority for retail pharmacy licensing: State Drug Controllers (not CDSCO).
CDSCO headed by: Drug Controller General of India (DCGI), under Ministry of Health and Family Welfare.
Delhi HC direction on e-pharmacy policy: November 2023 (eight-week deadline — unimplemented as of May 2026).
Drugs, Medical Devices and Cosmetics Bill, 2023: included e-pharmacy regime; did not pass.