Even after nearly seven years since the first draft rules were released, India still lacks a final regulatory framework to govern online medicine sales. The Central Government has not enacted any binding regulation on e-pharmacies, despite including relevant provisions in the proposed Drugs, Medical Devices and Cosmetics Bill, 2023. Responding in Rajya Sabha on July 22, Minister Anupriya Patel confirmed that the draft rules, issued in August 2018, remain under review. Meanwhile, India’s e-pharmacy industry has grown rapidly, raising concerns over patient safety, data privacy, and sale of unregulated drugs. Pharmacy traders have consistently opposed online medicine sales, leading to ongoing court cases demanding regulatory action.

Key Highlights

Draft rules remain unenforced

• Draft e-pharmacy rules were released in August 2018 for public feedback.

• Key provisions included registration, inspections, data privacy, complaint handling, and ad bans.

• No final regulation has been passed till date.

No update from Centre despite court pressure

• Delhi High Court has asked the Centre for updates on e-pharmacy rules multiple times.

• In May 2024, the Centre admitted it had not framed the policy yet.

• Petitions to ban online medicine sales are now being heard on merit.

E-pharmacy sector continues to grow

• Industry is valued at $1.4 billion, growing at ~20% annually.

• Only 5% of operations are considered organized e-pharmacy.

• Tech evolution and ecommerce penetration have outpaced regulations.

Trader bodies and regulators oppose unregulated sales

• Groups like SCDA have actively sought court action against e-pharmacies.

• Central Drugs Standard Control Organization (CDSCO) has urged states to act on violations.

• Traders argue that online sales violate the current Drugs and Cosmetics Rules, 1945.

India’s digital pharmacy sector is expanding fast, but the legal vacuum around its operations continues. With risks related to patient safety, counterfeit medicines, and data misuse, finalizing a dedicated regulatory framework has become urgent. Until then, industry growth will remain shadowed by uncertainty and legal challenges.