E-Pharmacies in India: Regulation challenges and Industry concerns

This response was prompted by show-cause notices issued to various firms engaged in online drug sales on February 8th and 9th, 2023.

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Medicine Laptop computer Online
Picture: Pixabay

Last Updated on August 14, 2023 by The Health Master

E-Pharmacies in India

The Union Ministry of Health and Family Welfare has addressed the growing concerns surrounding e-pharmacies in India.

In response to show-cause notices issued by the Central Drugs Standard Control Organisation (CDSCO) earlier this year, most e-pharmacies have claimed to serve as intermediaries, connecting users with licensed pharmacies.

E-Pharmacies as Intermediaries:

The Ministry’s communication highlights that e-pharmacies have predominantly defended their operations as platforms that facilitate connections between users and licensed pharmacies.

Laptop computer Online medicine
Picture: Pixabay

This response was prompted by show-cause notices issued to various firms engaged in online drug sales on February 8th and 9th, 2023.

Draft Rules and Regulatory Ambiguity:

While the Ministry briefly mentioned draft rules concerning online medicine sales, these draft rules were released nearly five years ago.

The Ministry did not provide updates on the current status of these rules or any other plans pertaining to online drug sales.

Minister’s Reply and Regulatory Steps:

Prof. S. P. Baghel, Union Minister of State for Health and Family Welfare, provided a written reply in the Rajya Sabha.

He confirmed that show-cause notices were sent to several firms engaged in online drug sales.

The Minister stressed that these firms assert that their role is limited to providing a virtual platform connecting customers and licensed pharmacies.

Past Efforts to Regulate E-Pharmacies:

To comprehensively regulate online medicine sales, the government previously published draft rules under G.S.R. 817 (E) dated August 28, 2018.

These draft rules aimed to amend the Drugs and Cosmetics Rules, 1945, to include provisions for the regulation of e-pharmacies.

These provisions encompassed areas such as registration, periodic inspections, distribution procedures, prohibition of advertisements, complaint resolution, and monitoring.

Lack of Current Clarity on Draft Rules:

The Minister’s response did not clarify the present status of the draft rules, leaving uncertainty regarding the government’s stance on regulating e-pharmacies.

Regulatory Guidelines Reiteration:

Dr. Rajeev Singh Raghuvanshi, Drugs Controller General (India), issued a circular on March 9th directing state and union territory drug controllers and the Pharmacy Council of India to strictly enforce relevant sections and rules of the Pharmacy Act, 1948, and the Drugs & Cosmetics Act, 1945.

Pharmacy Act and Drugs & Cosmetics Act Implications:

The circular responded to a letter from the Indian Pharmaceutical Association (IPA) that sought strict enforcement of Section 42(1) of the Pharmacy Act and Rule 65 of the Drugs & Cosmetics Act, 1945.

These provisions pertain to online dispensing of medicines and emphasize the physical presence of pharmacists in retail pharmacies, valid prescriptions, and proper supervision.

Industry Opposition and Concerns:

Several industry bodies, including the All India Organisation of Chemists and Druggists (AIOCD) and the Pharmacy Council of India, have raised objections against e-pharmacies.

They contend that e-pharmacies could lead to the sale of spurious drugs, violate regulations, and disrupt traditional pharmacy practices.

Concerns Over Online Pharmacy’s Impact:

The Indian Medical Association (IMA) published a white paper in 2022 expressing concerns over online pharmacies.

The paper cites potential issues such as the substitution of cheaper and counterfeit drugs, undermining doctor-patient confidentiality, adverse drug reactions, drug abuse, and medicolegal liabilities falling on doctors.

Conclusion:

The issue of e-pharmacies in India remains complex, with regulatory challenges and industry concerns playing a pivotal role in shaping the future of online medicine sales.

While e-pharmacies aim to bridge the gap between consumers and licensed pharmacies, regulatory authorities are working to strike a balance between convenience, quality control, and patient safety.

G.S.R. 817(E) dt 28-08-2018 Draft notification Sale of Drugs by E-Pharmacy

Latest Notifications: D&C Act 1940

Latest Notifications: D&C Rules 1945

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