E-Pharmacy In India - Issues And Challenges

Author: LawSphereX

Category: General Law

Published: 2026-08-23T19:35:55.135Z

Updated: 2026-08-30T07:05:00.678Z

E-PHARMACY IN INDIA: ISSUES AND

CHALLENGES

Bilish Chakewarite, LL.M. (Corporate Laws), School of Law, Galgotias University, Greater Noida, Uttar Pradesh.

ABSTRACT

Online pharmacies, or e-pharmacies, have transformed the pharmaceutical sector by providing customers with cost savings, accessibility, and convenience. But even with its quick expansion, a number of problems and difficulties still exist. The sale of pharmaceuticals without a prescription from a licensed medical professional is prohibited by the “Drugs & Cosmetic Act of 1940’’ and the’’ Drugs & Cosmetic Rules of 1945’’, which regulates nation's drug distribution and sales. E-pharmacy has a number of drawbacks, such as the inability to guarantee the quality of medications, the lack of adequate facilities for storing medications, the dangers of self-medication, the possibility of reordering medications based on the same prescription, and the confusion that can occur when drug names are confused with those of the companies that manufacture them.

The Indian cabinet has schemed the “D & C (Amendment) Rules 2018’’, to regulates pharmacy but has not yet been notified. The country waits for the federal government to decide whether to regulate the sale of drugs online. The problems and difficulties associated with e-pharmacy in India were discussed in this research. Keywords: D&C (Amendment) Bill, 2018, e- pharmacies, and the “Drugs & cosmetic Act 1940’’and “Drugs &Cosmetic Rules of 1945’’.

I.

INTRODUCTION

E-commerce, or electronic commerce, is a significant business with a promising future. India's online pharmacy sector is estimated to attain a value of $ 325 billion by 2030, ignited by 500 million consumers enhanced due to internet accessibility, particularly in non-metropolitan regions. At the of 2026, more than 1. 18 billion individuals are going to possess smart phones, facilitating digital purchase. Non metropolitan regions are going to have more than 60% of demand, especially from developing urban towns. The Indian online commerce sector is estimated to increase at COMPOUND-GROWTH- RATE (CAGR) of 27, with a value of $ 163 billion by 2026. 1 TABLE 1: E-COMMERCE on India Brand Equity Foundation (www. ibef. org)2 India is home to world's largest distributor in off-patent medicines well known for its reasonably prices.

The Indian pharma sector continued rising in April 2025, achieving a strong annual growth of 7. 8%. 3 The Indian pharma sector business comprises various key categories as, generic drugs, OTC medications, vaccines etc. India accounts for more than 8% of the

1 ECOMMERCE INDUSTRY REPORT 2024.

2 https://www.ibef.org/industry/pharmaceutical-india (last visited 30/03/2025).

Pharma sector continues to thrive, driven by price-led expansion - Times of In https://timesofindia. indiatimes. com/business/india-business/pharma-sector-continues-to-thrive-driven-by-priceled-expansion/articleshow/121056701. cmsdia. (last visited 05/05/2025). global API (Active Pharmaceuticals Ingredient) market as India has almost 500 API producers, and has the most pharmaceutical production facilities that comply with US Food & Drug Administration (USFDA) standards. Recent EY FICCI research indicates a burgeoning consensus about the provision of novel therapeutic interventions for patients. By the end of 2030, the Indian pharma sector is expected to be 30 billion. At the same time, it was predicted that the global pharmaceutical market would reach a value of over trillion by 2023.

The epharmacy framework was sparked by COVID-19, and the Indian pharmaceutical business was about to undergo a shift. Major online platform has entered the race to expand, capture digital pharmacy market, anticipated to increase sevenfold to $ 2. 7 billion by the end of 2023. With the high demand and consumer backing, e-pharmacies like “Tata -1mg, Med-life, Pharm- Easy,’’ are striving for substantial share of India's 42 billion $ pharma sector. These online pharmacy companies' distribution and commercial strategies stand in stark contrast to the current pharmacy network. Despite the benefits of the e-pharmacy industry, India has regulatory barriers. The legality that internet pharmacies concerning the sale of prescription medications has emerged as a pertinent issue.

They are doing operations legitimately, akin to any other e-commerce enterprise, in accordance with the Information Technology Act of 2000. In the lack of specific restrictions, the owners of the online pharmacy abide by the guidelines established for Indian retail pharmacies. The Drugs & Cosmetics Act does not differentiate between the sale of items online and in physical retail establishments. The Government had released draft Rules via G. S. R. 817 (E) dated 28th August 2018 for change to the medications and Cosmetics Rules, 1945 to incorporate provisions relating to the regulation of the sale and distribution of medications through e-pharmacy. Nevertheless, these have yet to be published in the Officially.

Moreover, medical business expresses concern that the “D&C Act 1940’’, is of pre-independence era, has become obsolete and requires amendment to align with the expectations of the industry, customers, and the Government. Additionally, the Central Government has recently amended the clauses in the 4’’Draft Bill, 2022” concerning online pharmacy through a new legislation. The 5Draft Pharmacy Bill, 2022 submitted for consultation of ministry and for public and stakeholder feedback.

4 Draft Drugs, Medical Devices and Cosmetics Bill, 2022.

5 Drugs, medical devices and cosmetics bill, 2022; India Times/ Drugs, Medical Devices and Cosmetics Bill, 2022; All you want to Know (indiatimes. com) II. INDIA'S REGULATORY FRAMEWORK FOR E-PHARMACY: Since the regulations governing physical pharmacies also apply to internet pharmacies, there is currently no regulatory framework in place to monitor the sale of medicines digitally in the nation. “The Drugs and Cosmetics Act 1940 do make difference among sale of medicines online and offline. Indian pharmacy law contains a set of guidelines; however, it makes clear difference between sale of online and offline medicines. The 1940 Drugs Act & the 1945 Drugs Regulations govern the sale of medications in India. To dispense the medication, a registered pharmacist is authorized by the “Drugs &Cosmetics Act of 1948’’.

Laws controlling the sale of medicines in India are covered by the “Drugs Act, 1940, the Drugs Rules, 1945, Pharmacist Act, 1948, while e-commerce industry is governed by the I. T Act, 2000. III. THE PRESENT STATE OF ONLINE PHARMACIES: The IT Act of 2000 governs e-commerce, whereas the D& C Act of 1940, the D& C Rules of 1945, the Pharmacist Act of 1948, and the D&C Act of 1940 all govern the selling of medications in India. However, neither permits nor prohibits the online sale of medications in India under the aforementioned laws. The recent digital expansion of the online pharmacy sector in India is not addressed by the precolonial legislation. In India, no specific laws or guidelines have been created for online pharmacies.

The 1940 Drug and Cosmetic Act and the 1945 Regulations have provisions to ensure the quality and standards of the medications, but they are incompatible with internet pharmacies. Several of these clauses include: • Only licensed pharmacies with current retail licenses are permitted to sell medication. • It is forbidden to sell the prohibited substances both online and offline. • Only with a licensed medical practitioner's prescription can a registered practitioner sell any medication. • Only a legitimate prescription from a licensed medical professional is required to sell medications prescribed under schedules H, H1, and X of the medicines and cosmetic laws.

To control the sale of pharmaceuticals medicine online and availability of authentic medications from reputable websites, the Union Health Ministry released draft regulations on the sale of medications via e-drug retailers in August 2018. The Pharmacy Act of 1948, the D & C Act of 1940, and the D & C Rules of 1945 are now taken up by E-commerce pharmacy in India. However, the I. T Act of 2000 allows the electronic selling of medications prescribed by doctors from Internet pharmacy. The D & C Act 1940, D & C Rules 1945, Pharmacy Act 1948 are now followed by e- commerce in India. IV. PROBLEMS AND DIFFICULTIES WITH INTERNET PHARMACIES: Although the idea of e-pharmacy appears to be very simple and convenient, there are concerns associated with it. Online drug sales are fraught with difficulties and problems.

Below is a discussion of a few of them: LACK OF REGULATORY FRAMEWORK INTER STATE SALE OF DRUGS PROCOURMENT OF MONEY BEFORE DELIVERY PATIENT IDENTITY SCHEDULE X AND H ABUSE OF DRUGS OPPOSITION FROM OFFINE PHARMACY STORES TABLE 2: Challenges of an online pharmacy. 6 v Due to absence of appropriate rules and regulations the online pharmacy market is deterred by many major investors’-pharmacy businesses can only serve in India if they've a physical position because the present medicines and Cosmetic Act authorizations that a druggist must have must have valid license and a registered business in order to dispense and store medicines. v Because there are no set rules governing the interstate sale of pharmaceuticals, medicines that are legal in one jurisdiction may be perceived illegal in other jurisdiction. Such incidents have been reported by the “Mumbai Drug Administration’’.

As online pharmacy firms, continue to grow. Because of this, the industry has a difficult time keeping a careful eye on the sources from which these drugs are supplied or acquired. v Another area where Indian law is unclear is when money is taken before the medication is delivered. Certain laws stipulate that payment should only be received after the medication has been delivered, and online pharmacies may be held legally responsible for breaking these laws since they provide a number of payment options like credit/debit cards and mobile wallets. v Another problem is patient identity because it is very hard to verify the legitimacy of medicine prescription when posted on the online pharmacy portal for drug purchases, and there is no law addressing the sale of medicines to minors or genuine prescriptions. v For Schedule H and X medications, a thorough regulatory structure is required.

These medications, which include antibiotics and pharmaceuticals that cause addiction, can only be dispensed at a pharmacy with a valid prescription in hand. One prescription may be uploaded to the online portal multiple times while using e-pharmacy, which could result in a rise in drug abuse cases. v There has been a significant increase in resistance from physical pharmacies. The offline pharmacy market may be impacted by the alluring discounts and offers made by 6 National Library of Medicine (USA), available at:pmc. ncbi. nlm. nih. gov/article/PMC9804119/ (visited on 15th April 2025). the e-pharmacy industries. The Drug and Cosmetic Act, which states that some medications can be supplied separately with a prescription, has been highlighted by many associations. E-drug retailers' home delivery of drugs violates this rule. V.

THE WAY FORWARD: Since e-pharmacies may provide medications at low prices and are readily accessible in India, it is imperative that strict rules be put in place to regulate the e-pharmacy industry and protect consumers' interests. • The e-pharmacy industry should have a rigorous licensing system. For example, e-pharmacies may be given a logo or an enrolment number that would enable customers to verify the legitimacy of the online platform. • Patient data protection should be digitally kept in a safe manner to avoid information misuse. • To effectively serve a substantial section of the population in both urban and rural areas that have unmet medical requirements, e-pharmacies should be linked to government aided health programs. VI.

CONCLUSION

The market for online pharmacies has already delved far into the internet sales of medications, and based on current data and trends, it appears that e-pharmacies have completed their experimental stage and are now a reality. Furthermore, there have been historical instances where the development of technology has resulted in modifications to the relevant regulations. The future of e-pharmacies is unclear due to the new proposed bills for 2018 and 2022. One argument is that e-pharmacies are prohibited from displaying pharmaceuticals on their websites due to their usage of the marketplace model and absence of a registered pharmacist license, as the legislation only allows license holders to do so. Nevertheless, e-pharmacies that employ the marketplace model claim that they are only serving as intermediaries between buyers and sellers in compliance with the I. T Act of 2000.

Then the problem arises: is it acceptable for them to have drug displays on their website? The pre-independence laws need to be modified by the government to address these problems. The government should develop a clear plan and enact specific regulations to address the current issues such as prescription pharmaceuticals, interstate sales, etc. , and encourage the expansion of India's online pharmaceutical business rather than contemplating a ban on online pharmacies.

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