E-Pharmacy in India: A Critical Appraisal
The shift from traditional way of doing business to the flourishing online business platforms or say e-commerce can be attributed to the exponential growth in internet usage. And, the entry of “Online medical apps” in the e-commerce industry in India has raised questions from every nook and corner. As, though technology possessed the attribute of ‘ease of doing business’ it also brought with it the possible threat to “Right to health” which is an invincible right of every citizen of India. However, the question arises whether these online-pharmacy services are safe, harmless and legal? With the absence of any specific law concerning the same, aid can be taken of statutes such as Drug and Cosmetics Act, 1940; Drug (Control) Act, 1950; Information Technology Act, 2000. Nonetheless insufficiency of these legislative instruments has urged the government of India to draft the rules with respect to sale of medicines through online apps, known as “E-Pharmacy Rules, 2018”. This paper will analyse the development of “E-pharmacy” in India and the roadblocks faced by it. Introducing the expanse of “online pharmacies” and very concept in Chapter I, it moves to highlight the negative impact of unregulated online pharmacies on “Right to health in Chapter II. The paper also provides glimpse of international efforts in this field, followed by endeavour made by Indian legislators to monitor online transactions of medicines under Chapter III & IV respectively. Lastly, Chapter V concludes the article by providing some suggestions.
I. Introduction
With the emanation of Digital era, the number of online buyers is increasing and estimated to surpass 120 million in 2018.2 Digitalisation has made the task of consumers easy, as they can buy any product, be it clothing, accessories, electronics with just the click of a button. Stepping up the game of digitalisation in healthcare sector, today one can also find “Online pharmacy apps” which have made buying of medicines hassle-free. The global online pharmacy market which was estimated at 29.4 billion US Dollars is predicted to reach 128 billion US Dollars by 2023.3
What is online pharmacy or e-pharmacy? In absence of any legal definition, an online pharmacy can be defined as “an internet-based vendor that sells medicines and includes both legitimate and illegitimate pharmacies”4; or “one that that operates over the Internet and sends the orders to customers through the mail or shipping companies”.5
II. Interplay between right to health & e-pharmacy
Good health is quintessential for the survival of human beings. As per the “World Health Organization” (WHO), ‘health’ is defined as “a state of complete physical, mental and social well-being and not merely the absence of disease”.6
The Constitution of India as well as various international instruments accentuates the importance on health by incorporating it as one of the most basic human right. Paramountcy has been given to health in the Constitution by implicitly reading into Article 21.7 In Consumer Education and Research Centre v UOI,8 ‘right to health’ has been declared as an intrinsic component of a meaningful life.
E-pharmacy strikes at the very core of “Right to health” because of the ill-effects it bears on the health of a person by being un-regulated. The Supreme Court State of Punjab v Ram Lubhaya Bagga,9 stated that for every right vested in one person there exists a duty in another person, be it the government, the employer or others. In pursuance of this jural co-relation, the state is duty bound to secure the health of its citizen keeping in view Articles 38, 39(e), 41, 42 & 47.
Threats posed by unregulated online pharmacies booms large and compromises with the promise of ‘Right to health’ as:
i. ‘Right to health’ includes in its ambit ‘accessibility to the health care services’, this implies that such accessibility must be of approved drugs only. Hence, availability of innumerable medicinal drugs via online apps exposes the people even to those which are not so approved. There is no denying that harmful and habit-forming drugs can be purchased without a second thought. This runs contrary or is inimical to the agenda of government to make the nation ‘zero tolerance’ for drug addiction.
ii. Unlicensed online pharmacies create dubiety with respect to the quality of drugs. Reliability is directly under the scanner, making such drugs questionable in context of safety and health of people.
The Delhi High Court recently on October 5, 2018, issued a notice in the petition seeking ban on online pharmacies and stated,
[T]hus, the citizens “right to health” under Article 21 of the Constitution of India cannot be compromised by the Respondents Nos. 1 to 4 by not taking action against the indiscriminate availability and usage of drugs and prescription medicines. Further, it is submitted that the State has a duty under Article 47 of the Constitution of India to ensure that the citizens do not get addicted to drugs and do not damage their health by using prescription drugs without any control.10
Hence, the state is bound not to sit as a mere mute-spectator and allow ‘e-pharmacies’ to play with the health of its citizen. This urges the State to adopt pre-cautionary measures to guard against the same since e-pharmacy market in India is at inceptive stage.
III. A glimpse into international e-pharmacy governance
As the digital world is omnipotent, same is with the online pharmacies surfacing via digital arena, thus, indicating its presence in every part of the world. It is pertinent to note that the activity of selling medicines online itself is not illegal, but selling them without meeting the mandatory measures providing safeguards regarding quality, reliability and licensed selling of medicines, without an iota of doubt, is illegal.
The first ever warning for illegal online pharmacies was issued by “World Health Organisation” (WHO) in 1997. It called upon the nation-states to rigidify the control on online pharmacies, selling medical products. It also affirmed that such internet sale made by flouting the national regulatory bodies measures or rules results in endangering public health and risking patient’s health.11
The key international player calling the moves concerning the illegal online pharmacies is the “International Narcotics Control Board” (INCB) which has come up with the expression ‘Internet based drug trafficking’ for ‘illicit sale of drugs online’. INCB owes its existence to the “Single Convention on the Narcotics Drugs, 1961”12 (Drugs Convention). It is concerned with the a two-fold objective, firstly, of ensuring compliance with the Drugs Convention and secondly, supervising the international drugs control system.
Apart from the above-mentioned international functionaries, the “Commission on Narcotic Drugs in its Resolution 43/8” in 2000 acknowledged the booming transactions of illegal sale of ‘controlled drugs’ using World Wide Web.13 Henceforth, it called upon the member states to ‘cooperate with each other and exchange data respecting sales taking place through WWW’; and ‘increasing level of control & monitoring the websites involved in such sale’. Later, in 2004, the “Economic and Social Council” (ECOSOC) came up with Resolution 2004/42,14 titled, “Sale of internationally controlled licit drugs to individuals via the internet”, pressing upon the dire need to prohibit the internationally controlled drugs via internet, and encouraging the states to come up with regulations and sanctions with respect to same.
In 2009, the INCB came up with Guidelines, titled, “Guidelines for Governments on preventing the illegal sale of Internationally controlled substances through the Internet” to provide guidance to the nation-states in devising rules for controlling illegal sale of medicines through the online medium. The 2009 Guidelines are the only international instrument that is solely dedicated to this cause and discuss the matter in detail. Hence, it becomes imperative to analyse the guidelines which are divided into three parts, in Table 1 below.
| TABLE 1 | ||
|---|---|---|
| PART I: “Legislative & Regulatory Measures” | PART 2: “General Measures” | PART III: “National & International Measures” |
| Guideline No. 1: States to incorporate in their regulation provision endowing power to appropriate authority to take legal action against the “Internet Pharmacies”, the websites and even the internet service providers. Guideline No. 2: States to supervise the “mails” via which internationally controlled substances are shipped. Guideline No. 3: States to ensure respect for other states regulations, prohibiting shipment of “internationally controlled substances”. Guideline No. 4: States to require all the “Internet pharmacies” involved in sale of internally controlled substances to be registered and issuance of licence for the same. Guideline No. 5: States to frame “standard for good professional conduct” for online pharmacies. And, such standard must be inclusive of all the ‘legal and administrative requirements’ which ‘traditional pharmacies’ are required to meet. Guideline No. 6: States to frame standards and publish the same concerning the doctors, who offer their services to patients through online medium. Guideline No. 7: States to ensure that all the “Internet Pharmacies” involved in sale of internationally controlled substances to comply with three international drug treaties. Guideline No. 8: States, whose regulatory mechanism are not sufficient to prevent illegal sale and in issuing sanctions w.r.t internally controlled substances to adopt “corrective measures”. | Guideline No. 9: States to evaluate the adequacy of regulations regarding “reporting & inspecting systems” of illegal sale. It also encourages information exchange at both, national & international level. Guideline No. 10: States to build a mechanism for rapid data/information exchange of suspicious sales to the competent authorities. Guideline No. 11: Communicate the detection of any illegal sale and information to states involved and the INCB. Guideline No. 12: States to ensure information pertaining to national laws affecting the Internet pharmacies is given to the ‘Secretary-General’. Guideline No. 13: States to apprise the enterprises and industries involved in online transaction about the ‘illegal sale of preparations containing internationally controlled substances through internet’. Guideline No. 14: States to establish cooperative relation with all the key players involved in illegal online sale, such as industries, internet service providers, etc to aid in investigation such illegal operations. | Guideline No. 15: States to encourage “intern ministerial cooperation” with respect to control of Internet or online pharmacies and other similar websites with a view to “developing policies and conducting operational activities”. Guideline No. 16: States to establish “Cyberpatrol units” & to gather information on “drug trafficking through internet”. Guideline No. 17: States to strengthen the collaboration among the healthcare authorities, law agencies and postal services. Guideline No. 18: States to provide training to the recruits of private postal and courier agencies to identify any suspicious and illegal shipments. Guideline No. 19: States to create a ‘co-operative mechanism’ for all industries engaged in sale of ‘internationally controlled substances’. Guideline No. 20: States whose legislation permits online pharmacies to advise its healthcare and pharmaceutical authorities to to formulate a “certification programme for online pharmacies. This will enable patients to check the legitimacy of such online sites. Guideline No. 21: States to take steps to make public aware of the risks involved in purchasing internally controlled substances through unlicensed websites & to cooperate with consumer groups. Guideline No. 22: States having experience in establishing & enforcing regulatory framework this field to provide their expertise to other states. Guideline No. 23: States having experience in “identifying, investigating & prosecuting” to the illegal sale in this field to provide their expertise to other states. Guideline No. 24: States to ensure that their national authority reply positively to any request made by other states. Guideline No. 25: States to devise adequate investigating and seizure methods. |
IV. Regulatory regime in india for e-pharmacy
In India, presently there is a dearth of law concerning the sale of drugs through online portals. However, there are some legislations framed in pursuance of Article 19(g) of the “Constitution of India”, which indirectly touch upon and govern some aspects of internet drug stores (Table 2).
| TABLE 2 | ||
|---|---|---|
| Statutes | Description | |
| “Drug and Cosmetics Act, 1940” along with “Drugs and Cosmetics Rules, 1945” | This Act provides for prohibition on import15, manufacture & sale16 of any drug that is not of ‘standard quality’, or is ‘misbranded’, ‘spurious’, adulterated’’, or where ‘proprietary of medicine is not displayed appropriately’, etc. Moreover, the Central Govt. in pursuance of its power u/s 33 has barred sale of any drugs specified in Schedule H, H1 & X (known as Prescription Drugs) by unlicensed retailer and also that a licensed retailer can sale drugs only on prescription under Rules, 1945. | |
| The Drugs (Control) Act, 1950 | This Act specifically provides for the prescribed limits pertaining to maximum quantity which a dealer or producer may possess or produce; and the maximum price at which a particular drug can be sold. And, possession or sale of a drug in excess than prescribed is a punishable offence u/s 13. | |
| Information Technology Act, 2000 | By taking aid of Section 81 of the Act, which declares, “…provision of this act shall have effect notwithstanding anything inconsistent contained in any other law...”, one come to the conclusion that sale or offer for sale through online medium will be governed IT Act, 2000. However, the Act is silent with respect to existence and governance of online or internet pharmacies. It has to be read along with above mentioned statutes. Further, ambiguity about the usage of IT Act for online pharmacies still remains. | |
| Pharmacy Practice Regulation, 2015 | This regulation defines ‘prescription’ in such a manner under regulation 2(j) as to include even a ‘electronic direction from a Registered Medical Practitioner’ However, whether such electronic prescription or their scanned copy will be acceptable for buying medicines online or not is doubtful. | |
Despite the existence of all the above statutes, rules and regulation, there is no acceptable definition available of e-pharmacy and no rules with respect to it. This situation continued to persist till the announcement of Pharmacy Regulation, 2015.
And, this vacuum created by absence of specific legislation also had a negative impact on other laws existing for the time being in force, such as:
- “Drugs & Magic Remedies (Objectionable Advertisement) Act, 1954”: This act list down all the ailments for which false or misleading advertisements is prohibited. However, online portals can easily flout this rule because of absence of specific bar.
- “Indian Medical Council Act, 1956” & “Code of Ethics Regulation, 2002”: MCI code, 2002 in its Regulation 5.3 provides working and cooperation of doctors and pharmacists, hand in hand. However, with emergence of e-pharmacy this relationship will be lost. Moreover, Regulation 6.4 prohibits giving o rebates or commission. But, e-pharmacies are engaging doctors to provide prescription and advising such online portals for purchasing.
- “Narcotics Drugs & Psychotropic Substances Act, 1985”: It monitors the sale of narcotic drugs and other substances. But, not their sale through online medium. This paves way for unregulated & uncontrolled sale of such drugs.
Also, information available to e-pharmacies about the consumers is not protected. This is a big loophole in a patients’ right to privacy.
On 30th December 2015, the “Drugs Controller General of India” (DGCI) placed a temporary ban on the online sale of medicines in contravention with 1940 act until the Sub-committee so constituted do not gives recommendation on this matter.17 Irrespective of the continuance of this ban, the online pharmacies continued to flourish and no legal actions were also taken against them.
However, recently this year on 28th August, “Ministry of Health & Family welfare” came up with the draft rules on “Sale of Drugs by E-pharmacy” (Draft of E-Pharmacy Rules, 2018) to be incorporated as Part VIB in “Drugs and Cosmetics Rules, 1945”. If this draft rule is accepted, then this will be foremost step by the legislation in regulating online pharmacies.
The Draft Rules, 2018 draws a fine line between the terms “e-pharmacy” & “e-pharmacy portals”. The former is defined as “business of distribution or sale, stock, exhibit or offer for sale of drugs through web portal or any other electronic mode”18, whereas the latter as “a web or electronic portal or any other electronic mode established and maintained by the e-pharmacy registration holder to conduct business of e-pharmacy”19. The main provisions of the Draft of E-Pharmacy Rules, 2018 are discussed below:
| Rule 67J: Registration of e-pharmacy | This rule stipulates a mandatory requirement of registration for the person who decides to ‘sell’, ‘offer for sale’, ‘exhibit’, etc through e-pharmacy portals. Further, such e-pharmacy registration holder must address the grievances of buyers by establishing a customer support and redressal mechanism. |
|---|---|
| Rule 67K: Disclosure of Information generated through e-pharmacy portals | E-pharmacy registration holder must: Not disclose information received by way of ‘prescription’ or ‘in any other manner’ to any other person Provide such information to Central or State Government for public health purpose, if needed. |
| Rule 67L (Application for registration); 67M (Conditions for grant of registration) & Rule 67N (Grant of Registration) | Person intending to conduct business of e-pharmacy must apply for grant of registration to ‘Central Licensing Authority’ (CLA) in ‘Form 18AA’ by submitting fees of Rupees 50,000 along with information required. Further, Rule 67M stipulates the conditions to met for grant of registration such as, compliance with IT Act & Rules; maintaining confidentiality, maintenance of memos, etc. Lastly, on fulfilment of above requirements set out, the CLA may grant registration |
| Rule 67O: Periodic inspection of e-pharmacies | Inspection of the premises from where e-pharmacy business is conducted is to be done every two years by officers, with or without experts authorised by CLA. |
| Rules 67P: Procedure for distribution or sale, of drugs through e-Pharmacy | On receipt of prescription through e-pharmacy portals, the registered pharmacy after verification on behalf of e-pharmacy registration holder shall arrange for dispensation of drugs OR the registered pharmacy holder shall dispense and supply drugs from any wholesale or retail licensed premises under 1940 act. |
| Rule 67Q (Validity of registration of e-pharmacy) & Rule 67R (Renewal of Registration of e-pharmacy | Registration issued must remain valid for a period of three years from the date of issue. And, Rule 67R provides for renewal of registration in Form 21AA. And, it will expire if the e-pharmacy registration holder fails to renew within a period of six months from period of expiry. |
| Rule 67S: Prohibition of advertisements of drugs through e-pharmacy | It prohibits e-pharmacy from advertising any drug through radio or television or internet or print or any other medium. |
| Rule 67T: Suspension or cancellation of e-pharmacy | If e-pharmacy registration holder contravenes with D&C Act, 1940 or this Part VIB, then CLA may after giving opportunity to hear, pass an order of suspension or cancellation. And, where two or more states have cancelled registration then registration by CLA shall be deemed to be cancelled. This rule also provides for appeal to Central Govt within 45 days of receipt of order copy. |
| Rule 67U: Complaint Redressal Mechanism | Step 1: A consumer may file a complaint to States Drug Controller in case of sale of misbranded or adulterated or spurious or not of standard of quality through e-pharmacy. Step 2: States Drug Controller shall take action according to D&C Act 1940 and Rules, 1945. However, this does not bar any action under the Consumer Protection Act, 1986. |
| Rule 67V (Monitoring of e-Pharmacy) & Rule 67W (Mode of payment of fee) | This rule imposes duty on e-pharmacy registration holder to maintain and update information regarding “drugs availability, types of drugs offered for sale, details of registered medical pharmacists, and any other requirement under D&C Act, 1940” And, CLA and the ‘State Licensing Authority’ (SLA) shall monitor such information periodically. Lastly, Rule 67W provides mode by which payment of fee can be made. |
V. Conclusion
“Vaidyaraja namasthubhyam, Yamaraja sahodara
Yamasthu harathi pranan, vaidya pranan Dhanani cha”
The above-mentioned stanza means, ‘I salute the physician, who is brother of Yamraja (God of death). Yama takes away the pranan (lives), but physician takes away the pranan as well as the money’.20 This aptly showcases the situation prevailing in India, where money is given more importance than the health of an individual. Hence. ignoring the “Right to health” and the growing illegal sale of drugs online, India has certainly supported the unregulated use of online pharmacies. Though, Draft of E-Pharmacy Rules, 2018 is a step forward but whether it is sufficient still remains a question.
Hence, the authors suggest:
1. The legislators must work towards filling the gap which exists between the present legal regime and the international standards set by various resolutions and guidelines. Primarily, Guidelines of 2009 which provides detailed regulatory framework regarding online pharmacies. Adoption of this non-binding instrument will definitely make the present regime more robust.
2. Safeguards pertaining to ‘prescription’ are missing in Draft Rules of 2018. Hence, incorporation of a mechanism which will ensure “integrity & legitimacy" of such prescriptions is must.
3. Also, development of a system for shipping of controlled drugs provided in various legislation safely and securely.
4. For easy identification by consumer of safe e-pharmacies, there is a need to build an accreditation sign or seal. This is a preventive measure which will reduce the risks involved on the part of the buyers.
5. Lastly, working of Drugs Act, 1950 with the “e-Pharmacy Rules, 2018” must be ensured. As, online portals can easily manipulate the permissible quantity that can be sold and also the maximum price.
The above-mentioned suggestions can be a way forward in providing potent governance of e-pharmacies.
*****
Footnotes
1. Author is an Advocate in India.
2. ANI, ‘Number of Online Users to surpass 120 million in 2018’ The Economics Times (India, 24 June 2018) <https://economictimes.indiatimes.com/industry/services/retail/number-of-online-shoppers-to-surpass-120-million-in-2018/articleshow/64718407.cms> accessed 28 October 2018. ↩
3. Statistia, ‘Global Online Pharmacy market size in 2014 and a forecast for 2023’ (The Statistics Portal) <https://www.statista.com/statistics/819754/global-e-pharmacy-drug-market-size/> accessed 26 October 2018. ↩
4. Chetna Desai, ‘Online Pharmacies: A boon or bane?’, 2016 (Nov-Dec) Indian Journal of Pharmacology <https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5155458/> accessed 27 October 2018. ↩
5. Wikipedia, ‘Online Pharmacy’ <https://en.wikipedia.org/wiki/Online_pharmacy> accessed 22 October 2018. ↩
6. Constitution of the WHO, Preamble. ↩
7. CESC Ltd. v Subhash Chandra Bose AIR 1992 SC 573. ↩
10. Apoorva Mandhani, ‘Delhi HC issues notice on Plea for closure of Online Pharmacies’ (Live Law, 6 October 2018) https://www.livelaw.in/delhi-hc-issues-notice-on-plea-for-closure-of-online-pharmacies/ accessed 25 October 2018. ↩
11. Judy Siegel-Itzkovich, ‘WHO calls for tighter controls on Internet’ (1997) 314 British Medical Journal. ↩
12. U.N.T.S. vol. 520, No. 7515. ↩
13. CND Res. 43/8, U.N.T.S. vol. 1019, No. 14956. ↩
14. ECOSOC Res. 2004/42 on sale of internationally controlled licit drugs to individuals via the internet (21 July 2004). ↩
15. Drugs and Cosmetics Act, 1945, s 10 (Drugs Act 1945). ↩
17. Office of Drugs Controller General (India), ‘Sale of Drugs over internet contravening the provisions of Drugs and Cosmetics Rules, 1945’ N0. 7-5/2015/Misc/(e-Governance)/091 <http://www.cdsco.nic.in/writereaddata/O nline-Sale-dec-2015.pdf.> accessed 29 October 2018. ↩
18. Ministry of Health and Family Welfare, Draft of Rules on Sale of Drugs by E-Pharmacy, Notification dtd. 28 August 2018, r.67-I (a) (Draft of E-Pharmacy Rules, 2018). ↩
20. Dr. Umadethan, ‘Ethics in Medical Practice’ (Live Law, 10 September 2014) < https://www.livelaw.in/ethics-medical-practice/> accessed on 2 November 2018. ↩
- ANI, ‘Number of Online Users to surpass 120 million in 2018’ The Economics Times (India, 24 June 2018) <https://economictimes.indiatimes.com/industry/services/retail/number-of-online-shoppers-to-surpass-120-million-in-2018/articleshow/64718407.cms> accessed 28 October 2018.
- Statistia, ‘Global Online Pharmacy market size in 2014 and a forecast for 2023’ (The Statistics Portal) <https://www.statista.com/statistics/819754/global-e-pharmacy-drug-market-size/> accessed 26 October 2018.
- Chetna Desai, ‘Online Pharmacies: A boon or bane ? ’, 2016 (Nov-Dec) Indian Journal of Pharmacology <https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5155458/> accessed 27 October 2018.
- Wikipedia, ‘Online Pharmacy’ <https://en.wikipedia.org/wiki/Online_pharmacy> accessed 22 October 2018.
- Constitution of the WHO, Preamble.
- CESC Ltd. v Subhash Chandra Bose AIR 1992 SC 573.
- Apoorva Mandhani, ‘Delhi HC issues notice on Plea for closure of Online Pharmacies’ (Live Law, 6 October 2018) https://www.livelaw.in/delhi-hc-issues-notice-on-plea-for-closure-of-online-pharmacies/ accessed 25 October 2018.
- Judy Siegel-Itzkovich, ‘WHO calls for tighter controls on Internet’ (1997) 314 British Medical Journal.
- U.N.T.S. vol. 520, No. 7515.
- CND Res. 43/8, U.N.T.S. vol. 1019, No. 14956.
- ECOSOC Res. 2004/42 on sale of internationally controlled licit drugs to individuals via the internet (21 July 2004).
- Drugs and Cosmetics Act, 1945, s 10 (Drugs Act 1945).
- Office of Drugs Controller General (India), ‘Sale of Drugs over internet contravening the provisions of Drugs and Cosmetics Rules, 1945’ N0. 7-5/2015/Misc/(e-Governance)/091 <http://www.cdsco.nic.in/writereaddata/O nline-Sale-dec-2015.pdf.> accessed 29 October 2018.
- Ministry of Health and Family Welfare, Draft of Rules on Sale of Drugs by E-Pharmacy, Notification dtd. 28 August 2018, r.67-I (a) (Draft of E-Pharmacy Rules, 2018).
- Dr. Umadethan, ‘Ethics in Medical Practice’ (Live Law, 10 September 2014) < https://www.livelaw.in/ethics-medical-practice/> accessed on 2 November 2018.