Online Pharmacies: Boon or bane?

INTRODUCTION

“The pharmacist goes online.”[1]

Rapid increase in mobile users over the last decade (10 million to 354 million)[2], low cost smartphones, low mobile tariffs, search engine advertising, discounted pricing and convenience are the key contributors to the rapid expansion of e-commerce industry in India.[3] Internet is swiftly transforming our living, working and shopping ways in all sectors of the economy.[4] This increase in sale of online consumer goods comprises increase in the sale of online drugs as well. Online pharmacies as the name suggests are pharmacies that are operational over the Internet and seek to provide its customers with options to buy medicines online.[5] It provides the incentives to the people suffering from health conditions to help them manage their conditions with nominal effort. With the advent of the Internet, the gap between people living in rural areas and leading medical facilities of the country has also reduced to a bare minimal.

As beneficial as this new technology has been to its users, the risks involved in purchasing pharmaceutical products online cannot be shelved. The functionality and legality of e-Pharmacies has been questioned time and again in India nationally as well as internationally. In the year 2008, World Health Organization (WHO) issued a contemptuous disparagement to the Indian drug regulatory system by raising strong objections to India’s drug approval mechanism, which according to it are, “…approved in the country without proper documentation on pre-clinical, clinical and toxicological studies.”[6] WHO further observed that the “Indian drug regulatory authority is not independent and is functioning under pressure.”[7] Such observations have belittled the internationally established reputation of the country, which by volume is the fourth largest pharmaceutical market in the world.[8]

Online pharmacy requires a fact-based determination of all its aspects depending upon circumstances prevailing in each case. It therefore, requires adequate legislations/laws having an overarching impact upon the broadened scope of online pharmacy. With the lackluster attitude of Indian authorities towards this broadened scope it shall be hard to adopt such a mechanism.

Through this write up, we shall try to ascertain the meaning affixed to online pharmacies, its benefits and risks, current legal scenario in India and what measures it could adopt to further standardize online pharmacy.

DEFINING ONLINE PHARMACY

Explanation to Section 64 of the Drugs and Cosmetics Rules, 1945 attaches the following meaning to pharmacy:

“Section 64. Conditions to be satisfied before a license in Form [20, 20-B, 20-F, 20-G, 21 or 21-B] is granted :-

…….

xxx xxx xxx

Explanation.

For the purpose of this rule the term ‘Pharmacy’ shall be held to

mean to include every store or shop or other place : (1) where drugs are dispensed, that is, measured or weighed or made up and supplied ; or (2) where prescriptions are compounded; or (3) where drugs are prepared; or (4) which has upon it or displayed within it, or affixed to or used in connection with it, a sign bearing the word or words “Pharmacy”, “Pharmacist”, “Dispensing Chemist” or “Pharmaceutical Chemist”; or

(5) which, by sign, symbol or indication within or upon it gives the impression that the operations mentioned at (1), (2) and (3) are carried out in the premises; or (6) which is advertised in terms referred to in (4) above.”[9]

However, the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945 do not attach a meaning to online pharmacy. So far, India has not codified a legal definition to online pharmacy. Regulation 2(j) [3] of the Pharmacy Practice Regulations of 2015 declared by the Pharmacy Council of India in January 2015 define prescription as: “means a written or electronic direction from a Registered Medical Practitioner…..”.[10]

According to 21 USCS § 802 (52), the term online pharmacy has been stated to mean:

“(A) means a person, entity, or Internet site, whether in the United States or abroad, that knowingly or intentionally delivers, distributes, or dispenses, or offers or attempts to deliver, distribute, or dispense, a controlled substance by means of the Internet; and

(B) does not include--

(i) manufacturers or distributors registered under subsection (a), (b), (d), or (e) of section 303 [21 USCS § 823] who do not dispense controlled substances to an unregistered individual or entity;

(ii) nonpharmacy practitioners who are registered under section 303(f) [21 USCS § 823(f)] and whose activities are authorized by that registration;

(iii) any hospital or other medical facility that is operated by an agency of the United States (including the Armed Forces), provided such hospital or other facility is registered under section 303(f) [21 USCS § 823(f)];

(iv) a health care facility owned or operated by an Indian tribe or tribal organization, only to the extent such facility is carrying out a contract or compact under the Indian Self-Determination and Education Assistance Act [25 USCS §§ 450 et seq.];

(v) any agent or employee of any hospital or facility referred to in clause (iii) or (iv), provided such agent or employee is lawfully acting in the usual course of business or employment, and within the scope of the official duties of such agent or employee, with such hospital or facility, and, with respect to agents or employees of health care facilities specified in clause (iv), only to the extent such individuals are furnishing services pursuant to the contracts or compacts described in such clause;

(vi) mere advertisements that do not attempt to facilitate an actual transaction involving a controlled substance;

(vii) a person, entity, or Internet site that is not in the United States and does not facilitate the delivery, distribution, or dispensing of a controlled substance by means of the Internet to any person in the United States;

(viii) a pharmacy registered under section 303(f) [21 USCS § 823(f)] whose dispensing of controlled substances via the Internet consists solely of--

(I) refilling prescriptions for controlled substances in schedule III, IV, or V, as defined in paragraph (55); or

(II) filling new prescriptions for controlled substances in schedule III, IV, or V, as defined in paragraph (56); or

(ix) any other persons for whom the Attorney General and the Secretary have jointly, by regulation, found it to be consistent with effective controls against diversion and otherwise consistent with the public health and safety to exempt from the definition of an "online pharmacy.”[11]

BENEFITS OF ONLINE PHARMACY

The biggest advantage of online pharmacy is the simplicity and convenience with which wide variety of pharmacies and medicines could be accessed online. With online pharmacy, an option is given to the users to determine the caliber and legitimacy of an existing or prospective pharmacy by perusing through their reviews and user feedbacks.[12] It further makes it easier for the Senior citizens and Physically challenged to order their prescriptions online. Certain legitimate Internet pharmacies on registration of a patient (online) offer services of a pharmacist through telephone or e-mail as well, which expedites consultation and saves time and money.[13] Further, delivery times may vary but online pharmacy provides a 24 hours access to its unlimited pharmaceutical options. The customer may order any medicine at any given time of the day/night and can expect even a one-day delivery depending upon the terms and conditions in place. Privacy is also a major advantage as the identity of a user is secured. It is an added advantage to those who don’t want to disclose or discuss their medical condition. For a country like India where people still get nervous buying birth control contraceptives, online pharmacy is ideal.

RISKS INVOLVED

“Be nice, I am in charge of the happy pills.”[14]

Online Pharmacy with its convenience and simplicity also brings with it a baggage of risks that cannot be taken lightly. The very global nature, anonymity, broadened scope beyond jurisdictions and the ease of creating websites with multiple related sites and links, which the Internet is known for, creates problems for effective law implementation. If stringent legal mechanisms, law enforcement agencies, customs and national medicines regulatory authorities are not in place to keep a check on illegal activities on the Internet, it could lead to Sale of unapproved drug products, sale of products making fraudulent health claims, the importation, sale, or distribution of an adulterated or misbranded drug, the importation, sale, or distribution of an unapproved new drug, illegal promotion of a drug, the sale or dispensing of a prescription drug without a valid prescription and counterfeit drugs.[15] Further, certain websites offer online prescriptions on the basis of questionnaires filled by its users, which they claim are assessed by their consulting doctors who offers prescriptions accordingly.[16]

One can only imagine, the ramifications of such websites not being verified by the concerned Internet regulatory bodies, which could sell contaminated or wrong medications that may have potential side effects and may also give improper dosage leading to allergic reactions.[17] The anonymity of the Internet brings with itself the risk of its misuse as well. A user who trusts an online pharmacy may be compromising upon his security by providing his personal/payment details to such websites, which could lead to misuse of his personal data, card payment details and also compromise his privacy.[18]

As I have briefly deliberated above, WHO has found serious lacunae in the functioning of the drug regulatory system in India with regard to the online pharmacies.[19] Lets take a look at this lacunae and remedies that may be exercised for overcoming it.

LEGAL MECHANISMS IN FORCE IN INDIA

“Our Law currently doesn’t identify online advertisement or trade of drugs, though there are measures to check the authenticity of drug ingredients or finished formulations when they are physically transferred from one place to another.”[20]

Mr. M. Venkateswarlu, former Drug Controller General of India stated this during his tenure as the Drug Controller General of India. Sadly, approximately 10 years have passed since then and India still hasn’t been able to enact well-defined dedicated laws for online pharmacies.[21] Maharashtra FDA Commissioner, has been quoted as saying, “..there aren't enough checks and balances to ensure that the drugs sold online are not spurious.”[22] India practically operates its online pharmacy with no legitimate regulatory control. The fast and uncontrollably growing number of online pharmacies, has posed a serious challenge to the State Drug Control Authorities. In the absence of strictly dedicated laws, Indian pharmacies are relying majorly on the Information Technology Act, 2000, the Drug and Cosmetics Act, 1940, the Drugs and Cosmetics Rules, 1945 and the Pharmacy Act, 1948.

As per Section 2 (f) of the Pharmacy Act, 1948 a medical practitioner as a person holding a qualification under Section 3 of the Indian Medical Degrees Act, 1916, or specified in the Schedules to the Indian Medical Council Act, 1956, registered or eligible for registration by a State or registered or eligible for registration in the register of dentists.[23] While, a registered pharmacist has been defined as, “a person whose name is for the time being entered in the register of State in which he is for the time being residing or carrying on his profession or business of pharmacy.”[24] On perusal of the Pharmacy Act, no regulations codifying online pharmacist or pharmacy are found.

Further, Section 10 of the Drugs and Cosmetics Act, 1940 prohibits import of certain drugs or cosmetics, which are not of standard quality, misbranded, adulterated etc.[25] However, if an illegal pharmacist is selling medicines online, the Drugs and Cosmetics Act, 1940 does not enumerate how the quality or standard of such medicines shall be ensured. Problem further escalates if the medicines bought are listed under Schedule K of Rule 123 of the Drugs and Cosmetics Rules, 1945, which can be sold without prescription.[26]

In addition to above, Section 4 and 5 of the Information Technology Act, 2000 (IT Act) give legal recognition to electronic records and digital signatures.[27] But nowhere does the IT Act enumerate how the authenticity of a medical practitioner who possesses an international degree and digital signature that he can place on an electronic record i.e. medical prescription, for selling online pharmaceuticals, will be ascertained.

Therefore, Indian laws are lacking as regards to collectively governing sale and purchase of prescribed drugs and medicines online.

SO WHAT CAN BE DONE?

With the Maharasthra Food and Drug Administration (FDA) putting Snapdeal under scanner and filing an FIR against its Chief executive Kunal Bahl and the company’s directors, in connection with the sale of prescription drugs online, one this is clear that the online pharmacies websites of India are under regulatory scanner and punishments may follow soon. An effective Internet enforcement process requires establishing priorities, identifying and monitoring potentially violative websites and making appropriate referrals for criminal prosecution and/or civil enforcement actions. The following suggestions could be considered as a way to move forward:

Strengthening Global Ties and Extradition Treaties: Section 3 and Section 4 of the Indian Penal Code enumerate punishments of offences committed beyond the jurisdiction of India, but which by law may be tried within, India and also extension of Code to extra-territorial offences.[28] However, for bringing just illegal pharamcies/pharmacists to justice, India has to ensure that it spreads establishes strong connections with countries world wide through such policies and enactments that may help it in according the necessary protection to the users online. Stronger extradition treaties may help in according the necessary protection to the consumers in the country. Protection provided under IPC extends to foreign nationals (sections 3 and 4 of IPC) but India should have an extradition treaty with the said country. Establishing a contact with the health industries of other countries could enable a criminal investigation in that country itself.
New Zealand Health Ministry is considering Measures to prevent pharmaceuticals from being dispensed from their territory to overseas consumers without a prescription and necessary certification by the country itself.[29] Some countries and regions provide online verifications and certifications. For instance, EU logo for online sale of medicines, US Food and Drug Administration and US Nationals Associations of Boards of Pharmacy.[30] Such a Drug Sales Action Plan preventing the unlawful sale of drugs over the Internet to and fro could be a way to move forward. Verification shall be made mandatory for online pharmaceuticals with a legitimate seal of approval to provide the necessary assurance to the consumers that the said designated sites are offering government approved pharmaceuticals.
Awareness may also be spread through Media Campaigns, Radios Health Care Providers, and Consumer advocacy organizations, about safe ways to purchase pharmaceuticals online.
Taking preventive measures such as adherence of websites to all privacy laws and regulations in the jurisdictions where the website offers to ship drugs from and to, prior background check of the pharmacists and physicians, getting international pharmacists and pharmaceuticals approved from international Food and Drug Administration such as US (FDA).
Consumer confidence can also be gained through preparing a database distinguishing legal and illegal sites. For instance, the one developed by the United States National Association of Boards of Pharmacy (NABP) has developed the Verified Internet Pharmacy Practice Sites (VIPPS).[31]

CONCLUSION

“This is an industry that isn’t just going away, but is getting better at conducting their illicit activities and preying on the public,”[32]

With electronic commerce expanding beyond local jurisdictions onto global markets, the world should strive towards consistent principles across state, national and international borders promoting safety and increasing effectiveness of the current law regime, notwithstanding the jurisdiction in which a buyer or seller resides. However, the benefits derived from online pharmacy cannot be sidelined. Therefore, an equilibrium has to be arrived at between the legitimate electronic online pharmaceutical industry, which should be allowed to flourish and protection accorded to the consumers purchasing drugs online, which should be just as strong as the trust they put in purchasing pharmaceuticals online. A serious challenge to the Indian government but is a solution that is the most optimal.

Disclaimer: The views and opinions expressed in this article are based on extensive and thorough research. In no way does the author or the law firm claim ownership of the ideas and concepts presented in this paper. Information so provided is to be strictly considered for general reference of the subject matter, which has been adequately referenced. Specialist advice should be sought about any specific circumstances directly from the law firm.

REFERENCES

[1] Shobita Dhar, “The pharmacist goes online, 11 May 2015”, <http://timesofindia.indiatimes.com/india/The-pharmacist-goes-online/articleshow/47228104.cms > accessed 18 December 2015

[2] Neha Alawadhi, “India’s internet user base 354 million, registers 17% growth in first 6 months of 2015: IAMAI report” (economictimes.indiatimes.com, 3 September 2015) <http://articles.economictimes.indiatimes.com/2015-09-03/news/66178659_1_user-base-iamaiinternet-and-mobile-association > accessed 17 December 2015

[3] Ibid

[4] William K. Hubbard, “Testimony on Enforcing the Laws of Pharmaceutical Sales Over the Internet” (hhs.gov, 25 May, 2000) < http://www.hhs.gov/asl/testify/t000525b.html > accessed 17 December 2015

[5] Guest Post, “Legality of Selling Medicines Online in India” (blog.ipleaders.in, 30 September 2015) <http://blog.ipleaders.in/legality-of-selling-medicines-online-in-india/ > accessed 17 December 2015

[6] J. Sai Deepak, “SpicyIP Tidbits: Indian Drug Regulatory System Forced to Swallo the Bitter Pill by WHO” (spicyip.com, 28 April, 2008) < http://spicyip.com/2008/04/spicyip-tidbits-indian-drug-regulatory.html > accessed 17 December 2015

[7] Ibid

[8] Ibid

[9] Section 64 of the Drugs and Cosmetics Rules, 1945 <http://www.cdsco.nic.in/writereaddata/Drugs&CosmeticAct.pdf > accessed 17 December 2015

[10] Pharmacy Practice Regulations 2015

[11] Online Pharmacy Law & Legal Definition (definitions.uslegal.com) <http://definitions.uslegal.com/o/online-pharmacy/ > accessed 17 December 2015

[12] The Advantages of Online Pharmacies (Pharmacies.com.au) <http://www.pharmacies.com.au/articles/the-advantages-of-online-pharmacies/ > accessed 18 December 2015

[13] Harri Ovaskainen (Internet Pharmacies: advantages and risks) <http://apps.who.int/medicinedocs/en/d/Jh2989e/2.html#Jh2989e.2.1 > accessed 18 December 2015

[14] Product, < www.amazon.in > accessed 18 December 2015

[15] Id, 4

[16] Id, 12

[17] Id, 4

[18] SSFFC Medical Products – The Internet (World Health Organization) <http://www.who.int/medicines/regulation/ssffc/med_prod_internet/en/ > accessed 18 December 2015

[19] Ramesh Shankar, Mumbai (WHO finds fault with Indian Drug Regulatory System, 24 April 2008) <http://www.pharmabiz.com/article/detnews.asp?articleid=43980&sectionid> accessed 18 December 2015

[20] C.H. Unnikrishnan and Marion Arathoon, “Lax Regulation Sees India Becoming A Haven for Illegal Online Pharmacies – Livemint” (Livemint.com, 15 September 2008) < http://www.livemint.com/Home-Page/NFIWys7sX5w4TX7RzrqrKI/Lax-regulation-sees-India-becoming-a-haven-for-illegal-onlin.html > accessed 17 December 2015