Letter
E-pharmacies in India: Empowerment or an Emerging Conundrum?
Authors
Geetha Mani, Assistant Professor,
Raja Danasekaran, Assistant Professor,
Kalaivani Annadurai, Associate Professor,
Department of Community Medicine, Shri Sathya Sai Medical College and Research Institute, Kancheepuram, Tamilnadu, India
Address for Correspondence
Dr. Geetha Mani,
Assistant Professor, Department of Community Medicine,
Shri Sathya Sai Medical College and Research Institute,
Tiruporur- Guduvancherry Main Road, Ammapettai Village,
Sembakkam Post, Chengalpat Taluk,
Kancheepuram District, Tamil Nadu - 603108.
E-mail:
drgeethammc@gmail.com
Citation
Mani G, Danasekaran R, Annadurai K. E-pharmacies in India: Empowerment or an Emerging Conundrum? Online J Health Allied Scs.
2017;16(1):14. Available at URL:
http://www.ojhas.org/issue61/2017-1-14.html
Submitted: Oct 29,
2016; Sugegsted Revision: Dec 25, 2016; Revised: Dec 27, 2016; Accepted: April 1, 2017; Published: May 15, 2017 |
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E-pharmacy also known as online pharmacy, internet pharmacy, cyber-pharmacy or mail-order pharmacy is a pharmacy that operates over Internet and sells pharmaceutical preparations to customers via online ordering and mail delivery.[1] The online sale of medicines started in 1990s. With globalization of markets and improved internet connectivity, online marketing of medicines and medical products is here to stay.[1] A culture of self-diagnosis and self-prescribing has led to the emergence of thousands of unregulated online pharmacies providing unsupervised access to medical products prompting United States (US) Food and Drug Administration (FDA) to allot an entire section of its website to “Buying Medicines over Internet”.[1,2] World Health Organization addresses this issue under the purview of Substandard, spurious, falsely labelled, falsified and counterfeit (SSFFC) medical products.[2]
E-pharmacies are a convenient mode of medicine purchase for patients who are sick and unable to go to an off-line pharmacy.[3,4] Being an online system, e-pharmacies can have extended inventory by aggregating purchase and supplies, thereby helping customers avoid the difficulty of purchasing medicines from different pharmacies.[1,3,4] The advanced technology employed can be effectively used to educate consumers on safe drug practices, adverse drug reactions, drug interactions and encourage them to clarify doubts on embarrassing issues by ensuring privacy.[3,4] The effective maintenance of purchase and transaction records help in tracking sources of counterfeit medicines, accurate taxation details, ensuring transparency and authenticity. The enormous amount of data collected can be used in epidemiological research and framing effective public health policies.[3]
Despite benefits listed above, illegitimate e-commerce in the form of fake or rogue online pharmacies constitute a potential public health risk. In 2014, US Government Accountability Office estimated that there were 36000 rogue internet pharmacies which supplied drugs without prescription.4 A United Kingdom (UK) study of 113 online pharmacies found that less than one-fourth were regulated.[4] A research by National Bureau of Economic Research (NBER) identified that atleast 9% of the tested products purchased from non-certified online pharmacies were counterfeit.[3]
Unlike conventional pharmacies with controlled distribution systems e-pharmacies have difficulties in storage and transit.[4] There is possibility of sale of illegal, out-dated, unregistered, falsified, substandard medical products; improper storage at substandard temperatures; minors and children buying controlled and banned drugs from illegal or unethical pharmacies and a potential threat of misuse of personal and payment card details with compromised computer content and privacy.[2,4]
Some internet pharmacies sell medicines without prescription or prescribe medicines based on health questionnaire using their in-house physicians which might be potentially dangerous.[2,4] Lack of consumer awareness blurs distinction between wilful abuse and unknowing misuse. Unregulated use of antibiotics may aggravate antimicrobial resistance.[1,4] Restricted drugs might be bought from multiple online pharmacies using same prescription.[4]
Unregulated e-pharmacies are an issue of international concern, since despite domestic legal regulations in each country access to drugs from abroad disrupts the regulatory equilibrium achieved.[1] Doctor-patient relationship is also disrupted.[1]
Developed countries have organised verification and authentication programmes such as Verified Internet Pharmacy Practices Sites (VIPPS) and Legitscript in US, green cross logo (UK) and common logo in European Union (EU) countries.[5,6] Most developed countries have recognised organisations to govern e-pharmacies- National Association of Boards of Pharmacy and Joint Commission on Accreditation of Healthcare Organizations (US), Health on the Net Foundation (Switzerland), General Pharmaceutical Council (UK) and Pharmacy Board of Australia (Australia).[1,4,6]
Unlike developed countries, India does not have prescribed policies for regulation of online pharmacy market. The Drugs and Cosmetics (D and C) Act, 1940 and the Drugs and Cosmetics Rules 1945 have recommended guidelines on sale of Schedule H and Schedule X drugs, which can be sold only on prescription. The subsection-1 of section 42, Indian Pharmacy Act 1948, states that no person other than a registered pharmacist shall compound, prepare, mix or dispense any medicine on the prescription of a medical practitioner. Subsection-2 states the punishment for contravening subsection-1.[7]
Regulation of online pharmacies in India is complicated by variety of legal issues, namely, laws pertaining to e-commerce, laws related to pharmacies and online pharmacies, mobile health related laws, telemedicine related laws, and cyberspace related regulations.[8] India lacks laws similar to Health Insurance Portability and Accountability Act of 1996 and Health Information Technology for Economic and Clinical Health Act (HITECH Act) of US to govern medico-legal and techno-legal issues of e-health. Fool-proof data protection and privacy laws are also deficient.[8]
In India, there have been registered instances of e-pharmacy malpractices identified by Gujarat Food and Drug Control Administration (FDCA) where regulatory action was taken under provisions of D and C Act and Narcotic drugs and Psychotropic substances (NDPS) Act.[9] Maharashtra FDA identified an e-commerce site selling prescription drugs online.[9] The Telangana Drug Control Administration has identified online sale of restricted drugs of Schedule H and H1 without prescription in April 2015.[9] Since the existing D and C act does not prescribe guidelines for e-pharmacies, the Drugs Controller General of India (DCGI) is planning framework to regulate e-pharmacies and incorporate them into the existing system and has directed the state FDAs to maintain strict vigil on online sale of medicines.[9]
E-pharmacies unless perfectly regulated could be a double-edged sword. It might empower consumers and e-commerce on one-hand, while being a potential public health risk conundrum on the other. The solution is three-fold involving the primary stakeholders- the Government, online pharmacy network and consumers.
The Government should ensure strengthening of internet regulatory technologies, devise fool-proof policy framework guidelines for e-pharmacy regulation based on successful examples from other countries and adopt and conform to international guidelines and regulatory laws.[1] The D and C act, 1940 and NDPS act, 1985 should be amended to strictly regulate and prevent abuse of controlled drugs. The online-pharmacy network has an important role in maintaining the safety and standards throughout the supply chain. The maintenance of strict temperature control could be secured by use of express mail or couriers and insulated shipping containers.[1] The validity of prescriptions received should be checked by a dedicated team of registered pharmacies and the prescriptions should be stamped to prevent misuse and reuse.[9] E-pharmacies should restrict their supply to medications on chronic diseases. Consumers should be educated not to respond to spam emails, to always check for verification logo on the e-pharmacy website and confirm its authenticity, check for spelling and grammar mistakes and identify the landline addresses of the website.[2] They should also be instructed to avoid pharmacies which sell prescription-only medicines without prescription and not avail e-pharmacy services for emergency services.[2] Any doubts or incidence of adverse event related to a medical product should be reported to the National Medicines Regulatory Authority as early as possible by the consumer or the treating physician.[2]
With increasing digitalization in India, e-pharmacy has the potential to become an indispensable aspect of health care delivery in future. Hence it is of utmost importance that the Government and citizens are equipped enough to maximise the benefits without compromising quality of health care and online privacy and security.
References
- Orizio G, Merla A, Schulz PJ, Gelatti U. Quality of online pharmacies and websites selling prescription drugs: A systematic review. J Med Internet Res. 2011;13(3): e74
- World Health Organization. Essential medicines and health products. Available at http://www.who.int/medicines/regulation/ssffc/faq-ssffc_1-10/en/index4.html Accessed on January 26, 2016
- Sinha S. How e-pharmacy can empower consumers. Economics Times. May 25, 2015. Available at http://articles.economictimes.indiatimes.com/2015-05-25/news/62624766_1_registered-pharmacists-prescription-model Accessed on January 23, 2015.
- Kelly B. Online pharmacies: buyers beware. Australian Prescriber. 2015;38(6):186-7
- US Food and drug administration. The Possible dangers of buying medicines over Internet. Available at http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm048396.htm Accessed on July 21, 2016
- European commission. Public Health. Medicinal products for human use- EU-logo. EU logo for online sale of medicines. Available at http://ec.europa.eu/health/human-use/eu-logo/index_en.htm Accessed on June 26, 2016.
- Express pharma. Online pharmacies revolution in the making? Dated September 1, 2015. Available at http://www.financialexpress.com/article/pharma/management-pharma/online-pharmacies-revolution-in-the-making/128881/ Accessed on June 26, 2016.
- E-retailing laws and regulations in India. Online medicine sales in India and legal risks and regulations for e-commerce websites. Dated January 5, 2014. Available at http://ptlb.in/ecommerce/?p=179 Accessed on June 26, 2016.
- The Hindu- BusinessLine. Strong prescription needed for epharmacies. Dated June 12, 2015. Available at http://www.thehindubusinessline.com/specials/pulse/strong-prescription-needed-for-epharmacies/article7310203.ece?ref=relatedNews Accessed on June 23, 2016
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