REGULATING ONLINE SALE OF MEDICINES BY - ANU MARIA

REGULATING ONLINE SALE OF MEDICINES
AUTHORED BY - ANU MARIA
 
 
Abstract
By making pharmaceuticals more accessible and convenient for customers, the swift growth of e-pharmacies has completely transformed the pharmaceutical sector. Significant ethical and legal issues have been brought about by this change, nevertheless, including worries about patient safety, hazards to data privacy, and the possibility of abuse of online medication sales. This paper looks at India's internet pharmacy laws, pointing out areas where they are not strictly enforced. It also looks at the risks associated with the selling of illegal and counterfeit drugs, the effect of uncontrolled e-pharmacies on patient confidentiality, and unlawful data collecting. The study highlights the need for strong regulatory frameworks to guarantee adherence and protect the public's health.
 
Keywords: E-Pharmacy, Data Privacy, Patient Safety, Online Drug Sales, Regulatory Framework, Digital Personal Data Protection Act.
 
Introduction
The advantages of these online pharmacies are followed by a growing concern among clients about their safety. In particular, the most common issues raised by these online pharmacies are the quality of the drugs they provide, inconsistent dispensing, and lack of proper regulatory checks. While this trend has only recently gained popularity in India, it is very much in vogue in Western nations when properly regulated.
 
Statement of Problem
It is contended that the rise of E-Pharmacies though increasing the convenience and accessibility to consumers has raised ethical, regulatory Issues of breach of information such as patient safety, privacy and potential misuse of online drug sales.
 
Issues
  1. How has the increasing number of e-pharmacies raised ethical and regulatory concerns regarding patient safety, privacy, and the potential misuse of online drug sales?
  2. Whether illegal e-Pharmacies create their own health data on their portal violating the Right to privacy of health care records?
 
Research Objective
  1. To analyse and evaluate the ethical and regulatory issues with the increasing sales of medicines online
  2. To analyze whether illegal e-pharmacies create their own health data on their portals, violating the right to privacy of healthcare records.
 
Issue 1: Whether the increasing number of E-Pharmacies have raised Ethical and Regulatory concerns regarding patient safety, privacy and the potential misuse of online drug sales?
 
Firstly Issue No.1 should be addressed by breaking down into sub-issues of whether there has been an increase of online sale of medicines and in case the first question is affirmative then the second sub question will address whether the registration of E-pharmacies have raised the concerns regarding patient safety of privacy breaches and potential misuse of online drug sales.
 
India’s Pharmaceutical Industry is valued at USD 50 Billion with domestic consumption valued at USD 23.5 Billion and export valued at USD 26.5 Billion for the financial year 2023-24.[1] Additionally world’s third largest pharmaceutical industry by volume and 14th in terms of value of production.[2] The driving factors for E-Pharmacy has the foundation being internet penetration with Digital India supported by the Government. The changing lifestyle and disease progression and the booming of the Indian Economy with the increase in domestic demand and finally the Covid pandemic outbreak which revolutionized online workforce and home delivery.
 
A web based pharmacy is an online system that provides a platform for customers to purchase medicinal drugs and E-services online allowing the customer to receive medicines/services in the comfort of their homes within a short time.[3] The Government of India and the Ministry of Health and Family Welfare with promoting Digital India accessing Health care facilities have implemented the national health portal and schemes for providing medicines and treatment at subsidised rates. At a time when the world was put on hold and no human contact was prohibited, the role of online pharmacy developed through customised healthcare solutions with personalised health plans, telemedicine, and testing of blood samples. It has also enabled Doctors to send the prescription directly to the pharmacy electronically reducing errors and waiting periods. The Supply chain management in the pharma industry have also picked pace ensuring timely delivery of medicines. The online pharma Industry is not just limited to supply of medicines but also as an ancillary services of medication therapy management, patient counselling and prescription verification. There is continuous professional development offering ongoing education and training for pharmacy professionals to stay updated with the latest knowledge and skills. The online platform also facilitates knowledge sharing and networking among professionals globally. In earlier times, there existed only a direct link between patients/customers and the doctor who prescribed the medicine. Whereas now, the pharmaceutical industry has transitioned from brick and mortar to e-commerce platforms with regulatory bodies to ensure compliance. There is increased convenience with improved accessibility of medicines and medical services to customers.
 
While there is an increase in online sales of medicines and medical health services, in certain applications developed by pharma companies require the registration of the customer which includes the name, age, gender, pincode for home delivery and the purusance of medicines at discounted rates when registered. As soon as the registration begins, for ordering the medicines, some essential information such as the prescription is required. The feeding of prescription stores the health information of the online customer. While internet usage with a positive approach could be efficiently tracked with details of the medicines such as the batch number, the dispensing pharmacy, prescribing doctor and the data stored in these applications could be analysed for planning health care policies. The online sale of medicines without a regulatory framework risks the interstate sale of drugs, patient identity, opposition from offline medical companies. Disease and treatment are the private information of the patients, which cannot be made available for data mining and for commercial use by on-line pharmacists.[4] The Potential concerns of online pharmacy includes the rise of fake e pharmacies, sale of sensitive drugs, addressing medication errors, counterfeit medicines. Additionally online pharmacies are accused of predatory pricing.
           
The Drugs and Cosmetics Act, 1940 read with Drugs and Cosmetics Rules 1945 and the Pharmacy Act 1948 governs the manufacture, sale and distribution of Drugs and Cosmetics in India. While the existing Statue do not cater for regulating online sale of medicines, the Ministry of Health and Family welfare (Department of Health and Family Welfare) through a notification date 28th August 2018, the Central Government proposing to amend the Drugs and Cosmetics Act 1940 vide powers conferred by Section 12[5] and Section 33 of the D & G[6] published draft rules inviting public objections and suggestions. The draft rules are still yet to be notified by the Government.
 
One of the notable cases on sale of medicines online is the The Tamil Nadu Chemists and Druggists Association v Union of India[7]. The Writ Petition was filed praying for issuance of Mandamus directing the respondents (The State of Tamil Nadu,Netmeds Market Place Ltd, Digital Health Platforms, 91 Streets Media Technologies, Medlife International Pvt, M/s. Practo Technologies Pvt. Ltd, IMG Technologies Pvt. Ltd,M/s. TNMEDS, The Tamil Nadu Marunthalunar Sangam, Consumer Online Foundation) to block their website link catering to online sale of medicines prescribed under H, H1 and Schedule X which are in violation of Rules 65[8] and 97[9] of the Drugs and Cosmetics Rules 1945. Schedule H medicines are prescription only drugs and Schedule H1 drugs also require prescription and their sales require maintaining a prescription record for three years. Schedule X medicines are highly regulated psychotropic and narcotic drugs with high potential of abuse and addiction. Their storage and sale require dual lock storage and special licensing requirements.The contentions raised by the Petitioners are such that the Central Government has not passed the necessary rules  and regulations for online/Internet sale of drugs. When the sold drugs have side-effects, there are provisions under the D & G Act for recalling drugs and this is only possible when the pharmacists are aware of the movement of the drugs. In the case of online sales, this includes storing of the medicines sold online which are inclusive of the information related to the disease and the treatment availed by the customer risking the aspect of data privacy concerns. Whereas the respondents contended that the central Government did not restrict the online trading of medicines and as such the respondents would contend that only if the rules are notified by the Central government the same could be complied.
 
The important analysis raised are the benefits and advantages of online trading of medicines and also risks associated with online sales. While the prescription based drugs were sold based on online questionnaire methods instead of a valid prescription the same may result in side effects and the patient may receive counterfeit products which are sub-standard or super-potent or adulterated.  Another important point raised was the misuse of medical, financial and electronic information of patients.
 
Issue No.2: Whether illegal e-Pharmacies create their own health data on their portal violating the Right to privacy of health care records?
Herein Issue No.2 needs to be broken into sub topics such as Illegal e-pharmacies operating without compliance to data protection laws which leads to unauthorized collection, storage, and processing of personal health information leading to threats to patient confidentiality and privacy breaches violating the health data policy under national health resource mission. Additionally identifying the breaches and ensuring for a stronger enforcement mechanisms and regulatory action.
 
To answer the preliminary aspect of Issue No.2, we need to understand what the regulatory framework for online pharmacies is. The primary legislation are the Drugs and Cosmetics Act 1940 and the Drugs and Cosmetics Rules 1945 regulating the manufacture, sale and distribution of drugs and cosmetics. The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, information Technology provisions governing electronic transaction, cyber security and data protection. There is also the Draft E-Pharmacy Rules 2018 yet to be notified by the Central Government. The rules mandate the e-pharmacies to register having a physical pharmacy. Rule 67-I-a defines “e-pharmacy” as business of distribution or sale, stock, exhibit or offer for sale of drugs through web portal or any other electronic mode.[10] Under the draft rules, the definition of Prescription[11] also includes the instruction form from a registered medical practitioner through an electronic mode as well.
The main theme of the article requiring for the registration of e-pharmacy is discussed under Rule 67L[12] wherein the person intending to conduct the business of e-pharmacy shall apply for the grant of registration to the Central Licensing authority in Form 18AA through the Govt. Portal. Additionally the application shall be annexed with information[13] furnished with a notarised affidavit from the applicant with a fee of fifty thousand rupees and the information and documents as specified in Form 18AA.
 
There is a clear restriction[14] on e-pharmacies for not to carry out e-pharmacy with respect to the drugs covered under the categories of the Narcotic and Psychotropic Statue 1985, tranquilizers and the drugs specified in Schedule X of Drugs and Cosmetics Rules 1945. Other provisions relating to e-pharmacies are as follows:
67M. Conditions of registration of e-pharmacy
67N. Grant of registration of e-pharmacy.
67-O. Periodic Inspection of e-pharmacy
67P. Procedure for distribution or sale, of drugs through e-Pharmacy
67Q. Validity of registration of e-pharmacy
67R. Renewal of Registration of e-pharmacy
67S. Prohibition of advertisement of drugs through e-pharmacy
67T. Suspension or cancellation of registration
67U. Complaint Redressal mechanism
67V. Monitoring of e-pharmacy
67W. Mode of payment of fee
The second sub question relates to protecting the data collected by e-pharmacies. Cyber data attacks have been reported frequently [15]. The Digital Personal Data Protection Act, 2023 aims to protect the individual privacy and especially within the healthcare sector which focuses on the management of confidentiality of patient data. The Act also mandates the health care providers to obtain explicit consent before collecting, processing or sharing any personal health information of the consumer. The Act focusing on the health care sector aims to foster increased patient trust and confidence with improved data security and privacy. The Act also mentions the transfer of data across borders for opinions and specialised treatments which requires enhanced compliance requirements. The second sub question focuses on the data collected by pharmaceutical applications on online platforms at the risk of sensitive health data being leaked or misused. An important element to be identified is that the health data is owned by the patient while the actual records are owned by the care providers who act as custodians of the collected data. The health data includes the illness the patient is suffering from, the physician’s observation and diagnostic tests confirming the illness.
 
Conclusion
Online pharmacies have made it easy to get medicine for people, and particularly in poor communities. But it has also caused some valid problems regarding patient safety, data protection, and drug control. Ensuring stronger regulation, proper licensing, and compliance measures are essential to minimize such risks and render the online pharmacy sector safer.
 
Suggestions
  1. Implementation of Robust Regulatory Framework: In order to guarantee that e-pharmacies function within a well-organized legal framework, the government ought to expedite the notification of the Draft E-Pharmacy Rules, 2018.
  2. Stronger Data Protection Measures: Enforcing strict compliance with the Digital Personal Data Protection Act, 2023, to safeguard sensitive health data and prevent unauthorized access or misuse.
  3. Mandatory Licensing and Registration: Ensuring all e-pharmacies register with the Central Licensing Authority to enhance monitoring and accountability.
  4. Regular Audits and Compliance Checks: Conducting periodic inspections of online pharmacies to verify compliance with existing laws and prevent the sale of counterfeit drugs.
  5. Public Awareness and Consumer Protection: Educating consumers about the risks of unregulated e-pharmacies and encouraging them to purchase medicines from verified platforms.
  6. Stronger Enforcement Against Illegal E-Pharmacies: Implementing stricter penalties for unlicensed online pharmacies engaging in the unauthorized sale of drugs, particularly those involving Schedule H, H1, and X medicines.

[1] Ministry of Chemicals and Fertilizers (https://www.pib.gov.in/PressReleasePage.aspx?PRID=2085345)
[2] Ministry of Chemicals and Fertilizers (https://www.pib.gov.in/PressReleasePage.aspx?PRID=2085345)
[3] Desai, C. (2016). Online pharmacies: a boon or bane?. Indian Journal of Pharmacology, 48(6), 615. https://doi.org/10.4103/0253-7613.194865 
[4] Para 5, The Tamil Nadu Chemists and Druggists Association v Union of India, 2018 SCC OnLine Mad 3515 : (2019) 1 CTC 548
[5] Power of Central Government to make rules (1) The Central Government may after consultation with or on the recommendation of the Board and after previous publication by notification in the official gazette, make rules for the purpose of giving effect to the provisions of this chapter:
Provided that consultation with the Board may be dispensed with if the Central Government is of opinion that circumstances have arisen which render it necessary to make rules without such consultation, but in such a case the Board shall be consulted within six months of the making of the rules and the Central Government shall take into consideration any suggestions which the Board may make in relation to the amendment of the said rules.
[6] Drugs and Cosmetics Act 1940
[7] 2018 SCC OnLine Mad 3515 : (2019) 1 CTC 548
[8] Condition of licences, Drugs and Cosmetics Rules, 1945
[9] Labelling of medicines, Drugs and Cosmetics Rules, 1945
[11] Rule 67-I-d, Draft E-Pharmacy Rules 2018
[12] Draft E-Pharmacy Rules 2018
[13] Documents or Information to be enclosed by the applicant: (i) A copy of identity and address proof of the applicant, any one of the followings: valid passport, voter ID card, valid permanent driving license, adhaar card; (ii) Constitution details of the applicant; whether proprietorship or partnership or limited liability partnership or company; Details of mode of helpline facility for counselling the patient or his representative with respect to drug usage, its method of administration, warnings, contra-indications and any other information relating to the drugs sold through e-pharmacy; (iii) any other relevant information which may be required for the purpose of verifying the correctness of the statements made by the applicant, if any;” (Form 18AA, Draft E-Pharmacy Rules 2018)
[14] Rule 67 M (5), Draft E-Pharmacy Rules 2018