E-pharmacies in India
An E pharmacy is an internet‐based vendor that sells medicines and it includes both legitimate and illegitimate pharmacies.
It is also referred as Online Pharmacy, Internet Pharmacy, Web Pharmacy or Cyber Pharmacy. Independent Internet‐only sites, online branches of “brick‐and‐mortar” pharmacies, and sites representing partnership among pharmacies fall under the purview on “online pharmacies.
Contemporary times are witnessing a surge in E‐commerce, including online shopping, and this includes the sale of prescription and non-prescription medicines as well.
The concept of online pharmacies and online sale of medicines has been in vogue worldwide for more than two decades.
An estimated 3000 online pharmacies were operating globally in the year 2008, the numbers of which would have risen as of today.
Models of e-pharmacy – There are two models which operate in this category:
• The market place model, where a technology company (e.g.: google, yahoo) connects neighbourhood licensed pharmacies to the end user.
• The inventory-based model, where e-pharmacy is the online service of an offline licensed pharmacy.
Advantages and Disadvantages: E-pharmacies offer the following advantages:
- Access to medicines for the disabled or housebound.
- Accessibility to people with limited mobility and people in remote areas.
- Convenience in term of access in rural/urban areas 24 hours a day.
- Relative privacy.
- Exposure to information.
- Option of comparison shopping.
- Increased consumer information exchange.
- Tracking of data.
- Promotion of national development and digital India.
- Lack of trilateral interaction between physician, pharmacists and patients.
- Difficult to determine whether a website is legitimate or not and hence difficult to determine whether medicines purchased online are counterfeit, unapproved, or illegal.
- Misdiagnosis and inappropriate use of medicines. These disadvantages and dangers are further exacerbated in the case of unlicensed and illegally operated online pharmacies.
- No assurance of temperature control either at their storage points or during transport.
- Chances of drug resistance, drug abuse, drug misuse, misdiagnosis, self-medication, inappropriate quality of drugs.
- Legitimate sites have appropriate technology to ensure security although the use of “cookies” to collect information about visitors and lack of secure web technology are inherent risks to anonymity.
- Medicines may be shipped across the international borders without any prescription and approval from the concerned authorities.
India is one of the fastest growing Internet markets in the world.
The number of Internet users in India rose from approximately 300 million in 2014 to around 481 million in 2017.
Indian consumers have begun using the e-pharmacy online services in the recent times. Until this year, laws for e‐commerce were ill‐defined and subject to varied interpretations.
The Maharashtra FDA in May 2015 filed an FIR (First Information Report) against the online seller ‘Snapdeal’ for selling prescription drugs on the internet along with over-the-counter (OTC) drugs.
Similar raids and FIRs were filed against chemists in Delhi and Gujarat. There was no issue regarding online sale of non-prescription drugs. Complaints and issues were with respect to the sale of prescription drugs only.
The Maharashtra FDA took the stand that online pharmacies can sell only OTC and not prescription drugs until the policy on e- pharmacies are framed.
In November 2016, the major online pharmacies formally united and formed an association Indian Internet Pharmacy Association (IIPA) and published ‘self-regulation code of conduct for e-pharmacy sector.
The Bombay High Court in October 2015, in a public interest litigation (PIL) declared that the online sales of medicines included in Schedule H of the Drug Rules without prescription and proper cash memo are illegal and directed the state government to take appropriate steps to prevent such practices.
In July 2016, the Government of India gave its support to online pharmacies and Central Drugs Standard Control Organisation (CDSCO) issued directions to all State regulators stating that there are no objections to online pharmacies as long as there is no violation of existing the laws.
In August 2018, the Ministry of Health and Family Welfare came out with a notification on the sale of drugs by e-pharmacies which legalised the e-pharmacies in the country.
Now the Rule defines an e- pharmacy as a business of distribution or sell, stock, exhibit or offer for sale of drugs through web portal or any other electronic media.
This definition makes it clear that e-pharmacy need not be ‘bricks and mortar’ (B&M) type of physical pharmacies that deal with patients/ customers face-to-face.
No person can distribute or sale drugs and medicines unless registered.
The recent amended version of Drugs and Cosmetics Act defines a prescription as an instruction from a Registered Medical Practitioner to a Pharmacist, written by hand or in electronic mode to duly signed dispense a drug to a patient. Now the doctors can write legally valid electronic prescriptions in all electronic modes, specifying the name and quantity of the drug and the details of the patient.
Various laws such as the Information Technology Act, 2000; the Drug and Cosmetics Act, 1940; Drugs and Cosmetic Rules, 1945; Pharmacy Act, 1948; and the Indian Medical Act, 1956, govern the online pharmacies in India.
As per the Indian laws,
- medicines can be sold only by a registered pharmacy that has a retail license and a registered pharmacist on payroll.
- A prescription for medicines ordered is mandatory, except for sale of over‐the‐counter products.
- It is imperative to maintain customer records including name of the patient, doctor, and address for every Schedule H and Schedule X medicines sold by the pharmacy.
- Selling medicines to minors (under age 18), selling banned drugs, and selling medicines at a cost higher than the maximum retail price are prohibited.
- Additional requirements related to privacy, diligence to cyber laws, data protection, and internet advertising are to be complied with by these pharmacies.
E-pharmacies are required to register with the Central Licensing Authority (CDSCO) in India through online portal along with the required fee (it is originally fixed as Rs. 50,000).
The registration issued to the e-pharmacy in Form 21AA shall remain valid for three years and the premises of the e-pharmacy centre will be inspected by a team of officers authorised by the Central Licensing Authority every two years.
The e-pharmacies can sell medicines only with the support of cash bill or credit memo generated through e-pharmacy portal. These bills or memos shall be maintained by the e-pharmacy registration holder as record and shall contain:
1. Name, address and sale licence number of the licensee uploaded in the e-pharmacy portal.
2. Number and date of the bill or memo.
3. Name of the drug, quantity, batch number, expiry and manufacturer of medicines dispensed.
4. Name and address of thee-pharmacy registration holder.
E-pharmacies shall not distribute or dispense medicines
- covered under the categories of narcotic and psychotropic as referred in the Narcotic and Psychotropic Substances (NDPS) Act 1985, tranquilizers and Schedule X drugs.
Adopting a futuristic approach:
- Consumer awareness is the key to curb such fraudulent practices; consumers need to be educated about the need to verify the authenticity of the service provider as well as the product and to avoid sites that sell drugs without a legal prescription.
- If the Aadhaar number of the patient, doctor and the pharmacist are linked with the e-pharmacy platform, the functioning of e-pharmacies can be made more perfect.
- If all professional Councils like Pharmacy Council initiate process of linking Aadhaar with the registration, certain unethical practices can be stopped to a certain extent.