India’s nascent e-pharma sector is in a state of confusion following the different Court’s judgement on banning the sale of medicines online until the government notified regulations for the industry. It is being argued that the sale of drugs and prescription medicines online is illegal and without any mandate of law.
The Delhi high court ordered a complete ban on online pharmacies across the country with immediate effect while A division bench of the Madras High Court stayed the ban on the sale of online drugs until it delivers the final order.
E-Pharmacy and E-Prescribing
“e-pharmacy” means business of distribution or sale, stock, exhibit or offer for sale of drugs through
web portal or any other electronic mode. Drugs are different from FMCG. They are supposed to be dispensed with and used for specific ailment only as per medical advice.
E-prescribing or electronic prescribing is a technology framework that allows physicians and other medical practitioners to write and send prescriptions to a participating pharmacy electronically instead of using handwritten or faxed notes or calling in prescriptions
- E-pharmacies market is $18 billion and will grow to $55 billion by 2020.
- Industry experts estimate the market to be generating 3,000-4,000 orders on a daily basis.
Models of E-pharmacy
- Organized e-pharmacy
There are two models which operate in this category.
- The market place model, where a technology company connects neighbourhood licensed pharmacies to the end user;
- The inventory-based model, where e-pharmacy is the online service of an offline licensed pharmacy.
- Non-organized e-pharmacy
In this model prescription medicines are ordered without any validated prescription. There is no check on the genuineness of the order due to absence of qualified pharmacists. Also, improper record keeping and no audit is a major area of concern.
- Illegal international trade through e-pharmacy
In this model, drugs are shipped across the international borders without any prescription and approval from the concerned authorities.
- Currently regulatory powers have been distributed between the centre and the state governments. Central Government is responsible for licensing of drug imports and the state governments are responsible for the manufacture, sale and distribution of drugs.
- Central Government exercises regulatory control over drugs by Central Drugs Control Organisation headed by the Drugs Controller General India.
- The laws governing Pharmacies in India are
- Drugs and Cosmetics Act, 1940
- Drugs and Cosmetics Rules, 1945
- Pharmacy Act, 1948
- Indian Medical Act, 1956 and
- Code of Ethics Regulations, 2002
- When e-pharmacies regulation is concerned, there is lack of accurately and unambiguously stated laws and clear-cut guidelines to regulate, control and monitor e-pharmacies. E-pharmacies come under the purview of the Drugs and Cosmetics Act, 1940 and the Information Technology Act, 2000. But current Drugs and Cosmetics Act, 1940 doesn’t distinguish between online and offline pharmacies.
- For ensuring efficient and legitimate running of e-pharmacies, it is a need of the hour to make hassle free rules for e-pharmacies. A consultative committee on e-pharmacies was formed in 2015, which submitted its report to the DCGI in 2016
Draft Rules for E-pharmacy
The Central Government has recently notified Draft Rules for amending the Drugs and Cosmetics Rules, 1945. New provisions for “Sale of Drugs by E – pharmacy” have been proposed.
- Licensing: An e-pharmacy is not permitted without a registration certificate from a Central Licensing Authority.
- E-Pharmacy Portal: The e-pharmacy holder can receive orders only for retail sale through its portal.
- Patient data and localisation: Any information generated through the e-pharmacy portal, such as information from prescriptions, will not be disclosed to any other person for any other reason.
- Prohibitions: The e-pharmacy portal cannot carry out business or sale of drugs categorised as narcotics and psychotropics under the Narcotic Drugs and Psychotropic Substances Act, 1985 and tranquilizers and the drugs under Schedule X of Drugs and Cosmetics Rules, 1945.
- Advertising: No e-pharmacy shall advertise any drug on radio or television or internet or print or any other media for any purpose.
- Monitoring: The e-pharmacy shall maintain and update its stock information and availability, vendors and suppliers list, registered practitioner. The CLA or the State licensing authority can at any time direct an e-pharmacy to furnish a prescription on the basis of a which a drug has been dispensed.
Issues with draft rule
- Definition of prescription: A digitally signed prescription from the Doctor only or a directly communication by the Doctor to an e-pharmacy is not mandated. A scanned document is sufficient. An old prescription or a fabricated prescription could still be used to buy drugs.
- Conflict of Interest: A prescription generated by the e – phamracy, through its own panel of doctors would also be valid. Many e – pharmacies already offer the same.
- Availability of Schedule H and H 1 Drugs: Schedule H and H 1 drugs also fall under the category of the prescription drugs and are harmful if not taken as per subscription and under proper supervision.
Argument in Favour of E-Pharmacy
- Time saving and Money saving
- Enhance competition: Trade unions in India create artificial restrictions in certain regions which could be removed through competition
- Delivery of medicines at desired place at desired time possible
- Increased availability and accessibility of medicines. Convenient for some patients and old age people who can’t leave their home.
- Easy comparison of medicines in terms of cost
- Increased consumer information and information exchange
Argument against E-Pharmacy
- Supply of fake and illegal drugs
- abuse on account of fake or forged or no prescriptions;
- lack of verification of the ultimate user;
- unhealthy competition;
- abuse of critical health data generated online and
- mishandling during transport
- Indiscriminate availability and reckless usage lead to resistance to medicines
- Specific and clear-cut rules should be made for selling, prescribing, dispensing, and delivering prescription drugs through e-pharmacies.
- Make guidelines for consumers for safely accessing e-pharmacies and explains how to buy medicines safely from e-pharmacies.
- List of illegal and blacklisted e-pharmacies should be provided to help out consumers and stop them using such fake websites.
- Government should make a common logo for legally operating e-pharmacies to distinguish them from illegal one.
- It is mandatory for e-pharmacies dealing with online drugs importation and re-importation to be registered and to get licence for the same from regulating body.
- As the power of drug regulation is distributed between Central and State government, role of Central government and State government should be well defined.
- Government schemes like NRHM can aid in promoting proper procedures to acquire drugs, prevent self-medication through campaigns on television, radios and social media.
- E-pharmacy must establish its server in India as if it is outside the boundaries of India, it is difficult to control and regulate it.