Friday, December 14, 2018

Hon’ble Delhi High Court bans online sale of medicines across the country

On Wednesday i.e. 12.12.2018, the Hon’ble Division Bench of Chief Justice of Delhi High Court has directed the Central government and the Delhi government to restrain the online sale of medicines by e-pharmacies, as the same it is not permitted under the Drugs and Cosmetics Act, 1940 and the Pharmacy Act, 1948 in a petition filed by one Dermatologist Dr Zaheer Ahmed

The petition claimed that lakhs of medicines are being sold online through e-pharmacies, in spite of a direction of the Drug Controller General of India to the State Drug Controllers, “to put a strict vigil on online sale of medicines in violation of the Drugs and Cosmetics Act and Rules thereunder, to protect the interest of public health”, thus violating the citizens’ Right to Life guaranteed under Article 21 of the Constitution.

The petition also highlights the serious consequence that misuse or abuse of drugs can have on human health:

“A large number of children/minor or people from uneducated rural background use internet and can be victims of wrong medication while ordering medicines online which are operating without a drug license…The unregulated sale of medicines online will increase the risk of spurious, misbranded and substandard drugs being sold. Some drugs have psychotropic substances and can be easily ordered on internet and misused for criminal activities or drug abuse.”

Earlier in the month of October, 2018 the Hon’ble Madras High Court had granted an injunction restraining the sale of medicines and drugs online, on a plea moved by the Tamil Nadu Chemists and Druggists Association (TNCDA).

One more petition is pending before the Hon’ble Delhi High Court which is also seeking closure of online pharmacies that are offering drugs and prescription medicines through websites.

The above decisions of both the Hon’ble High Courts are welcome particularly as an online pharmacy sounds convenient; there is no waiting in queues, no rushing to the chemist shop before it shuts shop for the day, placing the order is easy, moreover, the order can be placed any time of the day and the medicines are conveniently delivered via courier at your doorstep. Yet, this convenience comes at a price. Not only there may be financial implications for the patients, their safety may even be endangered at times.

Indian Medical Association (IMA) has never been in favor of online sale of medicines and had raised this issue during my tenure first as Honorary Secretary and later as National President IMA.

The need of the hour is to come out with a defined policy for both online consultations and online pharmacy. In an earlier judgement, the Supreme Court has said no to telephonic consultation, unless it is an emergency. 

So, if telephonic consults are not allowed, then how can online consults or online pharmacy be permitted for patients with no established doctor-patient relationship? 

After much persuasion and objections, the Central Government has introduced some draft rules to amend the Drugs and Cosmetics laws to regulate and allow only licensed e-Pharmacies.

Online sale of medicines has several ill-effects, such as:

·         There are no well-defined dedicated laws for online pharmacies. Pharmacies in India are governed by the Drug and Cosmetics Act 1940, Drugs and Cosmetic Rules 1945, Pharmacy Act 1948 and Indian Medical Act 1956.Laws related to ecommerce are defined under the Information Technology Act, 2000.

·         The major issue of concern is that prescription drugs cannot be sold online as there is no provision in any law for sale of prescription drugs online.

·         Online pharmacies may not abide by regulations and rules relating to scheduled drugs as mentioned in Schedule E1, G, H, H1 and X and bypass them. The objective of Schedule H1 was primarily to check the indiscriminate use of antibiotics in India, in view of the rising incidence of multi-drug resistant bacteria, a serious public health issue worldwide. Easy access to antibiotics via online pharmacies will defeat this very purpose.

·         The Drugs and Cosmetics Act has no provisions for online sale of medicines, or home delivery of medicines. Hence, online sale of medicines cannot be legally permitted.

·         The prescriptions submitted via fax/email may be fake, and it could be difficult to verify their authenticity. Online correspondence and/or scanned copies are legally not permitted.

·         Online pharmacies will promote drug abuse, drug misuse, self-medication etc. Any mediation taken without the supervision of doctors may be dangerous and even potentially life-threatening.

·         Pharmacists are not allowed to accept and dispense prescriptions that are brought in by children. Online pharmacies will provide easy access to controlled drugs or even street drugs to this vulnerable group.

·         Regulation 5.3 of MCI Code of Ethics stipulates that pharmacists and doctors should work together. If online pharmacies are allowed, then this relationship will be lost.

·         Many online pharmacies may be operating without the appropriate license. This increases the chances that drugs sold by such unlicensed pharmacies maybe counterfeit, substandard, or adulterated and therefore risky to the patient. There are no checks in place to make sure that the drugs sold by online pharmacies are not spurious.

·         If online pharmacies are allowed, the National Pharmacovigilance Program, initiated by Central Drugs Standard Control Organisation (CDSCO) under the Ministry of Health and Family Welfare, will become a futile exercise. This program is not only meant for doctors but also for pharmacists.

·         Medicines have to be stored properly as recommended by the manufacture. Exposure of medicines to high temperatures in storage or in transit could diminish their efficacy and are a potential health risk. There is no way to check the storage conditions of the drugs sold by the online pharmacies.

·         Regulatory authorities continue to monitor a drug for any adverse effect even after it has been on the market. If the safety/quality of the medicine comes under question or, if it is potentially contaminated, mislabeled or is improperly packaged, then they may recall or withdraw a prescription or OTC drug from the market even after it has been approved. Sometimes, the manufacturer may voluntarily recall a drug. If online pharmacies are permitted, the drug recalls become very, very difficult, almost next to impossible.

·         Breach of confidentiality is another major concern. Online pharmacies may misuse personal and financial information of the patient as well as of doctors leading to cases of identity thefts and fraud.

·         Online pharmacies offer drugs at low cost or at discounted prices to lure customers. If the online pharmacy gives cheaper alternatives of drug/s prescribed, this violates the doctor-patient-pharmacist relationship, which is based on trust.

·         Pharmacy laws in India do not allow a pharmacist to substitute a brand written by a doctor.

·         Pharmacists are also not authorized to change potency of the prescribed drug, even if the patient asks for it.

·         Refilling of a prescription is not allowed by pharmacists unless authorized by the doctor. If the doctor has prescribed a drug, e.g., 3 days, the pharmacist cannot dispense drugs for more than this duration.

·         Online pharmacies may provide rebates and commissions to doctors to provide prescriptions on the basis of online information that has been filled by the patient. This way doctors will be vulnerable to malpractice suits. Regulation 6.4 of MCI Code of Ethics prohibits doctors from giving or receiving any rebates or commissions.

·         Similar to the online search service, online pharmacies may also promote doctor substitution, which is unethica

Dr KK Aggarwal
Padma Shri Awardee
President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)
Group Editor-in-Chief IJCP Publications
President Heart Care Foundation of India
Immediate Past National President IMA

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