|
 The South Chemists & Distributors Association (SCDA), which represents chemists and pharmaceutical distributors working in Delhi, has requested the drugs control authority of Delhi not to issue drug licenses to online drug sellers such as e-commerce and quick commerce sellers.
The Association alleged that the e-commerce, quick commerce entities are now selling drugs through mobile applications, and the entire process being adopted for selling a prescription drug is in blatant violation of the Rules and Regulations.
"Consultation which is arranged by these companies and the mobile applications and resultant generation of the prescription is in total contravention of Para 3.8 of the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 which regulates 'Consultation by Telemedicine'," it said in a memorandum filed by the Association to Rajeev Bhargav, head of the Office of Drugs Control Department, Government of National Capital Territory (NCT) of Delhi.
It added that only medicines which are used for common conditions and are often available Over The Counter, such as paracetamol, ORS solutions, cough lozenges etc., can be prescribed through audio consultation, and alleged that the prescriptions being generated through the e-pharmacies and mobile applications are a mere façade for which action deserves to be taken by the National Medical Commission against medical practitioners indulging in such practices.
"It is also to be noted that the Registered Medical Practitioners (RMP) are required to exercise their professional judgement to decide whether a telemedicine consultation is appropriate in a given situation or an in-person consultation is needed in the interest of the patient. However, since the medical practitioners are working at the behest of the e-pharmacies and the mobile application companies, they issue prescriptions routinely without even exercising their judgement," added the Association.
These companies are also not following the guidelines that the telemedicine consultation should not be anonymous, while it is mandated that a RMP should verify and confirm the patient's identity by name, age, address, email ID, phone number, registered ID or any other identification as may be deemed to be appropriate, during teleconsultation.
The guidelines also stipulate that the RMP should explicitly ask the age of the patient, and seek age proof if needed, for issuing prescription, and if the patient is a minor, the tele consultations would be conducted only if the patient is consulting along with an adult whose identity needs to be ascertained.
The Association added that the regulations also clearly say that the telemedicine has its own set of limitations for adequate examination. If a physical examination is critical for consultation, RMP should not proceed until a physical examination can be arranged through an in-person consultation.
It also alleged that the licenses requested by the online pharmacies now are only to camouflage the actual business of selling drugs and prescription of medicines through e-pharmacies or mobile applications.
It added that the license may be given only if the companies undertake on an affidavit that they undertake to sell drugs in compliance with the rules laid down under the Drugs & Cosmetics Act, that they will not misuse the license to sell drugs over the internet, and that the scheduled drugs will not be displayed on the license holder's website or mobile application.
If further requested the drug regulator to seek the license applicants to undertake in writing that the license holder will not supply scheduled medicines for orders received from any websites where these drugs are displayed, and they will not engage any medical practitioners or involve in getting a prescription generated for the consumer.
Besides, it should also ensure that the payment will not be through the e-pharmacy or mobile application portal but would be made only at the premises at the time of purchase of medicine.
The Association pointed out that the Drugs and Cosmetics Act and Rules clearly defines that the license to sell, stock or exhibit or offer for sale, or distribute drugs is for the premises where the license is granted, and a drug license for sale of drugs in retail cannot be used to sell, stock or exhibit or offer for sale drugs over the internet. There is no license for the exhibition, selling or distribution of drugs over the internet.
It may be noted that the Association is a petitioner in a litigation in the Delhi High Court against the existence of online pharmacies in the country. It informed the drug regulator of Delhi that the High Court of Delhi has imposed a ban on the online sale of medicines without license, and the Drugs Consultative Committee in 2019 recommended that any violations regarding online sale of drugs shall be dealt as per the existing provisions under the Drugs and Cosmetics Act, and Rules, until the publication of a final notification for regulation of sale of drugs by e-pharmacies in the country.
While the Central government has issued a draft notification regulating e-pharmacies, it has not finalised the regulation so far. While the regulations on e-pharmacies were also included in a new Drugs, Medical Devices and Cosmetics Bill, 2023, the Bill is yet to see any progress so far.
India’s e-Pharmacy industry is expected to maintain robust growth, projecting an annual growth rate of around 18-20% to reach around $3.4 billion in market size by 2030, with new technologies and integration of more services into their offerings, expects experts in the e-pharmacy sector.
|