Prescription regulations for e-pharmacies

The supply of prescription medications are now easier, contactless and hassle-free thanks to e-pharmacies.

Pharmacies are the showrunners of the healthcare industry, especially in a country with a large population like India. The advent of e-commerce opened up a plethora of possibilities for providing medicine and healthcare to patients. While the Government of India has mandated that doctors write their prescriptions in legible handwriting, in uppercase letters, the same was not followed by a vast majority. This leads to misreading the prescription and hence the patients may obtain the incorrect medication which is dangerous. 

Through an e-pharmacy framework, healthcare professionals can write and send prescriptions to a participating pharmacy electronically instead of handwritten prescriptions getting rid of inaccuracy. Accessing previous prescriptions is also made simple due to the digital storage and archives tools. Easy supply of medicines for the patients to their homes is the key advantage of online pharmacies. In a time like the COVID-19 pandemic, going out to a pharmacy outlet can expose the already compromised patient and increase the risk of contracting the deadly infection. Online pharmacies can nullify that risk with the addition of contactless delivery. 

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Regulation of e-pharmacies: 

The powers of pharmacy regulations lie in the hands of both the Central as well as State governments. The  Central Drugs Control Organisation headed by the Drugs Controller General India at the Central Government licenses the drug imports. State-based Drugs Control Administrations supervises the manufacture and sales of these drugs. The laws concerning pharmacies in India prevail under the Drugs and Cosmetics Act, 1940; Drugs and Cosmetics Rules, 1945; Pharmacy Act, 1948; Indian Medical Act, 1956; Code of Ethics Regulations, 2002, etc, all of which were written before the era of the internet and computers. Hence, there are no set-in-stone laws for e-pharmacies. 

E-pharmacies regulations are influenced by the Drug and Cosmetics Act, 1940 and the Information Technology Act, 2000. However, the Drug and Cosmetics Act do not differentiate between offline and online pharmacies. On 28th August 2018, the Union Health Ministry released a draft on “sale of drugs by e-pharmacy” which states the following 

  1. No person will distribute or sell, stock, exhibit or offer for sale of drugs through the e-pharmacy portal unless registered. 
  2. Any person who intends to conduct the business of e-pharmacy shall apply for the grant of registration to the Central Licensing Authority in Form 18 (AA) through the online portal of the Central Government.
  3. The application of registration of e-pharmacy will have to be accompanied by a sum of INR Rs. 50,000 while asserting that an e-pharmacy registration holder will have to comply with provisions of Information Technology Act, 2000 (21 of 2000). 
  4. The details of the patient shall be kept confidential and not be disclosed to any person other than the central government or the state government concerned, as the case may be. 
  5. The supply of any drug shall be made against a cash or credit memo generated through the e-pharmacy portal and such memos shall be maintained by the e-pharmacy registration holder as a record.
  6. New e-pharmacies have to be registered with the Central Drugs Standard Control Organization (CDSCO), India’s apex drug regulator and central licensing authority. 
  7. E-pharmacies have to take only one license in any state and can sell drugs all over the country even if they have one license.
  8. The sale of tranquilizers, psychotropic drugs, narcotics and habit-forming drugs have been prohibited through e-pharmacies portals.
  9. The premises of e-pharmacy shall be inspected, every two years by a team of officers authorized by the Central Licensing Authority, with or without the experts in the relevant field or the officers authorised by the concerned State Licensing Authority.
  10. The registration issued to any person for e-pharmacy will remain valid for a period of three years from the date of its issuance and renewal of registration will have to be done in case it wants to continue. 
  11. No e-pharmacy shall advertise any drug on radio or television or internet or print or any other media for any purpose.
  12. The e-pharmacies portals are required to have at least twelve hours and all seven days a week customer support and grievance redress of all stakeholders. The customer support should have a registered pharmacist in place to answer the queries of customers through such customer helplines. 

The Union Health Ministry issued a notification during March 2020 allowing home delivery of scheduled H drugs by licensed e-pharmacy portals based on the prescription that is either provided physically or through email. 

The prescription builder tool of Bengaluru-based MedPiper Technologies, Inc automates all of the patient’s prescriptions, and stores them in one place, thereby allowing access to historical information and data whenever required. The tool aims to bridge the gap between practitioners of smaller clinics and patients. Fully packed with all the essential inputs like Patient history, Unique patient IDs, and Medicine consumption slots, this prescription builder makes it all the easier for doctors to use it, and also for pharmacies, patients, and other parties to keep an easy check on the contents of the prescription in itself. 

E-pharmacies can eliminate the dangerous outcomes of self-medication, inaccurate reading of handwritten prescriptions and further exposure to life-threatening infections. Regulations have to be formulated and put into effect to ensure the legitimate and efficient functioning of online pharmacies.

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