E-Pharmacy Regulations

In the last few months, there have been many start ups in Bangalore and elsewhere who have introduced many mobile app based services in Health Care industry. Some of them have ventured into areas which may come under the provisions of the Pharmacy Act 1948. (Refer here under the link Rules &Regulations). Some of  these Companies are functioning as e-Pharmacies who need to also keep an eye on the effect of the “Pharmacy Practice Regulations 2015” on their business activities.

Additionally the pharmacists will also be subject to the proposed Health Care Data Privacy and Protection Act. (Refer www.hdpsa.in) .

According to the Pharmacy regulations, registered pharamcists need to maintain medical/prescription records pertaining to a period of 5 years. He should be in a position to make it available on demand by the patient/authorized attendant. Pharmacist is bound to maintain “Privacy” of patient information and the associated security when the information is maintained in electronic form.

The critical aspect of the regulations from the perspective of the App developers is that the definition of “prescription” takes cognizance of e-prescriptions.

The definition states, “Prescription” means a written or electronic direction from a Registered Medical Practitioner or other properly licensed practitioners such as Dentist,Veterinarian, etc. to a Pharmacist to compound and dispense a specific type and quantity of preparation or prefabricated drug to a patient.

The “Electronic direction” is considered as an “e-prescription” and meet all the requirements of a written prescription.

The requirements of a written prescription include the following:

Prescribers office information – [Name, qualification, address & Regn. No.]
(ii) Patient information – [Name & address, Age, Sex, Ref.No.]
(iii) Date
(iv) Rx Symbol or superscription
(v) Medication prescribed or inscription
(vi) Dispensing directions to Pharmacist (or) subscription
(vii) Directions for patient [to be placed on lable]
(viii) Refill, special labeling and /or other instructions
(ix) Prescriber’s signature and licence (or) Drug Enforcement Agency (DEA) number as required.

Hopefully, the e-pharmacies and e-prescription app developers take these into consideration before the department starts questioning them on the legality of their activities.


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About Vijayashankar Na

Naavi is a veteran Cyber Law specialist in India and is presently working from Bangalore as an Information Assurance Consultant. Pioneered concepts such as ITA 2008 compliance, Naavi is also the founder of Cyber Law College, a virtual Cyber Law Education institution. He now has been focusing on the projects such as Secure Digital India and Cyber Insurance
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