Online sale of drugs using scanned prescription may not fulfill all the critical rules of existing laws of the land as scanned signature is not valid even as per IT Act. Now The IT Act is being misinterpreted and being misquoted by the so-called few in the market place of online pharmacies, stated Dr B R Jagashetty, former national adviser (Drugs Control) to CDSCO and former Karnataka drugs controller.
Fabricated scanned prescription can cause legal implications for the doctor whose Rx has been copied. Scanned Rx including signatures can be easily copied using any editing software and leads to abuse and multiple dispensing, he added.
This is where electronic prescription is the futuristic model of drug dispensing. Electronic Rx (E-Rx) is created by the doctor using software and it is electronically signed. It helps in doctor and pharmacy integration, prevents misinterpretation, avoids errors of reading the hand writing of doctors while dispensing. It stalls batch number and wrong expiry mismatch. It helps in easy moving of refills from one pharmacy to another as per customer choice with Rx validity clearly known to the new pharmacy, stated Dr. Jagashetty at a session titled ‘Drugs and Cosmetics - A Legal Prospective' organised by the Karnataka Institute for Law and Parliamentary Reform in collaboration with Vivekanand College of Law and Vivekanand College of Pharmacy, Bengaluru.
E-Rx gives FDA a much cleaner and better long term records than manual keeping. FDA can demand complete copy of Rx records on its own server if needed. The regulatory authority can view the entire end-to-end movement of Rx from prescribing to dispensing. Besides, E-Rx setup modernizes overall healthcare establishment in the country and creates environment for only serious players which would also reduce healthcare costs tremendously while at the same time increasing patient safety, pointed out Dr. Jagashetty.
Now e-prescription is a clear win-win for the regulator, government, patients, doctors, pharmacists and chemist shops. The concept is already in vogue in the US as ‘VIPPS’ programme. The new EU regulation mandates online pharmacies to display the related logo which was enforced from July 1, 2015. It automatically presses for registering with the MHRA (Medicines and Healthcare Products Regulatory Agency) and displays the same in all the web-pages which confirms that the seller is a registered online pharmacy.
In India, now it is time that CDSCO can fix a hefty fees for registration of online pharmacy players and bring strict rules/guidelines for displaying the dispensing pharmacy information on the website with full address, contacts and proper logo assigned to it.
CDSCO may also direct to have a retail license from the respective state regulatory authorities though online is one of the mode of sales. The regulator can think of permitting only e-prescription with electronic signature since any registered medical practitioner can do his electronic signature only on approval of the same by government of India as per the norms fixed. It can impose severe punishments for violations including hefty fines if violations are found, he said.