The existing Drugs & Cosmetics Rules are adequate to carry out sale of medicines online in a legal and ethical manner. For this, a couple of changes related to delivery of medicines and medical devices can be incorporated for the time being in the good distribution practices’ guidelines issued in October 2012 by CDSCO, said Dr. BR Jagashetty, former national advisor (drugs control) to ministry of health & family welfare and former Karnataka drugs controller.
The online sale of medicines can be made operational in accordance with the existing Drugs & Cosmetics Rules read with Section 4 & 5 of Information Technology Act, 2008, and Pharmacy Practice Regulations, 2015 issued by government of India through PCI, Dr Jagashetty told Pharmabiz.
In this era of information technology revolution, online sales enables transparency in transactions to tackle any violation in sales online or otherwise. Yet, there are apprehensions on the misuse of any proper model of online sales of medicines / devices, he noted.
With the All India Organisation of Chemists & Druggists (AIOCD) calling for a complete bandh on October 14, 2015 to protest against online pharmacy, Dr Jagashetty said that he agreed with their apprehensions particularly the one related to the lack of assurance on the verification and authenticity of the medical practitioner besides inappropriate storage conditions of medicines during transit. The key concerns of online pharmacy are delivery of a quality drug and whether the sale is based on a valid prescription, he noted.
Further, a major problem in physical pharmacy retail outlets is the failure to endorse all prescriptions for which drugs are dispensed. This is primarily because of a prevailing practice where a regular sale bill is not provided. Such practices also lead to no records being maintained on purchase of medicines and that too via prescriptions, said Dr Jagashetty adding it was an appreciative move by the government of India to specially strengthen the Centre and States’ drug regulatory systems.
Another issue which adds to the woes of the pharmacy outlets is the absence of pharmacist to supervise the sale of medicines especially in big cities. This according to Dr Jagashetty could be replicated by online pharmacy players.
“Probably these are the few reasons which is forcing the regulatory authority to work towards bringing in a set of rules to ensure that there are no loop holes for misuse or abuse of drugs and devices’ sales via online. The current D&C Rules are more than adequate to execute sales online in a legal-ethical manner besides protecting the interests of existing pharmacy retailers, said Dr. Jagashetty.
Now DCGI has formed a dedicated sub-committee for online pharmacy to assess its viability. “We are hoping it would work towards additional guidelines like whether to permit prescription for upload along with stringent punishments for offenders etc. These rules are mandated to ensure complete safety of patient health since any medicine could cause adverse reaction depending on various health conditions, he said.