The Union government’s draft rules for e-pharmacy regulations has brought in a whiff of positive environment which is needed for the much debated online drug sale, stated experts.
According to Dr BR Jagashetty, former National Adviser (Drugs Control) to CDSCO and Former Karnataka Drugs Controller, overall the draft seems to be satisfactory. However there are two major issues as far as online pharmacy is concerned like the one with regard to the type of prescription to be honoured and other one with regard to mode of delivery that is whether home delivery in person or by post or by courier.
Though e-prescription is not defined, it has been found to be taken care as the draft mandates need to comply provisions of IT Act, 2000. Another major issue is that of supply chain. There is no specific mention on how the drugs are to be delivered to the patient/consumer. The draft should indicate the mode of delivery to the place of choice. It should also have provided under whose supervision such delivery can be taken up. Since the draft provides details of patient counselling to be submitted along with application to CDSCO, it would have been better to club patient counselling with delivery of drugs as it goes hand-in-hand, stated Dr Jagashetty.
It may not be correct to make these e-pharmacy players as fully responsible for legal compliance of actual dispenser or retailer with whom they are tied up instead specific responsibilities for e-pharmacies may be fixed, said Dr Jagashetty
At one place monitoring of e-pharmacies is permitted to both central licensing authority and state licensing authority but the draft is seen to restrict providing data only to central licensing authority which is not correct, he said.
With the circulation of the draft rules now, there will be some framework available specifically addressing the e-pharmacy business model. The rules appears to be one that is more in the nature of a market place as opposed to an actual sales on website as the dispensation has to eventually be done from a licensed premises. What is worrisome is that the marketplace would be responsible for legal compliance of the eventual dispenser. One will need to see the final rules to gauge a better understanding, said Sameer Sah, Associate Partner, Khaitan & Co.
The regulation also stated that data from e-pharmacies is not to be shared with anyone except the central government for public health purposes. This eliminates possibilities of these companies monetizing this data. But one also wonders how IMS and other agencies will gather pricing and sales data from the e-pharmacies, he added.
“The medicines have to be provided against prescriptions and this definitely addresses the issue of self-medication via prescription drugs. Of course, the absence of the point on last mile delivery and associated complications is an obvious miss as along with it arises factors such as endorsing the prescription, among others,” stated Sah.