The Drug Controller General of India's (DCGI) plan to set up a registry of e-pharmacies augurs well for the growth of online pharmacy which will in turn lead to patient safety by checking entry of rogue e-pharmacy players and counterfeit drugs in supply chain.
The plan to form registry of e-pharmacies was mulled over by DCGI after acknowledging recent recommendation given by Dr Harshdeep Kamble subcommittee to put in place a national portal for registration of online pharmacies. This will pave the way for regulation of e-pharmacies as per provisions of the law.
The reason behind the initiative is to ensure that only registered players can sell medicines on e-prescriptions received from registered doctors.
Welcoming the drug regulator's initiative to create registry of e-pharmacies, founder, CEO, 1mg, Prashant Tandon said “If the right ones are clearly identified, wrong ones will be rooted out from the system. With this, there will be a clear regulatory oversight with full operation details and qualifications of the registered entities. All registered e-pharmacies show a logo and registration number which is verifiable from the regulator website. The e-pharmacies and drug regulators can work together to educate consumers about anti-counterfeit drugs.”
Shedding light on how e-pharmacy model addresses counterfeit drug issue, Tandon said “Drug regulators can trace and verify the data of e-pharmacies as online pharmacies ensure organized tracking and recording of the data for audit trails from manufacturer to consumer for every sale and make it accessible for verification. It is impossible for e-pharmacies for local jurisdiction to indulge in counterfeit since it is very easy to catch. E-pharmacies make consumers' aware on how to identify the authentic medicines thereby increasing identification of fake drugs.”
Talking about avenues facilitating circulation of counterfeit drugs in supply chain, he said counterfeit pharmaceutical products enter the system across almost all retail points, but mostly at dealer/distributor level. They are generally mixed with genuine products, to make identification tougher. Such products are almost always sold through cash economy with no trace or tracking to the entity who brought it into the ecosystem. They are distributed from outside the country of jurisdiction through couriers. Local regulators can not even find a way to connect/stop these operations.”
Talking about reasons behind circulation of counterfeit products in pharmacies, he said “It is hard to build a brand and easy to manufacture a copy. Pharma companies poorly communicate brand information to patients, so there is no check at consumer end unless there is an adverse event. There is only reactive vigilance based on few adverse events. Laws are stringent, but implementation is hard in absence of any tracking. Its very easy for miscreants to sell fake pharma products in the cash market which has no traceability and tracking from manufacture to consumer.”
The government's positive attitude towards e-pharmacies will make things better in long run, he added.
However, AIOCD, a representative body of 8 lakh chemists is strongly opposing the presence of online pharmacies on the ground that their operations are in violation of Drugs and Cosmetics Act. The trade body had filed case against operation of e-pharmacies in ten states. It contended that online pharmacies didn't comply with prescription norms.
Currently, the online sale of prescriptions drugs falling under schedule H, H1, G and X is illegal. However, for non-prescription drugs, those having the licences can sell them which are without prescription even on online.
On December 30, 2016, the DCGI had directed drug control officers of all states to initiate action against those selling drugs online to protect public health.