The Indian Medical Association (IMA) recently released a white paper detailing why the Indian government should not allow online pharmacies. On the surface, it would seem that an association founded way back in 1928 and claiming to represent the interests of all practitioners of the ‘modern scientific system of medicine’, is wary of using modern technology. After all, there is probably nothing that cannot be bought online today. So why shouldn’t medicines, at least the OTC segment, go the same route? Is this merely a turf battle, with doctors trying to preserve their position in the healthcare delivery hierarchy? Not so: the Maharashtra state FDA also seems to be on the same wavelength, when it filed FIRs against e-commerce firms for selling medicines online.
IMA president elect, Dr Jayesh Lele minces no words when he says that the refilling/ reuse of prescriptions via online pharmacies should be banned and doctors should have complete control of the prescriptions. He gives a few examples to prove his point. Patients being treated for long term ailments like diabetes and hypertension need their medication constantly calibrated after testing sugar and blood pressure levels.
In the case of infections requiring antibiotics, many patients self medicate based on their own judgment of symptoms and refill previous prescriptions to buy antibiotics off the net. Dr Lele attributes the rise in multi-drug resistance to self medication and predicts that easy availability online will only exacerbate this situation. Similarly, he points out that some medication might result in side effects which differ from patient to patient. For instance, some patients prone to acidity might need to change their medication which needs the expertise of a doctor.
Besides violating the Drug and Cosmetics Act 1940, Drugs and Cosmetic Rules 1945, Pharmacy Act 1948 and Indian Medical Act 1956, the IMA white paper points out that online pharmacies pose practical issues like the inability to check the storage conditions under which medicines are stored by e-commerce players. Also, there are no checks on counterfeit or expired medicines making their way to consumers. Patients/ consumers may be lured by discounts and might ultimately end up with spurious medicines.
Online pharmacies, as they function today, will also disrupt the flow of information on adverse drug reactions which doctors and pharmacists are supposed to report to the National Pharmacovigilance Programme. Will online pharmacies maintain patients’ confidentiality? What stops them from incentivising their internal panel of doctors to ‘push’ medicines based on uploaded patient information? How will they prevent minors from buying controlled drugs? Will they be able to check that the packaging of prescription medicines has the mandated warnings?
The IMA is most concerned that online pharmacies will erode the trust between the patient, doctor and pharmacist. One must admit that this trust deficit is already quite high, thanks to rogue doctors themselves.
However, Dr Lele concedes that in this age of convenience, buying medicines online cannot be wished away. Therefore, he is not against online sale of medicines per se, but wants better infrastructure and regulation in place. He makes a fine distinction between ‘online pharmacies’ and ‘e-pharmacies’. In the former, purchasers can reuse and upload scanned copies of prescription where as in the later, the system connects each uploaded prescription to a licensed pharmacist, either online or off line, who checks it and only then authorises the dispatch of the medicines.
Dr Lele is understandably concerned that the medical profession will have to bear the blame, in terms of malpractice suits and the like, if there are tragic consequences to such sales. Hence the stridency and urgency to weed out bad practices and regulate this market model.
The fact that Maharashtra FDA had to file an FIR against established e-commerce players raises concerns that the illegal will slowly wear the garb of the legal very soon, if the government does not soon crack down hard. Fortunately, the Drug Controller General (India) has said that draft rules for online sale of medicines will be ready for stakeholder review in four months.
Rogue online pharmacies are not confined to India but overseas regulators have managed to put some systems in place. For instance, the US and Canada use credentialing agencies to separate the wheat from the chaff. The US uses PharmacyChecker.com, National Association of Boards of Pharmacy (NABP) Verified Internet Pharmacy Practice Sites (VIPPS) programme or LegitScript, where as Canada-based online pharmacies need to be approved by the Canadian International Pharmacy Association.
India’s policy makers too can designate industry associations to credentialise online pharmacies but the Ketan Desai-MCI saga begs the question: who will watch the watch dog?