The All India Organisation of Chemists & Druggists (AIOCD), an apex body of 8 lakh chemists and druggists across the country, has opposed Dr Harshdeep Kamble sub-committee's draft recommendations on the viability of e-pharmacy model, saying that the committee failed to address vital issues of patient safety, shortage of manpower and infrastructure regulating drug sale, patient counselling, proper utilization of drug minimizing medication errors, data confidentiality, etc.
Besides this, the committee failed to consider importance of recently introduced Pharmacy Practice Regulations 2015, and mechanism for drug return. It has not spelt out mechanism to prosecute foreign directors in case of drug disasters, rued AIOCD president J S Shinde.
The sub-committee, chaired by Maharashtra FDA Commissioner Dr Harshdeep Kamble had submitted its recommendations to DGCI wherein it suggested to put in place a national portal for registration of online pharmacies, sale of drugs on e-prescriptions, audit trial to prevent drug abuse and linking prescriptions with Aadhaar Card. It has excluded certain categories of drugs such as narcotic and psychotropic drugs, tranquilisers, habit-forming drugs and Schedule X drugs that are prone to misuse via online pharmacies.
Shinde in a letter to joint secretary, ministry of health and family welfare K L Sharma said that the conventional drug sale is regulated by state licensing authorities whereas the online sale is proposed to be registered with central drug authority. So, it will create chaos and lack of coordination between the central and state licensing authorities. Considering the shortage of drug inspectors and poor infrastructure facilities, the government needs to formulate a five-year plan for recruitment of drug inspectors/ assistant drug inspectors/setting up of drug analytical labs/clerical grade/IT cells/legal cells before thinking on allowing online sale of medicines.
It is difficult to trace or control the online sale. In conventional sale once a patient or his guardian or nursing staff takes the hold of prescribed drug it is secured, but in online sale there is greater possibility of pilferage of drugs in transit and such circumstances are bound to create additional burden on poorly equipped regulatory bodies. The draft failed to redress this issue, he added.
The draft mentioned categorization of negative list of items not be sold on line, but it miserably fails to understand that mere excluding abusive or habit forming or abortion causing drugs will not protect the safety of consumers, but every prescription of schedule drug warrants a counseling, a single prescription is never suffice to give entire health history of patient, already we know that in face to face counseling there are chances of miscommunication, so online or telephonic counseling is bound to create barriers of communications, ultimately the patient will suffer.
The committee has not mentioned about return policy for drugs. In conventional sales the interest of consumer is protected when he returns the unwanted, wrongly dispensed or unused drug to the neighborhood pharmacy, but in online sale he may fail to return the drug inadvertently for lack of filing online request resulting in wastage of drug as a national resource, the draft failed to redress the issue. Draft is only addressing the accessibility of drugs to people, but miserably failed to redress the issue of proper utilization of drug minimizing medication errors, said AIOCD president.
It failed to give importance to recently introduced Pharmacy Practice regulations 2015. The Indian Internet Pharmacy associations conveyed the misinterpreted definition of prescription with reference to pharmacy practice regulation, the definition only mentions electronic prescription, which is more applicable to mega or corporate hospitals for IPD purpose, but in PPR 2015, the definition of prescription does not say online/internet propagation of prescription.
Online pharmacy, once allowed, will lead to data breach. It can never be guaranteed 100 per cent, especially when defense websites are easily hacked, how much trauma a HIV patient will go through if his confidential information is leaked to his colleagues or society? also draft did not provide safeguards in this matter.
Draft which projected a rosy picture of electronic surveillance also failed to take into account that in India how many doctors will be able to raise a internet prescription with proper legal compliance?
Draft failed to mention how foreign directors will be effectively prosecuted in case of drug disasters? Union carbide is a strong lesson for us.
Before thinking of unnecessary online sale permission first the government should offer subsidy in the revenues and taxes for conventional licensed pharmacies, first ensure proper enforcement of laws in conventional drug sale before dreaming or canvassing e-pharmacies, he opined.
AIOCD appealed till and until all above concerns are not properly dealt with and incorporated suitably in the draft, it is not advisable to allow online sale of medicines in the larger interest of public health. Hence it further appealed not to amend Drug and Cosmetic Act, 1940, and or Rules 1945 as suggested in the draft.