Ministry releases draft rules to regulate e-pharmacy

With the online sale of medicine getting gaining popularity, the Union Health Ministry has begun the process of regularising the e-pharmacies.

Last week the ministry issued a set of draft rules to amend the Drug and Cosmetics Rules 1945 to allow the sale of drugs through e-pharmacy.

An e-pharmacy has been defined in the new rule as a business of distribution or sale, stock, exhibit or offer for sale of drugs through a web portal or any other electronic mode.

The notification describes the rules and regulations for registering the e-pharmacies and the procedure for sale through the online mode.

The e-pharmacies are prohibited to sell medicines specified under the categories of the Narcotic and Psychotropic as referred to in the Narcotic Drugs and Psychotropic Substances Act, 1985; tranquilisers and the drugs listed in the Schedule X.

Schedule X medicines are mostly sedatives, barbiturates, stimulants, psychotropic medicines, anti-anxiety drugs and medicines for the Central Nervous System.

The e-pharmacies are allowed to sell the medicines only against a prescription, a copy of which they will have to keep.

“On receipt of the prescription, through an e-pharmacy portal, the registered pharmacist shall verify the details of the patient, Registered Medical Practitioner and arrange for the dispense of the drugs as per the instructions of the doctor,” says the draft rule.

“The details of the drugs dispensed including the patient details shall be maintained on the e-pharmacy portal. In case of e-prescription, the prescription shall be uploaded on the e-pharmacy portal and shall be kept in record by the dispenser,” it adds.

In case of a suspicion of the drugs being sub-standard or spurious, the buyer can make complaints to the State Drugs Controller and seek relief under the Consumer Protection Act, 1986. The rules are open for public comments for 45 days.

A 2015 report by Federation of Indian Chambers of Commerce and Industry and Frost and Sullivan reported that though the e-Pharmacy is at its nascent stage in India, but it has the potential to account for 5-15% of the total pharmaceutical sales in the coming years, largely by enhancing adherence and improving the access for a lot of under-served population.

The draft rules are published more than a year after the ministry initiated a consultation on how to regulate the online sales of medicines, which is illegal at the moment. The drug regulators, however, felt such sales were possible in future with several changes in the law.

The popular business came under the government scanner in 2015 when Maharashtra drug regulatory authority raided the business premises of a major online retailer and seized prescription only brands from its stock. Subsequently, a review of the trend was initiated.