Traditionally, the distribution of medicines used to happen through physical retail stores, which were registered pharmacist who provide medicines based on prescription, from a licensed premise. However, innovative startups have started coming up which deliver medicines at home, with the help of technology. They adopt different business models like online-only pharmacy, physical pharmacy with an online presence, market place business and so on. Some companies deliver medicines on the basis of scanned image or photocopy of the prescription which the customer uploads on the portal through mobile application. These images are then transmitted to the partner medical stores, which in turn delivers medicine at the door step of the customer either personally or by courier. Some ventures in this sector even follow a model under which Doctors prepare prescription on their electronic gadget and transmit it to pharmacy and the licensed pharmacy dispenses medicines against the same. Some vendors even display this option on their website and makes offer for sale to the visiting customer. The customer is expected to search the relevant medicines for purchasing the same online and thereafter, delivery is made to such customer. Online pharmacies allow pharmacists to cater to a larger group of patients as the inherent geographical restrictions on physical pharmacies are removed in the online model. However, while starting an e pharmacy it is essential to keep in mind the legal landscape for such a venture is not very comprehensive.
The Central Drug Standards Control Organization (“CDSCO”) is planning to launch a centralized online system to deliver medicines effectively. All the chemist, druggist and e-pharmacy have to register with it. The Pharmacy Practice Regulations, 2015 (“PPR Regulations”) were enforced to regulate pharmacy practice in India. It states that the practice of pharmacy by registered pharmacists in India requires that the prescription drugs are to be handed over to the patient or his caretaker directly by a registered pharmacist. Thus, making it challenging to have pharmacists deliver medication directly to patient.
Further, the Drugs and Cosmetics Act requires that all drugs must be sold under a license. Thus, general retailers in India cannot sell drugs, except those which fall under Schedule K (Over the counter drugs) which can be sold without a license. The lack of a well laid governance system for concept of e-pharmacies can be attributed to the simple fact that it is a new age concept and law makers had not visualized such kind of ventures disrupting the established markets while drafting existing legislations. Therefore, most of the legal compliances around this pharma sector including distribution, have been visualized and built in keeping in mind the traditional way of distributing medicines to patient. For example, Schedule N of the Rules lay down the requirements to be met before running a pharmacy. The requirements were designed for traditional brick and mortar stores, and hence it becomes difficult for even legitimate e-Pharmacies to comply with the current regulatory requirements. These innovative ventures need to comply with the provisions of IT Act as well. Therefore, pharmacists need to ensure that when the prescription is transferred electronically - as in the case of uploading a prescription to an online pharmacy - it must comply with the provisions of the IT Act as well as the Drugs and Cosmetics Act and corresponding Rules. Further, dispensation should be done only on the basis of valid prescription. There is an urgent need for additional safety measures to be put in place whereby a prescription drug is not dispensed more than once against the same prescription. It is the need of the hour to formulate rules/guidelines for overlooking safe and supervised functioning of e-pharmacies.
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