The Internet and Mobile Association of India (IAMAI) in its submission to the Ministry of Health and Family Welfare on Tuesday, called the definition of e-pharmacy in the e-pharmacy draft rules as “outdated and contradictory”.
The industry body that represents digital enterprises said that the definition of e-commerce platforms under the Department of Industrial Policy and Promotion (DIPP) and National Informatics Centre (NIC) rules is that it is a legitimate form of business where wholesalers and retailers of any goods and services reach out to buyers.
IAMAI has recommended that the definition be holistic to support innovation and attract foreign direct investments (FDI) in the sector. It should include the word “facilitate the sale” to encompass the business models of the companies which don’t stock and sell medicines, but only facilitate the sale via sellers (market places). It will be important to differentiate them from e-pharmacy retailers or wholesalers.
The Union Health Ministry recently released draft rules for e-pharmacies to regulate online sale of medicines across the country and provide patients the accessibility to genuine drugs from authentic online portals.
It defined e-pharmacy as business of distribution or sale, stock, exhibit or offer for sale of drugs through a web portal or any other electronic mode
IAMAI requested withholding of regulations until the Sri Krishna Committee report is finalised.
“Issues relating to sharing of Personal Information is presently being discussed under the Personal Data Protection Bill 2018 by the Justice Sri Krishna Committee and all regulations pertaining to sharing of personal data of customers will be governed by that law,” IAMAI added.
The e-pharmacy draft states that e-pharmacy registration holder is prohibited from disclosing information received from the customer by way of prescription or in any other manner for any other purposes nor shall same be disclosed to any other person. The draft says that the registration holder shall be duty bound to provide such information to the Central or state government.
While the draft rules clearly mention a central licensing authority, as far as e-pharmacies are concerned, there is also Rule 67T (3), which talks about the power of the state governments to cancel registrations.
The confusion lies around the question of where this power is coming from. Periodic inspection and jurisdiction of multiple authorities will hamper ease of doing business. In many cases, the service providers are mere technology platform providers operating under the marketplace model and not actually engaged in the act of selling medicines.