Purchase Genuine Medicines Online

India is a step closer to putting in place laws to ensure that patients are able to purchase genuine medicines from authentic online pharmacies, with a new draft of rules circulated among states for their opinion. The Union health ministry has come out with a draft proposal to amend Drugs and Cosmetics Rules, 1945 to insert Part VIB to facilitate sale of drugs by e-pharmacy. The draft released by the ministry on April 18, 2018 proposes to insert Part VIB in D&C Rules after Rule 67H and before Part VII. 

The much awaited draft for e-pharmacies eases conditions that would have made it difficult for them to operate in this space, but also keeps enforceable penal provisions in case of any violations, according to persons aware of the latest draft.  

For instance, the latest draft, which has been viewed a copy of, removes a condition earlier proposed that would have required online pharmacies to apply for licences in every State they would sell medicines in. 

Now, e-pharmacies would only have to seek one licence from the Drug Controller General of India, the country's apex drug regulator and central licencing authority.  

E-pharmacy shall apply for the grant of registration to the Central Licensing Authority in Form 18AA through the online portal of the Central government along with a fee of Rs. 50,000. A registration issued to e-pharmacy in Form 21AA shall remain valid for a period of three years. The premises from where the e-pharmacy business is conducted shall be inspected in every two years by a team of officers authorised by the Central Licensing Authority along with the experts. Even while licencing requirements have been relaxed, e-pharmacies will be closely watched and could face tough penalties in case they violate regulations, according to the draft. This is to keep a stringent watch on the online businesses so that they operate "without any violation.

It has also done away with a proposal to create a central server through which all online prescriptions would be routed to individual e-pharmacy portals. This system was earlier proposed as a measure to curb potential abuse of prescription medicines by ensuring that a patient does not continue to use the same prescription at different e-pharmacies, a senior government official had earlier said. 

According to the latest draft, e-pharmacies would only be able to sell medicines through premises with valid retail licences. 

The retailer dispensing the medicines would have to keep records of e-prescriptions of patients. For monitoring of e-pharmacy, the draft says the e-pharmacy shall maintain and update, from time to time, the information regarding the drugs availability, types of drugs offered for sale, supply channels or vendor lists, details of physicists, registered medical practitioner, (if any) and any other requirements of the Drugs and Cosmetics Rules on the e-pharmacy portal.

The Central Licensing Authority and the State Licensing Authority shall monitor the data or information as referred to in sub-rule (1), periodically to ensure compliance with the provisions of the Drugs and Cosmetics Act, 1940 and Rules thereunder.

In case of violations, the regulator can suspend and even cancel registration licences of e-pharmacies after giving them an opportunity to show cause as to why such an order should not be passed against them, according to it. 

The proposed regulation has also maintained measures proposed earlier to ensure that patient data is not misused by third parties or sent out of the country. 

"Details of the patient shall be kept confidential and not be disclosed to any person other than the Central Licencing Authority," states the latest draft. This information will only be shared with the authority for "public health purposes". 

E-pharmacies will also require a facility for customer support which will operate for at least 12 hours every day of the week, the draft proposes. 

In the event of suspicion of supply of a not of standard quality or adulterated or misbranded or spurious drug through e-pharmacy to any customer, that customer may file a complaint in writing to the concerned State Drugs Controller, by whatever name called, in that State. Besides this, the customer has a right to seek relief under the Consumer Protection Act, 1985 and rules made thereunder.

Online pharmacies will be regulated under the Drugs and Cosmetics Rules, 1945 and would also have to abide by regulations like the Information Technology Act, 2000 and the Narcotic Drugs and Psychotropic Substances Act, 1985. No e-pharmacy shall advertise any drug on radio or television or internet or print or any other media for any purpose.