In the latest developments, the Drugs Controller General of India (DCGI) has issued a directive to all states and Union territories. This directive prohibits the sale of medicines through unlicensed online platforms as per an order from the Delhi High Court. This move is a derivation from the Zaheer Ahmed case in 2018 where the court ordered that the online sale of medicines should be halted until appropriate rules for e-pharmacies are constructed and enforced. With the growth of online prescription medicine sales being fairly new in India, the legislation to regulate this sector is still under construction.
Government’s Initiative: Drafting the E-Pharmacy Rules
The government is currently working on draft rules for e-pharmacies, which are being assessed by a group of ministers (GoM) led by the defence minister. The need for such rules was recognized after allegations arose about the breach of the Drugs and Cosmetics (D&C) Act, 1940 by e-pharmacies. According to this Act and the D&C Rules, 1945, the sale of counterfeit drugs is a punishable offence. State Licensing Authorities have been entrusted to enact action concerning this matter.
Persistent Online Sales Despite Prohibitions
In spite of these regulations, e-pharmacies managed to continue with their online sales due to a stay granted by the Madras High Court in January 2019. Earlier, in December 2018, a single-judge Bench of the same court ordered traders to suspend their online drug business until rules were officially notified by the Central government.
E-Pharmacies’ Stance and Justification
E-pharmacies argue that their business model abides by the Information Technology (IT) Act, 2000 under the concept of intermediaries. They claim that their pharmacy retail operations comply with the Drugs and Cosmetics Act.
The Drugs and Cosmetics Act, 1940
The primary role of the Drugs and Cosmetics Act, 1940 is to regulate the import, manufacturing, and distribution of drugs in India. The Act aims to certify that the drugs and cosmetics sold in India are safe, effective, and meet the required safety standards and parameters.
Proposed Draft Rules for E-Pharmacies
| Rule | Description |
|---|---|
| Registration | E-pharmacies intending to sell online must register with the Central Drugs Standard Control Organization (CDSCO). |
| Verification | E-pharmacies should verify and keep record of the details of patients and doctors. |
| Advertising | No e-pharmacy shall advertise any drug on radio or television or the Internet or print or any other media for any purpose. |
| Invoice | The supply of any drug shall be made against a cash or credit memo generated through the e-pharmacy portal. |
Advantages and Challenges of E-Pharmacies Sector
E-pharmacies have their set of advantages including discount offers, easy delivery option at one’s doorstep and transparency in service delays or non-availability of certain drugs. Customers have the ease of comparing and selecting their medicines. However, there are disadvantages as well. This rapidly growing sector poses a significant threat to the business of traditional pharmacies. Close to a million chemists, distributors, and their employees might be affected due to their advancement. Additionally, monitoring fake and illegal pharmacies could be a challenge and would require cyber experts to tackle such cases. Other concerns include the potential for drug abuse with one prescription being uploaded on multiple e-pharmacy sites, which can lead to misuse of drugs and an increase in drug addictions, particularly among the youth.
