On February 10, the Drug Controller General of India (DCGI) issued a show cause notice to 20 e-pharmacies in the nation. The drug regulator has requested internet pharmacies to explain why they should not be prosecuted for selling and distributing medications in violation of the Drugs and Cosmetics Act of 1940.
In a notification received by Moneycontrol, VG Somani, the DCGI, informed e-pharmacies that there are multiple lawsuits in several courts asking restriction of online medication sales.
According to the drug regulator’s notice, the sale, stock, exhibit, or offer for sale or distribution of drugs through online, internet, or other electronic platforms without a licence has the potential to impact drug quality and pose a risk to public health due to potential drug misuse through self-medication and indiscriminate use of the drugs.
“In view of above, you are hereby asked to show cause within 02 days from the date of issue of this notice, why action shall not be taken against you for sale, or stock or exhibit or offer for sale or distribution of drugs in contravention of the provisions of the Drugs and Cosmetics Act, 1940 and Rules made thereunder,” the notice of DCGI to e-pharmacies said.
Somani stated that if the corporation does not respond to the notification, it would be assumed that they have nothing to say in this case and that appropriate action will be taken against them without further notice.
The Supreme Court cited an order of the Delhi High Court in the case of Dr. Zaheer Ahmed vs. Union of India and others.
The notice copy to e-pharmacies mentions the excerpt from order saying “Respondents are injuncted from online sale of medicines without licence and the respondents are directed to ensure that the same is prohibited forthwith until further orders.”
According to the DGCI, despite the apex regulator’s directives to comply with the Delhi High Court’s ruling, e-pharmacies were found to be selling medications online without a licence.
Somani stated in the notice that he has received several submissions raising concerns about the sale of pharmaceuticals via online, internet, or other electronic platforms, including different mobile applications, in violation of the requirements of the Drugs and Cosmetics Act, 1940 and Rules thereunder.
“The Rule 64 of the Drugs Rules, 1945, prescribes conditions to be satisfied before a sale license is granted; while Rule 65 prescribes the conditions of the license to be complied by the licensee,” the notice copy said.
According to DCGI’s letter, if the medicine is to be supplied or stocked for sale in more than one location, a second application for licence must be presented to the licencing authority.
“Thus, for sale, or stock or exhibit or offer for sale or distribute any drug, a license is required to be obtained from the concerned State Licensing Authority and conditions of license are required to be complied by the licensee,” it added.
