The Madras High Court has granted a stay on the order banning online sale of drugs till December 20 10:30 am following an appeal by online pharmacy players and directed the central government to notify regulations by January 31, 2019.
Justice Pushpa Sathyanarayana on December 17 issued a ban on online sale of drugs on a petition filed by the Tamil Nadu Chemists and Druggists Association (TNCDA).
The high court said till rules facilitating online sale of drugs are notified, the online traders are bound not to proceed with their online business in drugs and cosmetics.
Once proposed rules gets notified in the Gazette, the concerned stakeholders, namely, persons doing trade in online pharmacy have to obtain their licences, within a period of two months from the date of such notification, it added.
Upon e-pharmacy players’ request, the court has granted a stay on the order till December 20 10:30 am. The court had given online pharmacies four weeks to file a counter affidavit.
Meanwhile, the e-pharmacy players such as NetMeds, PharmEasy and Midlife are planning to file an appeal with the court against the ban order.
Confirming this, Tushar Kumar, CEO and founder of Medlife stated, “Keeping the interest of millions of our customers, most of whom are senior citizens and who are dependent on us, we will file an appeal with the court, specially since we are duly licensed at every premise from where we dispense.”
As of now, upon our request, the court has granted a stay on the order till December 20 10:30am and has directed the central government to notify the draft e-pharmacy guidelines in a time bound manner, he added.
The TNDCA in its petition had sought direction from the high court to the central and state governments to block the link of all such websites, who are carrying on online sale of Schedule H, H1 and Schedule X medicines in violation of Rules 65 and 97 of the Drugs and Cosmetics Rules, 1945, till the licences are granted to sell medicines through online.
The petitioner alleged that online pharmacists do not comply with the laws and are selling prescription drugs and controlled substances without valid prescription and they are also offering discounts for bulk purchases of prescription drugs.
In the counter affidavit filed by NetMeds, it is stated that they are not violating any law and they are meticulously following the mandatory provisions, i.e., Sections and Rules. It is specifically stated in the counter affidavit that they ensure compliance of Rules 65(4) (1), 65 (4)(3), 65(4)(4), 65(5)(1), 65(5)(3), 65(9)(a) and 65(9)(b) of the D and C Rules. It is also stated that as per Rule 65, Clause 11 of the D and C Rules, the person dispensing a prescription, containing a drug specified in Schedule H, shall comply with the requirements in addition to the other requirements of these D&C Rules viz., the prescription must not be dispensed for more than once, unless the prescriber has stated thereon that it may be dispensed more than once.
The High Court had earlier passed an interim injunction stopping online drug sales on the petition filed by TNCDA. However, the online firms received a reprieve later when the court clarified its order stating that the ban would be applicable to only unlicensed players.
In August, the government had come out with draft rules on sale of drugs by e-pharmacy with an aim to streamline online sale of drugs and ensure patient access to drugs from authenticate internet pharmacies. As per the draft, any person who intends to conduct the business of 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.
Under the draft rules which are yet to be formalised, e-pharmacies are required to register for a licence with the Drug Controller General of India. The licence is valid for three years. Also, the sale of tranquilisers, psychotropic drugs, narcotics, and habit-forming drugs has been banned online.
No e-pharmacy shall advertise any drug on radio or television or internet or print or any other media for any purpose. The premises from where the e-pharmacy business is conducted shall be inspected, every two years, by a team of officers authorised by the CDSCO, or the concerned State Licensing Authority. 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, stated the draft.
Last week the Delhi High Court had directed the Central and state governments to restrain the online sale of medicines by e-pharmacies across the country. The court issued the order on a public interest litigation filed by a Delhi-based dermatologist who objected to the sale of medicines on the internet.