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Online Pharma Sale Cannot be Regulated till Center Makes Rules: TN Regulator

In the latest development in the litigation against online pharmacy sales in the country, the State Food Safety and Drug Administration Department of Tamil Nadu has submitted before the court that the online sale of medicines cannot be regulated until rules governing it are framed. The counter affidavit was filed by the Director of Drugs Control in a petition filed by the Tamil Nadu Chemists and Druggists Association (TNCDA) seeking an order against online sales of medicines through e-pharmacy websites, since it is not permitted under the prevailing Drugs and Cosmetics Act and the granting of permission for such activities is in progress through a draft rule. The state administration submitted that blocking the links of the online pharmacies was not under the purview of the provisions of the Drugs and Cosmetics Act. It added that the state government did not have any role in any addition or deletion in and amendment to the concerned Act and Rules.

“Therefore, unless and until there are any rules governing the same, online sale cannot be regulated. What cannot be regulated cannot be permitted. The Act recognizes and permits only certain manner of sale/vending particularly retail,” said the counter, adding that the writ petition was not maintainable at present and was liable to be dismissed. On October 31, the court issued an interim order restricting online sale of medicines without a license and directed the Government of India or competent authority to stall such online sales. Six online pharmacy firms — 1MG Technologies, Digital Health Platforms, Netmeds Market Place, 91 Streets Media Technologies, Medline International and Practo Technologies — have been impleded in the matter and sought the court to clarify that the ban was only on unauthorized sellers. They argued that they sell only based on prescriptions and through registered pharmacists. The online aggregators said that they can give an undertaking that they are selling only from licensed pharmacies. Companies such as Netmeds argued that they already have a license to sell medicines and they should not be affected because of the order.

On Monday, the Chennai-based online pharmacy TNMEDS and a regional pharmacists’ organisation were also impleded in the matter. The court adjourned the hearing to December 5, with the central government yet to file its counter affidavit on the matter. TNCDA has been arguing that the prevailing regulation has no provisions for selling medicines through the online channel and draft rules for the same are still under consideration, which shows that the current online sales of medicines are not legal. From a market size of USD 12.6 billion in 2009, the Indian pharmaceutical market is expected to grow to USD 55 billion by 2020, with the potential to reach USD 70 billion in an aggressive growth scenario. estimates that e-pharmacy’s market potential is worth over a billion dollars, with global and domestic industry giants such as Amazon and Flipkart, along with more than 30 start-ups, trying to grab the pie. – Business Standard