Mumbai: In what could be a big disappointment for e-pharmacies and a huge inconvenience to patients, the Madras high court barred online sale of medicines from December 20, while directing the government to expedite regulations for e-pharmacies. The court in its final order asked the government to notify regulations by January 31, 2019, after which stakeholders will have to obtain licences within a period of two months. Representatives of online pharmacies said they are planning to appeal against the order soon.
The government is yet to come out with a notification amending the Drugs and Cosmetics Act, which will regulate online pharmacies. Recently, the expert committee under the health ministry, Drugs Technical Advisory Board (DTAB), approved the draft regulations for sale of online drugs by e-pharmacies. Earlier, the Delhi high court and Madras high court had passed interim orders stopping the sale of online drugs.
Though the draft to amend the Drugs and Cosmetics Act was issued in August, the final guidelines — after taking into account comments from stakeholders — was to follow through a notification. As on date, there are no proper rules or regulations for online trading of medicines, the judgment, a copy of which was available with TOI, said.
The draft rules reportedly mandate e-pharmacies to register with the drug regulator — Central Drugs Standard Control Organisation — and the central licensing authority. Also, e-pharmacies would only require a single licence to operate in the country. Though several such online platforms have mushroomed over the last few years, the major ones include 1mg, Practo, Netmeds, MedLife and Pharmeasy.
1mg co-founder of e-pharmacy Prashant Tandon said, “The legal process will take its course and we are confident the court will understand the distinction between fully compliant players like members of DHP (digital health platform) vis-a-vis the ones that do not comply, and should be stopped.”
Rajiv Gulati, promoter of mChemist, said, “We will fully comply with the court order. We are confident the government will immediately bring the gazette to mitigate suffering to the old, economically weaker and remote patients, since millions of such patients depend upon e-pharmacies for their regular supply of medicines.”
“The central government had already been given a longer rope by the order of the division bench, which was passed as early as on December 20, 2016. Though around two years have passed from the date of the said judgment, the rules are still at the draft stage,” the order said.
The order says other countries like the US, which has new laws in place, also finds the enforcement of online pharmacies, a challenge. While the pros and cons of the online pharmacy is debated, the stakeholders and the central and state governments are aware of the need for a cohesive system of regulation to be notified regulating online medicines.
