Delhi HC Seeks Progress Report From Centre Over Delay In Issuing E-Pharmacy Rules
New Delhi, 8 Feb 2019: In the wake of an inordinate delay in notifying the final e-pharmacy regulations, the Delhi High Court has directed the Central government to submit a status report on the draft rules at the earliest on a petition filed by a senior dermatologist seeking a ban on online sale of drugs. The court, in a hearing on February 6, also asked online pharmacy players to submit their counter affidavit within the next four weeks.
India currently does not have a regulatory mechanism for online drug stores and the laws governing the brick-and-mortar pharmacy business are applicable to e-pharmacies as well. The Drugs and Cosmetics Act does not distinguish between conventional and online sale of drugs. Though the health ministry came out with an extensive set of draft regulations in September last year to give patients access to safe drugs from genuine online platforms, the final notification is yet to be issued. The Central Drugs Standard Control Organisation has already weighed suggestions from various industry stakeholders on the draft. The delay in issuing the final rules is putting numerous e-pharmacy companies in jeopardy.
In his petition, Delhi-based dermatologist Dr Zaheer Ahmed states that online sale of medicines is not permitted under the D&C Act of 1940 and the Pharmacy Act of 1948. The petition contended that e-pharmacies were selling drugs online despite the Drug Controller General of India’s directive to the state drug controllers “to put a strict vigil on online sale of medicines in violation of the Drugs and Cosmetics Act and Rules thereunder, to protect the interest of public health”.
“The next hearing in the case is scheduled for May 9. The interim order that stayed online medicine sales through unlicensed e-pharmacies would remain in force till then,” an industry representative said.
Recently, the Madras High Court, while suspending an interim ban on online medicine sales, had directed the Central government to notify rules regulating online medicine sales by January 31. E-pharmacies were directed to comply with the notified rules thereafter. The court also observed that shutting e-pharmacies would be detrimental to the industry.
The Tamil Nadu Chemists and Druggists Association (TNCDA), that moved the court against online drug sales, sticks to its stance that the business is illegal. “The present Drugs and Cosmetics Rules have no provisions for selling medicine through the online route. Let the government notify new norms,” says TNCDA President K Manoharan.
Many e-pharmacy groups cite the observation of the Madras High Court to defend their case, stressing that they are only intermediaries in the supply chain. “Online sale is going on for quite some time. If all of a sudden it is stopped till the amendments are notified, it would definitely create grave hardship, inconvenience and health issues to the patients/persons concerned, who order medicines through online platforms,” the court had noted.
According to India e-pharmacy market Opportunity Outlook 2024 report, India currently has over 850,000 independent pharmacy retail stores which are able to meet only 60 per cent of total domestic demand. These traditional retail pharmacies are responsible for 99 per cent of the pharmaceutical sales annually, with online pharmacy contributing to only 1 per cent of the total sales. Pharmabiz