Where are the guidelines on e-pharma, Patna HC asks government

MUMBAI: The Patna High Court has questioned the delay in finalising the amendments to the Drugs and Cosmetics Rules, 1945, by the Ministry of Health and Family Welfare that would set the conditions and rules for e-pharma companies to conduct business in the country.

In its order of July 31, the court said the draft rules have not been finalised almost a year after their publication and sought the reason for the delay from the government.

“We thus direct the secretary, Ministry of Health and Family Welfare to inform this court as to why the draft rules remains in the draft situation and what are the impediments in giving it a final shape.” ET has reviewed the order.

The case will be heard next on August 19. Mails to the ministry seeking comments were not answered.

E-pharma companies have been waiting for the guidelines to take shape in an uncertain regulatory climate roiled by conflicting court orders on online retailing of drugs in the last year. In December 2018, the Madras High Court issued a notice banning online sale of medicines before suspending the ban later.

The Delhi Court issued a similar ban order in December. In the ongoing case, e-pharmacies have alluded to food-delivery startup Swiggy arguing that just as that company does not require a restaurant licence to deliver food, so, similarly, e-pharmacies should not require a licence to deliver drugs to those who buy it online. The next date of hearing is on September 24.

The uncertain regulatory climate has led to a consolidation in the e-pharma space with larger companies buying out smaller rivals and a drop in investments for seed-stage pharma startups. Seed and early-stage companies secured $30 million in 2018 compared to $75.94 million in 2017, data from startup data tracking platform Tracxn showed. However, big players did not face funding pressures and have expanded with large foreign equity funded rounds.