API Holdings, the parent of PharmEasy, has sought the Union health minister’s intervention for quick notification of the draft e-pharmacy rules to remove regulatory uncertainty regarding their existence after the Drug Controller General of India (DCGI) issued show-cause notices to these platforms over online sale of drugs citing violation of norms.
“We seek your support towards the quick notification of the draft e-pharmacy rules and the New Drugs, Medical Devices and Cosmetics Bill 2022 to remove any uncertainty and to harmonise all the existing regulations under which the e-pharmacy is already compliant,” the letter said.
The DCGI had issued show cause notices to about 20 such platforms in February.
“Multiple e-pharmacy players have received show cause notice from DCGI accusing them of violation of the provisions of Drug and Cosmetic Act and rules. Since the said Act is not applicable to e-pharmacies the question of violation of provisions is moot,” the letter said.
The government has proposed a draft legislation on multiple occasions, but it has yet to frame one.
In 2018 too, the health ministry had released a draft notification regulating e-pharmacies that barred the selling of medicines without registration. It banned the sale of narcotics, psychotropic drugs and tranquillisers by online pharmacies. But the rules could never be finalised.
In March this year, the department-related parliamentary committee on commerce urged the ministry of health and family welfare to notify the draft e-pharmacy rules. It said it was “appalled” that the rules had not been finalised till date.
The committee, headed by Congress leader Abhishek Manu Singhvi, said while tabling the report on ‘Promotion and Regulation of E-Commerce in India’ that undue delay in adopting a definitive regulatory framework results in uncertainty, which is not conducive for the fast-paced digital markets. It recommended that the draft e-pharmacy rules be finalised and implemented without further delay.Retail chemist organisations have been protesting the sale of online medicines through e-pharmacies as they are not currently regulated.
Calling it a “strong pillar” to significantly improve access to affordable medicines, API Holdings said the sector provides “quality” and “affordable” medicines to about 100 million families across the country and employment to about 150,000 skilled professionals.
“The negative narrative questioning the legitimacy of the e-pharmacy model has created chaos among the 1.5 lakh professionals employed by e-pharmacies,” said API Holdings.