New Delhi : The central government has proposed to regulate online pharmacies, which has proliferated in recent times in India, through a fresh draft of the New Drugs, Medical Devices, and Cosmetics Bill, which has been released for discussions, according to people familiar with the matter.
The government may “regulate, restrict or prohibit the sale, stocking, exhibiting or offer for sale or distribution of any drug by online mode by notification,” the draft legislation said.
The government has been wanting to regulate e-pharmacies because these have been mushrooming across the country, offering deep discounts. Several retail chemist organisations have been protesting the sale of online medicines through e-pharmacies as they are not currently regulated.
In 2018, the health ministry released a draft notification regulating e-pharmacies that barred the selling of medicines without registration. It banned the sale of narcotics, psychotropic drugs and tranquilisers by online pharmacies. The ministry made amendments to the Drugs and Cosmetic Rules, 1945, to include e-pharmacies.
A consultative committee on e-pharmacies was formed in 2015, which after 86 deliberations submitted its report to Drug Controller General Of India in 2016.
The new Bill that will replace the existing Drugs and Cosmetics Act of 1940 also proposes stricter regulatory control of the central government over manufacturing of drugs through its central drugs standard control organisation. Currently, manufacturing licenses are issued by state drugs regulators.
The draft legislation was placed in the public domain in July last year for feedback. The health ministry and the Central Drugs Standard Control Organisation received several comments from stakeholders on the draft Bill, which was revised accordingly by the ministry and sent for inter ministerial consultations.
Conduct of clinical trials as per the updated guidelines has also found mention in the draft law. Currently, the conduct of clinical trials for new drugs and medical devices and the provisions for compensation for injury or death on account of participation in clinical trials, medical management of the trial participants, and regulation of the ethics committee, among others, are governed by the New Drugs and Clinical Trials Rules, 2019. Also, medical devices are treated as drugs and there is no separate definition for those.
The draft bill has a separate chapter on AYUSH drugs, which proposes to regulate the Sowa Rigpa and Homeopathy systems for the first time. The existing law regulates only Ayurveda, Unani and Siddha drugs and cosmetics.
