Manufacturers must use new brand names
A final set of rules is expected this year on how e-pharmacies should be properly regulated, according to Nishith Desai Associates (NDA) which reviewed the industry in 2019.
“All in all, the progress made over the course of 2019 has paved the way for a very exciting 2020!” said the Mumbai headquartered global consultancy.
The government has also taken some laudatory steps by requiring manufacturers to use brand names for drugs that are not similar to other brand names or trade names of drugs already in existence as a condition for obtaining the manufacturing license, it noted.
Given all the collective developments that have taken place in 2019, 2020 should be filled exciting times for the pharma industry. In case you missed it, do also read our pharma round up covering updates from January to July here.
The Drug Controller General of India (DCGI) has issued an office letter on 28 November 2019 requiring all drug controllers to enforce an order passed by the Delhi High Court in December 2018 in the case of Zaheer Ahmed v. Union of India W.P.(C) 11711/2018 (Delhi HC Order) which prohibited the online sales of medicines without a valid license (Office Letter).
The Delhi HC Order is based on a previous order issued by the Madras High Court banning the online sales of medicine altogether. However, even though the Madras High Court Order was subsequently reversed in appeal, the Delhi HC Order continues to remain in force.
The Office Letter is the latest development in a series of events surrounding e-pharmacy regulation.
According to NDA, e-Pharmacies have been at the center of controversy in India since 2015, with regulators being asked to keep a strict watch on all players in the market until the expert committee, headed by ex-Maharashtra Food and Drug Commissioner Harshdeep Kamble examined the issues in the sector.
The committee had later submitted its recommendations to DCGI, India’s apex drug regulator, who had reportedly examined the report and forwarded his recommendations to the Ministry of Health and Family Welfare.
Subsequently, in August 2018, the Health Ministry released draft rules proposing to regulate e-pharmacies under the ambit of D&C Act (E-pharmacy Rules).
However, soon after the E-pharmacy Rules were published the aforementioned orders were passed by the Delhi High Court and Madras High Court.
The Office Letter appears to only be a continuation and reaffirmation of the current position i.e. online sale of medicines should not be done by pharmacies who are not licensed. fiinews.com