CDSCO which has constituted the sub-committee to scrutinise the concerns of permitting the online pharmacy business model under the purview of the Drugs and Cosmetic Rules 1945 will now meet on September 7, 2015 at Mumbai. Following the 48th meeting of the Drugs Consultative Committee held on July 24, 2015, the formation of a dedicated sub-committee came into being.
The sub-committee has been intimated by the CDSCO that within the next three months, it will need to furnish its report about the importance of online pharmacy in the current context of advancements in information technology and the internet along with a set of norms that would enable the players in the space to stay complaint.
The subcommittee has Dr. Harshadeep Kamble, commissioner of FDA Maharashtra who would chair the deliberations supported by Raghurama Bhandary, Karnataka drugs controller, H Mahapatra, Odhisha drugs controller Atul Kumar Nasa, assistant drugs controller, CDCSO, Salim A Velijee, director, FDA Goa Pankaj Agarwal from Madhya Pradesh State Licensing Authority and Dr. Eshwara Reddy, joint drugs controller, CDSCO.
Karnataka drugs controller Raghurama Bhandary confirmed to Pharmabiz that the first meeting would be held on September 7.
The current drug regulations do not permit online pharmacy services and there is an urgent need to put in rules for the same. Since the DCGI office is aware of this disturbing trend, it is looking to issue a set of norms for online pharmacies and hence formed a dedicated subcommittee to deliberate on the same.
Now the sub-committee will meet to study and endorse changes that would be needed under the Drugs & Cosmetic Rules 1945 to make certain that the only authentic and genuine sale of drugs are permitted via online pharmacy platforms with maximum caution to protect the patient with safe and high quality medicine access.
Besides the committee would assess global regulations on e-pharmacies and the prevailing practices and scope for violations. These include the US FDA’s Verified Internet Pharmacy Practice and European Union’s norm on common, EU-wide logo to identify legal online pharmacies. Further, it would also view the apprehensions and threats involved in the sale of drugs over internet to the consumers.
Even at the last 48th meeting of the Drugs Consultative Committee in New Delhi, the issue of clandestine sale of medicines via internet by certain web portals was deliberated extensively and it was soon after this that DCGI recommended the formation of a sub-committee to look into the details of the sale of drugs via internet and suggest the ways and means of regulating such sales via the internet under the provisions of the D&C Act, according to sources.