Our patient at risk from unauthorized, unapproved, illegally imported fake “generic medicines”

Introduction: We came across patients inquiring with oncologists about cheap copy medicines. These were of recently licensedinnovator drugs that should have been available from original company holding their patents. In fact these copy medicines weremanufactured in our neighboring countries and made available in India. We investigated further and this manuscript puts together thestartling information that we were able to find regarding the thriving grey market for fake generic medicines.

Standard operating procedure for audio visual recording of informed consent: An initiative to facilitate regulatory compliance.

The office of the Drugs Controller General (India) vide order dated 19th November 2013 has made audio visual (AV) recording of the informed consent mandatory for the conduct of all clinical trials in India. We therefore developed a standard operating procedure (SOP) to ensure that this is performed in compliance with the regulatory requirements, internationally accepted ethical standards and that the recording is stored as well as archived in an appropriate manner. The SOP was developed keeping in mind all relevant orders, regulations, laws and guidelines and have been made available online. Since, we are faced with unique legal and regulatory requirements that are unprecedented globally, this SOP will allow the AV recording of the informed consent to be performed, archived and retrieved to demonstrate ethical, legal and regulatory compliance. We also compared this to the draft guidelines for AV recording dated 9th January 2014 developed by Central Drugs Standard Control Organization. Our future efforts will include regular testing, feedback and update of the SOP.

ICON 2013: Practical consensus recommendations for hormone receptor-positive Her2-negative advanced or metastatic breast cancer.

The management of hormone receptor‑positive Her2‑negative breast cancer patients with advanced or metastatic disease is a common problem in India and other countries in this region. This expert group used data from published literature, practical experience, and opinion of a large group of academic oncologists, to arrive at practical consensus recommendations for use by the community oncologists.