LSW Roundtable 4th Edition with Dr. R K Vats, Addl. Secretary, Ministry of Health & Family Welfare, and Dr. S Eswara Reddy, DCGI, April 5, 2018, The Orchid Hotel, Mumbai
ACTION POINTS FROM DIALOGUE WITH DR. R. K. VATS, ADDITIONAL SECRETARY & DIRECTOR GENERAL, CGHS AND DR. ESWARA REDDY, DRUG CONTROLLER GENERAL (INDIA) (DCGI)
Summary on Devices
Medical devices should not be treated as drugs:
Members are willing to subject themselves to a mandatory promotion code. DOP (Dept. of Pharmaceuticals) should ensure that there is level playing field in terms of ethical standards of promotion.
Medical device companies have unique requirements. They should not be governed by UCPMP as it has a deep pharma focus.
It is difficult for Members to request HCPs to give a written request for samples. Such a request is highly impractical.
Members should be allowed to leave brand reminders within pre-determined value cap. This is in-line with global practices.
Hon’ble Secretary took note of the Members concerns and commented the following:
The UCPMP will continue to be a voluntary code until notified. There are challenges with regards to enforcement of UCPMP. Hence, it is not easy to make UCPMP mandatory.
Medical device companies should prepare and present a draft code for medical devices promotion.
Since UCPMP is a voluntary code, so compliance with such requirement is left upto the members.
Members stressed that with the advance of science a lot of diseases which were incurable sometime ago are now curable. Further, the risk of irrational self-medication which arises as a result of advertisement of pharmaceuticals does not arise upon advertisement of medical devices. Therefore medical devices should be kept outside the purview of advertisement law.
Members expressed concern that notified medical devices are required by law to limit their shelf life to five years whereas scientific evidence exists to increase shelf life of certain notified medical devices can be extended to 10 years.
Hon’ble Secretary noted the concerns of the Members and commented at his closing remarks that Separate consultation for UCPMP for medical device should take place
Participants
Pharma (Drugs):
Sanjeev Navangul, Managing Director, JNJ
Dr. Shailesh Ayyangar, Managing Direct, Sanofi
Yasmin Shenoy, Sr. Director, Regulatory, Sanofi
Bhavesh Kotak, Exec. Vice President, Medical, GSK
Sukanya Choudhury, Vice President-Regulatory Affairs, South Asia, GSK
