Medical device companies may get code respite for 6 months
The Times of India , Jan 02, 2017
The Department of Pharmaceuticals (DoP), which is drafting a separate marketing code for medical device manufacturers, might give the companies six months for voluntary implementation of the code before making it statutory. Medical device manufacturers were already a part of the uniform code of pharmaceutical marketing practices (UCPMP) announced on January 1, 2015, which was to be made statutory after six months but the voluntary code has been extended indefinitely.
Following the implementation of the UCPMP, on March 9, 2015, the DoP issued a clarification that it "was also applicable to the medical devices industry".
Following this, the Association of Indian Medical Device Industry (AIMED) wrote to the DoP saying it was willing to follow the code devices. But in 2016, DoP engaged the National Health Systems Resource Centre (NHSRC), the Union health ministry's technical support institution, to draw up a code suitable for India. The first meeting to discuss the 'uniform code for medical device marketing practices' was held by the DoP with the industry on August 24, 2016, followed by another on November 5.
Even as a separate code for devices was being finalised, the DoP's last notification on August 30, indefinitely extending the UCPMP, still included devices and sought details from both the pharmaceutical and the devices industry on steps taken by them to implement the code to prevent unethical and illegal practices.
The DoP meetings included the then NHSRC director Jitendra Sharma, and representatives from FICCI, CII, ASSOCHAM and the American Chamber of Commerce in India. The device industry demanded that the code be voluntary for the first six months. In the meetings, several clauses in the original draft were deleted or put off for "review after six months". For instance, the draft stated that even third parties working for device companies, but asked for medical devices to be made a separate product category. The letter also stated that if there were practical challenges in complying with the code, the industry would seek minor amendments. AIMED asked that the devices industry be given a trial period till December 31, 2015.
However, in July, the Federation of Indian Chambers of Commerce and Industry (FICCI) asked for a separate code altogether for the device industry due to the "unique nature of medical technology as opposed to pharmaceutical industry".
It added that since users (physicians, nurses, technologists etc.) needed to be trained in the use of devices, it was important for the manufacturer to be engaged in educational activities. It suggested that India could adopt the US or Japanese code.
Till November 2015, the DoP continued with the UCPMP for both drugs and when engaged in activities covered by the code, would be expected to have a working knowledge of it. This was meant to tackle bribing and illegal marketing done by dealers on behalf of the device companies, a common practice in India. However, this clause has been deleted. Malini Aisola of All India Drug Action Network said, "Civil society groups like us and the Jan Swasthya Abhiyan have not been invited to any of the meetings though we have been involved in the issue of devices and their marketing. How can DoP make a code only in consultation with the industry?"
"This ethical code is urgently needed as incorrect practices of aggressive marketing by some pharmaceutical companies are also beginning to be followed for medical devices by some multinationals. This is putting unhealthy pressure on domestic manufacturers to match such practices, which include sponsoring of exhibitions and conferences at huge costs to please the heads of departments and hospital CEOs who make the decisions on device purchases," said Rajiv Nath of AIMED. Yet, the implementation of the code remains stalled.