As the characteristics of the medical device industry are different from the pharmaceutical industry, the medical device industry has sought a separate marketing practices code for the medical devices industry.
The medical devices industry associations raised this issue at a review meeting held by the Department of Pharmaceuticals (DoP) on August 21, 2020, to review implementation of the Uniform Code of Pharmaceutical Marketing Practices (UCPMP). The meeting, held through video conferencing, was chaired by DoP secretary Dr P D Vaghela.
“The characteristics of the medical device industry are somewhat different from the pharma industry and though the associations have requested in earlier meetings to have a separate code for the medical devices industry, AiMeD is in agreement with the government to start with pharma defined code first but with some changes. Innovative and high-end medical devices such as robotics require proper training to impart skills to users unlike drugs. However, training can be given ethically with no lavish conferences and free travel to exotic tourist destinations,” stated Rajiv Nath, forum coordinator , Association of Indian Medical Device Industry (AiMeD) further adding that AiMeD has uploaded UCPMP on its website and formed the ethics committee as well as held meetings, invited suggestions and complaints from its members.
“Ethical marketing is being a challenge in India of medical devices if manufacturers and importers use artificially inflated high maximum retail price (MRP) high trade margins to induce hospitals and retailers to push their products. We have been seeking that MRP should not be over four to five times of import landed price or ex factory price (on which GST is charged initially) instead of prevailing MRP that go up to 20 times,” Nath further added.
The orthopaedic implant Industry is challenged by the co existence of hundreds unlicensed manufacturers of implants that are allowed to market their unlicensed implant without regulatory approval which creates an unethical and unfair marketplace, stated Anu Dureja of Siora Surgicals and AiMeD member.
“Exorbitantly high demands for sponsorships by doctors, hospitals has been challenging for us” stated Kanwar Sehgal of Endomed Technologies. “These huge expenses can’t be matched by the small and midsize segment of the medical devices industry and denies access of affordable Indian products to Indian patients,” he explained.
The DoP secretary had asked all the associations including medical devices to implement UCPMP. Secretary (DoP) showed his displeasure at the status of implementation of UCPMP and exhorted all associations to implement the code without exception. He mentioned that suggestions can be discussed in separate meetings under JS (Policy) to be called next week for medical Devices separately. He also asked the associations to quote exact provisions of laws of other countries as precedence and reference while giving suggestions in respect of UCPMP.
Despite government mandate on UCPMP and as envisaged by DoP, details have not been uploaded related to the Ethics Committee for Pharma Marketing Practices (ECPMP) and Apex Ethics Committee for Pharmaceuticals Marketing Practices (AECPMP) of all the associations along with contact number and procedure of filing complaints on the website of DoP.
To review the implementation of the voluntary UCPMP, all the associations (Pharmaceuticals and medical devices) are requested to provide the details of their Ethics Committee for Pharma Marketing Practices (ECPMP) and Apex Ethics Committee for Pharmaceuticals Marketing Practices (AECPMP) along with contact numbers and procedure of filing complaint so that the same can be uploaded on the website of DoP.
A meeting to review the implementation of UCPMP was held under the chairmanship of Secretary (DoP) on February 17, 2020. Secretary, DoP enquired how many associations have uploaded the UCPMP on their website and have formed the two Committees.
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