Medical device makers will no longer be able to bribe doctors for samples, gifts or in the name of recreational activities such as theatre, spas, live comedy or music, sports events, golf, skiing, cruises and trips. The Narendra Modi government has come up with a code to stop this. Medical devices are considered similar to drugs. There is already a code for the pharmaceutical sector and a separate draft has been prepared for the medical device sector. The reason for this is that the government wants to regulate it as a separate industry in the future.
While the code will be “voluntary” for the industry, stressing on self-regulation, the government has warned that it could be made “statutory” if not implemented well. The Department of Pharmaceuticals, under the Ministry of Chemicals and Fertilizers, has released a draft code for marketing of medical devices. Feedback from industry representatives has been sought in this regard by April 15.
According to the draft, the medical device sector is an “important pillar” in the healthcare system and will help achieve the key objective of the National Health Policy 2017 in terms of provision of good quality, affordable and comprehensive healthcare to all citizens.
Based on the request of the MedTech industry to have a separate Uniform Code and on realizing such needs, the draft states that “the Department in consultation with the industry has prepared a separate Uniform Code for Medical Devices Marketing Practice (UCMDMP).”
The 16-page draft states that the UCMDMP draft is a voluntary code and its implementation will be reviewed after a period of six months from the date of its issue. If it is found that it has not been implemented effectively by medical device associations and companies, the government may consider making it a statutory code. In case of any wrongdoing, the Managing Director or Chief Executive Officer or authorized person of the Company will be held responsible for “non-compliance of the Code”.