The Department of Pharmaceuticals has released Draft Uniform Code for Medical Device Marketing Practices 2022 (“Draft Code”).
The Draft Code aims to regulate on a voluntary basis, marketing practices in the medical device industry which is currently being voluntarily regulated by the Uniform Code for Pharmaceuticals Marketing Practices, 2014 (“UCPMP”).
The Draft Code is intended to be a voluntary code and its implementation is proposed to be reviewed after a period of six months from the date of its issue. The Draft Code states that if it is found that it has not been implemented effectively by the Medical Device Associations / Companies, the Government may consider making it a statutory code.
The Draft Code is open for stakeholder comments until 15th April 2022.
Some key features of the Draft Code are as follows:
- The Draft Code prohibits a medical device from being promoted prior to receipt of the product registration.
- Product information about medical devices and any claims thereto must be up-to-date, verifiable, and accurately reflect current knowledge. Claims for the usefulness of a Medical Device must be based on evaluation of the available and published evidence.
- Comparisons of medical devices are to be factual, fair and capable of substantiation. Any promotional material must not be designed to disguise the real nature of a medical device.
- The names or photographs of Health Care Professionals (“HCPs”) must not be used in Promotional Material.
- Norms of ethical conduct are prescribed for medical representatives.
- Provision of gifts, pecuniary benefits etc., to persons qualified to use, prescribe, or supply medical devices is prohibited.
- Guidelines are prescribed for HCPs and medical device companies to collaborate on training programmes to advance medical technology.
- Procedure for lodging complaints is provided for.
A voluntary code for marketing practices in the medical device industry is likely to serve as a guiding force to the medical device industry, particularly in light of certain notified medical devices being regulated as Drugs under the Drugs and Cosmetics Act, 1940.
Unlike the UCPMP which is a voluntary code for the “Indian Pharmaceutical Industry”, the Draft Code has been stated to be a voluntary code for the “Medical Device Industry”, recognizing that the types of entities involved in Medical Device marketing are not restricted to those in the pharmaceutical industry.
Further, for guidelines pertaining to Gifts, the Draft Code departs from the UCPMP to the extent that unlike the UCPMP, the Draft Code permits companies to occasionally provide modest, appropriate educational items to HCPs that benefit patients or serve a genuine educational function for HCPs. Companies may also occasionally provide modest, appropriate brand recall items/brand reminders, which are customary business courtesies and are reasonable in value (not exceeding Rs. 1000) and frequency.
However, in the light of the fact that the Ministry of Health and Family Welfare has specifically included certain types of software as medical devices, the Draft Code still appears primarily worded in respect of “hardware” medical devices. Further clarity on marketing practices for “software” medical devices, particularly where they may be marketed in combination with generic (i.e., non-medical device) hardware may be needed.
Public Notice – Draft Uniform Code for Medical Devices Marketing Practices, 2022 https://pharmaceuticals.gov.in/sites/default/files/DoP_Public%20Notice_Dated%2016032022.pdf