The Department of Pharmaceuticals has released a draft uniform code for medical devices marketing practices.

Based on the request of the MedTech industry to have a separate uniform code and having realised such needs the department has prepared a separate Uniform Code for Medical Devices Marketing Practices (UCMDMP), in consultation with the industry. In order to have wider consultation the draft has been uploaded online and the department expects feedback by April 15^th 2022.

According to the draft, this is a voluntary code. However, if it is found that the respective associations/companies do not comply to the voluntary code then the government may consider making it a statutory code.

To begin with a medical device must not be promoted prior to receipt of the product registration (wherever applicable), by the regulatory authority.

In terms of Evaluation Samples, free samples of the medical devices should not be supplied to any person other than the Health Care Professionals (HCPs), or as per hospital protocol to reach the HCPs.

On the issue of gifts, the draft clearly mentions that companies may occasionally provide modest, appropriate brand recall items/ brand reminders, which are customary business courtesies and are reasonable in value and frequency. However, the value of such brand recalls items/ brand reminders shall not exceed INR 1,000 (Rupees One Thousand). Companies shall maintain proper documentation with respect to expense incurred on such brand reminders.

On the companies engagement with HCPs, the code suggests that the companies may collaborate with HCPs and engage in activities including but not limited to providing consulting services, conducting clinical studies and doing research, participate in company conducted training & education.

In no event, the engagements/collaboration with the HCPs shall be conditional upon any obligation for the HCPs to use, recommend, promote or purchase products of the Medical Device Companies or any of its affiliate’s or intended to influence HCPs to do so.

In terms of money to HCPs, the code is specific, and it says that companies or their associations/representatives shall not pay any cash or monetary grants to any HCP for individual purpose in individual capacity under any pretext. However, companies may provide educational grants to training institutions (such as medical schools, teaching hospitals, hospitals & institutions having approved teaching seats) and to other third-party entities in support of their legitimate scientific, educational and training programs and other activities.

On the issue of providing entertainment and recreation, it categorically states that companies shall not provide or pay for any entertainment or recreational event for HCPs, their staff or their family. Some examples of entertainment and recreational activities include, among others, theater, live comedy or musicals, sporting events, golf, skiing, cruises, spas, or vacation trips. This prohibition applies regardless of (1) the value of the activity; (2) whether the Company engages the HCP as a consultant; or (3) whether the entertainment or recreation is secondary to an educational purpose.

In terms of operationalizing the UCMDMP, the DoP note specifies that All the Medical Device Manufacturer associations in India will have UCMDMP uploaded on their website. Once a complaint is lodged and Association receives information from which it appears that a company may have contravened the code, the managing director or chief executive or equivalent of the company or authorized person(s) of the company concerned will be requested to investigate, take corrective actions and provide a response to the matters of complaint to the Association.