Govt, industry hold talk on issues over marketing code for medical devices

Medical device companies raise issues with the DoP over UDMPMD norms related to disclosure of training expenses and restrictions on overseas training approvals

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Medical device industry representatives have raised concerns with the Department of Pharmaceuticals (DoP) over certain provisions under the recently notified Uniform Code for Marketing Practices for Medical Devices (UDMPMD), during a meeting held on Thursday.

 

The new code seeks to curb unethical marketing practices in the medical devices industry by barring medical representatives and device companies from using inducements or subterfuge to access healthcare professionals.

 

The meeting follows an advisory by the Director General of Health Services (DGHS), directing all government-run hospitals to prohibit medical representatives from directly meeting doctors.

 

While medtech associations and the DoP did not respond to queries sent by Business Standard till the time of going to print, sources indicated that companies flagged concerns related to continuing medical education (CME) necessary to train practitioners on their devices.

 

Many companies argued that, unlike pharmaceuticals, medical device training often requires doctors to be physically present with the device. 

 

The UDMPMD mandates full disclosure of details related to the distribution of evaluation samples (provided to give hands-on experience) and all expenses incurred on CME and training through conferences, workshops and seminars.

 

“The particulars are to be filled on an ongoing basis and mandatorily within two months of the end of every financial year on the UCPMP portal of the department, within the time limit fixed for submitting self-declaration by the executive head of the company,” the DoP notification on the code states.

 

Industry sources added that several companies had sought DoP approval for overseas training programmes, which under the UDMPMD is only allowed under special circumstances. “Some 20 to 25 companies had applied for the approval, but all have been rejected for one reason or another,” said a person familiar with the matter.

 

In a notification dated September 6, 2024, the DoP directed medical device associations to constitute a three- to five-member Ethics Committee for Marketing Practices in Medical Devices (ECMPMD), chaired by their chief executive officer (CEO), and to set up a dedicated portal on their websites. 

 

With the centralised portal not yet operational, the DoP has instructed companies to upload the required information on their India websites—something many multinational corporations (MNCs) may not have in place.

 

“The portal is expected to be ready in the next three to six months,” an official aware of the developments said.