The Department of Pharmaceuticals (DoP) has amended the Uniform Code for Marketing Practices in Medical Devices (UCMPMD), 2024 to remove the mandate that the medical devices industry should get a prior approval from the DoP to conduct trainings of Health Care Professionals (HCPs) in foreign locations. The move comes as part of reducing compliance burden, following requests from several industry associations, says the Department.
The amendment has been brought into various sections in the Code, including the aspects related to continuing medical education, travel-related and hospitality-related clauses in the Code on relationship of the medical devices industry with the HCPs.
"Several industry associations and members have raised the problems being faced by the industry in respect of foreign training of HCPs on multiple forums on several occasions and requested to introduce suitable amendments to Section 6.2 of UCMPMD in order to bring predictability to foreign training approvals, ensure timeliness in processing such requests and for reducing the overall compliance burden for the industry," said the Department while issuing the amendment.
The Clause 6.2(i) of the Code currently prohibits conducting continuing medical education events in foreign locations, except for advanced clinical training in exceptional circumstances like non-availability of trainers or equipment and products within the country. It also stipulates that the companies should file detailed justification, details of the training, along with details of participating HCPs, duration and location of training, trainers, expenditure to be incurred on travel and boarding, among others, to the Department at least three months in advance before the scheduled date. It also stipulates that foreign training may be permitted only based on specific approval of the Department.
The Department has now amended this clause, removing the reference to prohibition, substituting it with "Conduct of such events in foreign locations should generally be avoided except for advanced clinical training, or demonstrations by experts, if such equipment or experts are not available in the country."
"Trainings should be provided in the countries where such equipment is available and functional along with the availability of experts who are willing to demonstrate and mentor the trainees," it adds.
Besides, in the place of the requirement to submit the details to the Department three months in advance and seek mandatory approval, the Code now directs the companies to "share details of training, justification, details of participants, estimated expenditure for the entire programme etc., at least one month in advance, with their respective Industry Associations, which will then place it in public domain."
"No approval from DoP or any other authority shall however be required," declares the amendment. It also warns the companies that it shall be the responsibility of the medical device company to adhere to all the provisions of the UCMPMD in letter and spirit, while planning and organizing such training programmes.
"Any violation shall be dealt with in accordance with provisions contained in Sections 12 and 13 of the Code," it adds.
The Sections 12 of the Code entrusts the Ethics Committee for Marketing Practices in Medical Device (ECMPMD) in each Association to take actions against the company violating the Uniform Code, including suspension of expelling of the entity from the association, reprimand the entity and publish full details of such reprimand, ask the entity to issue a corrective statement, among others.
Section 13 details the appeal process in case a party to the complaint is dissatisfied with the decision of the ECMPMD, with the Apex Committee for Marketing Practices in Medical Devices (ACMPMD) headed by the head of DoP. The ACMPMD has the authority to prescribe any penalties or make a reference to an appropriate agency or an authority of the government, regarding the violation.
The clause 8.2 of the Code so far mandated that the companies or their representatives should not extend travel facilities inside or outside the country to HCPs except the person is a speaker for a Continuing Medical Education (CME) or a Continuing Professional Development (CPD) programme or a participant in a training programme and the company should get specific approval from the Department for the same.
The clause has now been amended to omit the condition mandating obtaining approval from the Department prior to the travel.
Similar amendment removing the condition for prior approval from the Department has been made for clause 8.3, which is related to offering hospitality to the HCP, which will remain restricted to the HCPs only if he or she is a speaker for a CME or a CPD programme or participant in a training programme.
The Code as per the National Medical Commission Registered Medical Practitioner (Professional Conduct) Regulations, 2023, as amended from time to time, will prevail, if any item is missing in the restrictions mentioned in the UCMPMD, said the amendment, while earlier, the regulation governing the Code was the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulation, 2002.
Amending the Code, the DoP has sought the four associations related to the industry - Association of Indian Medical Devices Industry (AiMeD), Medical Technology Association of India (MTaI), Association of Diagnostic Manufacturers of India (ADMI), and the Federation of India Chambers of Commerce and Industry (FICCI), to place the revised Code on their respective web portal and also take appropriate action as specified in the amended Code.
The Department has issued the UCMPMD 2024 through a circular on October 4, 2024, prohibiting medical devices companies from offering gifts, travel benefits, hospitality, and monetary grants, while allowing brand reminders, evaluation samples, continuing medical education and support for research.
It was amended in September 2025 to simplified annual reporting format, and later during the year, to elaborate the method of calculating the value of free samples distributed to the healthcare professionals and to remove the mandate that the companies should upload the details of the complaints and action taken by the industry associations to the DoP's dedicated portal. |