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The Department of Pharmaceuticals (DoP) has amended certain clauses of the Uniform Code for Marketing Practices in Medical Devices (UCMPMD), 2024, 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.
With the amendment, the Department has further extended the timeline for submission of details of marketing expenditure and declaration of compliance with the Code, for another one month, till September 30, 2025. The Department also amended the existing form for submission as part of disclosure.
The amendment follows requests from the industry associations for simplification of disclosure procedure and suggestions made on the matter, said the DoP while issuing a circular amending the Code.
The Department amended the clause related to the evaluation of samples, in the UCMPMD, 2024, adding a sub-clause detailing the method for calculation of the value of free evaluation samples to healthcare professionals.
The method for calculation is for the purpose of brand reminders, evaluation samples and demonstration products, and the disclosure of marketing expenditure in the form provided by the DoP along with the Code. The DoP has also amended the form, in tune with this requirement.
For the calculation of value, "in case the company is the manufacturer of such samples, the samples should be valued on a per unit basis, i.e., per device/vial/ml etc., and its value should be the price charged to the stockist or immediate customer on per unit basis for the same make, brand, product variant and value of the medical device," says the amendment.
In case the company has purchased such samples from another supplier, the purchase price should be used for determining the monetary value of free evaluation samples under the Code. The price of such free samples should be recorded as the average price charged to the stockist or immediate customer, or the average price paid for the purchase of the medical device for the same make, brand, product variant and value on an annual basis, it added.
It also removes a condition in the existing Code that the decision of the Ethics Committee for Marketing Practices in Medical Devices (ECMPMD) on any complaint against violation of the code by its members should be uploaded to the UCPMP portal of the DoP. This means that the ECMPMD has to now upload its decision on any complaint only in the respective association's portal alone, and not on any government website.
The clause that all Medical Device Associations should share on their website the details of complaints received, the company against whom the complaint was received, the action taken on the complaint and such details should remain uploaded for five years, and upload the details to the UCPMP portal of the DoP has also been amended to remove the mandate on uploading the details to the DoP's website.
The amendment also elaborates the method of annual submission of self declaration by the companies with the industry association, and the procedures for the associations to store the data and provide it to the Courts of the authorities at their direction.
Disclosure of marketing expenditure in the form provided by the DoP shall be submitted by the executive head of the company within two months of the end of every financial year or be uploaded on the website of the Association of which the company is a member, says the amendment.
In case the company is a member of more than one Association, it shall, at its option, submit the disclosure made in the said form to any one Association of which it is a member, while informing the other Association(s) of the submission.
Thereafter, the company shall continue to disclose its expenditure to the same Association to which it first made the disclosure, unless the company ceases to be a member of that Association, and the company decides to start disclosing to another Association of which it is a member, with due intimation to the DoP and the Association with which it has been submitting the report in previous years.
In case the company is not a member of any such body, the disclosure shall be made on the UCMPMD portal of the Department.
"The Associations shall have a system in place to ensure that data disclosed by its members is stored securely and is adequately protected. Such data shall be retained for a minimum period of five years, or for such longer period as may be necessary for the purpose of facilitating inquiry into or decision on any complaint made or proceeding instituted before the Ethics Committee for Marketing Practices in Medical Devices, the Apex Committee for Marketing Practices in Medical Devices or any court or other authority or as such committee, court or authority may direct for such purpose," added a fresh insert into the Code.
"The Associations shall also have a system in place to share such data or information, without affecting the integrity of the same in any manner, on being required to do so by such committee, court or authority for the purpose of such inquiry or decision," it added.
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