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The Department of Pharmaceuticals (DoP) has amended certain clauses of the Uniform Code of Pharmaceutical Marketing Practices (UCPMP), 2024, to elaborate the method of calculating the value of free samples, and to remove the mandate that the companies should upload the details of the complaints and action taken by the industry associations against such companies to the DoP's UCPMP 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 comes after the industry has represented, "that the existing form for disclosure of monthly marketing expenditure entails significant administrative burden in terms of duplication of efforts and compliance for industry," said the Department.
With a view to promote Ease of Doing Business, the industry has also sought simplification of the reporting form and requirements through submission to respective industry associations and the recording of the price for free samples as the average price charged to the stockist or immediate customer or the average price paid for the purchase of medicines for the same dosage form and strength on annual basis, it added.
Considering the representations, the DoP amended the Code to add a provision with regard to the method of arriving at the value of free samples distributed to healthcare practitioners, in order to clarify the procedure.
According to this, in case the company is the manufacturer of such samples, the samples should be valued on a per unit basis, that is, per tablet/capsule/vial/gram/ml etc., and its value should be the price charged to the stockist or immediate customer on per unit basis for the same dosage form and strength.
In case the company has purchased such samples from another supplier, the purchase price should be used for determining the monetary value of free samples under this Code. The price of 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 medicines for the same dosage form and strength on an annual basis, it added.
The amendment omits a part of another clause, which now results in removal of the mandate that the details of complaints received against a company, the nature of complaint, the company against whom the complaint has been made, the present status of the complaint, including action taken by the Ethics Committee for Pharmaceutical Marketing Practices (ECPMP) of the industry associations, with the UCPMP portal of the DoP.
The existing mandate that these details should remain uploaded for five years in the website of the pharma association under which the company is a member of, will continue.
The amendment further elaborates that the procedure for self declaration by the chief executive officer of the company, with regards to marketing expenditure.
Disclosure of marketing expenditure in the (amended) 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. 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 having done so.
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 of such decision to the DoP and the Association with which it has been submitting the details earlier.
If the company is not a member of any such body, the disclosure shall be made on the UCPMP portal of the DoP, it added.
The amendment further inserts a sub-clause to this, that the Associations shall have a system in place to ensure that the 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 Pharma Marketing Practices, the Apex Committee for Pharma Marketing Practices or any court or other authority or as such committee, court or authority may direct for such purpose.
"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 purposes of such inquiry or decision," it added.
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