Govt Amends Marketing Code for Medical Devices, Details

“In pursuance of clause 14.1 of the Code and in partial modification of this Department’s letter F. No. 31026/23/2022-Policy, dated 6.9.2024 and Circular No. 1 of 2024 of even number, dated 4.10.2024, the undersigned is directed to hereby convey the following amendments to the Code.”

Valuation of Free Evaluation Samples

A major clarification has been inserted under clause 5.2.2(vi), detailing how companies must calculate the monetary value of free evaluation samples distributed to healthcare professionals.

According to the circular:

“(1) 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; and

(2) in case the company has purchased such samples from another supplier, the purchase price should be used… 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 annual basis.”

This change addresses industry concerns about ambiguities in disclosure of sample costs.

Disclosure and Compliance Responsibility

The circular substitutes clause 14.3, making the CEO accountable for UCMPMD compliance:

“The Chief Executive Officer of the company shall be responsible for adherence to this Code. Disclosure of marketing expenditure in the form set out in the Annexure 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.”

If a company is not part of any association, disclosures must be made directly on the UCMPMD portal of the Department of Pharmaceuticals.

Additionally, clause 14.4 mandates secure storage of industry data by associations:

“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… and shared with committees, courts or authorities when required.”

Removal of UCPMP References

The DoP has replaced the word “UCPMP” with “UCMPMD” under clause 9.1 and removed references to the UCPMP portal from clauses 9.5 and 11.10. This aligns the medical devices marketing code with its distinct identity, separate from the pharmaceutical code.

Revised Annexure for Expenditure Reporting

The annexure for expenditure disclosure has been overhauled. Companies must now report detailed heads including:

Value of free evaluation samples distributed

Number and expenditure of education programmes (direct and third-party)

Locations of events

Methodology for calculating expenditure

The declaration requires a digital signature certificate from the company’s executive head.

Extension of FY 2024–25 Disclosure Deadline

Acknowledging industry requests, the DoP has extended the deadline for filing FY 2024–25 disclosures.

The circular states:

“For the financial year 2024-25, the Department hereby extends the time limit for submission of disclosure of the particulars of marketing expenditure and declaration of compliance with the Code… by a further period of one month beyond 31.8.2025, i.e., till 30.9.2025.”

To view the official notice, click the link below: