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The new rules move reporting from monthly to annual filings, with CEOs held responsible for compliance
The changes are aimed at reducing duplication of effort while making company CEOs accountable for adherence. The code applies to drugs and medical devices. Representational image: AFP
The Narendra Modi government has amended the pharma marketing guidelines, Uniform Code for Pharmaceutical Marketing Practices (UCPMP), dropping the requirement for monthly disclosures and removing the word “voluntary” from the framework.
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The revised code, seen by News18, shifts compliance to annual filings through industry associations, clarifies valuation rules for free samples, and mandates data retention for at least five years. The changes are aimed at reducing duplication of effort while making company CEOs accountable for adherence. The code applies to drugs and medical devices.
Shift from monthly to annual disclosure
According to the circular issued by the department of pharmaceuticals, dated September 1, the industry had 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 and has sought, with a view to promote ease of doing business, simplification of the reporting form and requirements”.
The revised code removes the earlier requirement of filing monthly marketing expense reports and instead moves to yearly reporting. It specifies that “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 part of more than one association, the circular adds that it “shall, at its option, submit the disclosure made in the said form to any one association of which it is a member”.
Earlier disclosures had to be uploaded to the government portal. Now, disclosures will be made on the websites of industry associations.
Valuation of free samples clarified
The document lays down detailed guidance on how samples must be valued. The document explains how companies should calculate the value of free samples. If a company makes the samples itself, the value will be based on the price it charges to stockists or its immediate customers. If the samples are bought from another supplier, the purchase price will be used to determine their value. It states that “in case the company is the manufacturer of such samples, the samples should be valued on a per unit basis… and its value should be the price charged to the stockist or immediate customer”. For firms that procure samples from another supplier, “the purchase price should be used for determining the monetary value of free samples under this code”.
CEO responsibility and data retention
Responsibility for compliance continues to rest with company leadership, with the code stating that “the Chief Executive Officer of the company shall be responsible for adherence to this code”.
Industry associations have also been tasked with ensuring safe record-keeping, with the amendment requiring that “such data shall be retained for a minimum period of five years, or for such a longer period as may be necessary for the purpose of facilitating inquiry into or decision on any complaint made”.
About the Author
Himani Chandna, Associate Editor at CNN News18, specialises in healthcare and pharmaceuticals. With firsthand insights into India’s COVID-19 battle, she brings a seasoned perspective. She is particularly pass…Read More
Himani Chandna, Associate Editor at CNN News18, specialises in healthcare and pharmaceuticals. With firsthand insights into India’s COVID-19 battle, she brings a seasoned perspective. She is particularly pass… Read More
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