The matter came up before a bench of Justices Vikram Nath and Sandeep Mehta. During the hearing, Solicitor General Tushar Mehta submitted, “A statutory regime already exists, but I’ll need time to place it before the court.”
As per a recent media report by the LawChakra, Justice Vikram Nath immediately raised a pointed query, asking, “Regime is there, but is it actually being enforced?”
Senior Advocate Kapil Sibal, appearing for one of the parties, added, “In 2024, a new regulatory framework was introduced.”
The Medical Dialogues team had earlier reported that the Department of Pharmaceuticals (DoP) had amended the UCPMP 2024 to ease compliance for pharmaceutical companies. The amendments introduced clarity on the valuation of free samples, shifted the responsibility of marketing expenditure disclosure to industry associations, replaced the annexure form, and extended the submission timeline for FY 2024-25.
“(i) In case the company is the manufacturer of such samples, the samples should be valued on a per unit basis, i.e., per tablet/capsule/vial/gram/ml, and its value should be the price charged to the stockist or immediate customer on a per unit basis for the same dosage form and strength; and
(ii) 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.”
However, Justice Sandeep Mehta raised concerns over the effectiveness of the framework, remarking, “If it’s a toothless tiger, what’s the purpose?”
To this, Solicitor General Mehta countered, “It’s a tiger with teeth.”
After hearing the submissions, the Court granted time for the government to place details of the regulatory framework on record and directed that the matter be listed again on October 7. On the joint request of SG Tushar Mehta and Senior Advocate Kapil Sibal, the Bench also tagged Writ Petition (C) 794/2023 to be heard along with the case.
Law Chakra reports that the petition further stressed that “This code is enforceable against doctors, however, does not apply to drug companies, leading to anomalous situations where doctors’ licenses are cancelled for misconduct which is actuated, encouraged, aided, and abetted by pharma companies. The pharma companies go scot-free.”
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