Responding to a query raised by Bapi Haldar in the Lok Sabha, Minister of State for Chemicals and Fertilizers Anupriya Patel outlined the legal and regulatory measures in place to curb unethical marketing practices by pharmaceutical companies. Haldar had sought details on violations of the Uniform Code of Pharmaceutical Marketing Practices (UCPMP) over the last five years, the action taken, plans to review its efficacy, any proposal to make it legally binding, mechanisms for disclosure of doctor–pharma financial relationships, and steps to curb unethical marketing practices.
Under the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, advertising of any drug for diagnosis, cure, mitigation, treatment or prevention of any disease, disorder or condition specified in the Act’s Schedule is prohibited. “The said Schedule covers most of the prevalent diseases, disorders and conditions and, therefore, pharmaceutical companies are required to rely on doctors to promote their products,” the reply stated.
The Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 prohibit doctors from receiving any gift, cash, monetary grants, travel facilities or hospitality from pharmaceutical or allied healthcare industries. Penalties under these regulations range from censure to removal from the Indian Medical Register or the State Medical Register for periods of three months, six months, one year or more, depending on the value of the benefit received.
Under Section 37 of the Income-tax Act, 1961, any expenditure on such benefits in violation of the IMC Regulations is disallowed as a tax deduction for companies.
The Department of Pharmaceuticals issued the Uniform Code of Pharmaceutical Marketing Practices (UCPMP) in 2015, which has now been replaced with UCPMP, 2024 after a review by a High-Level Committee and stakeholder consultations. The Committee observed that the Code need not be made statutory due to the existing legal framework under the IMC Regulations, 2002.
“UCPMP, 2024 explicitly prohibits the offering of gifts and incentives such as monetary grants, travel facilities and hospitality to doctors or their family members. The prohibitions are backed by penalties, which may include recovery of money or items from the persons concerned, reprimand for the pharmaceutical entity and the publication of full details thereof,” the Government said.
The updated Code also requires disclosure of expenditures on continuing medical education/professional development events and the value of free samples given to doctors. Under the IMC Regulations, doctors must disclose funding sources and any affiliations or professional roles with the pharmaceutical or allied healthcare industries.
Prescription integrity is additionally safeguarded under sub-rule (11A) of rule 65 of the Drugs Rules, 1945, which provides that a pharmacist or any other person dispensing a prescription containing Schedule H, H1, or X drugs cannot substitute the prescribed drug with any other preparation.
“These measures collectively aim to curb unethical marketing practices, promote rational prescription, and safeguard public health interests,” the Minister emphasised.
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