 "pharmaceutical sector, pharma sector, medicines, meds")
The government has notified a new legal code to curb the unethical marketing of drugs and banning medical representatives from using “inducement” to access healthcare professionals.
In a communication dated March 12, the Department of Pharmaceuticals (DoP) has asked groups representing the pharmaceutical industry to ensure “strict compliance” to the Uniform Code for Pharmaceutical Marketing Practices (UCPMP) 2024. The code also has norms for claims and comparisons and the nature of the relationship between healthcare professionals and medical representatives for companies. Pharma associations have been asked to constitute a five-member Ethics Committee for Pharma Manufacturing Practices (ECPMP) and set up a dedicated portal on their websites.
Violating the norms can result in penalties ranging from recovery of money to suspension or expulsion of the “incriminated entity” from the association. The ECPMP can probe any entity accused of breaching the norms. Industry sources said it is not yet clear as to under which law this code would be notified and how prosecutions will be done. "There can be two provisions - one the UCPMP is implemented under the Drugs and Cosmetics Act, or it could be under the DPCO, 2013. As of now it is not clear how this will be implemented and brought into action, especially related to penalties," said an industry veteran.
Companies, as members of pharma industry associations, will have to submit a self-declaration within two months of the end of a financial year stating that they are compliant with the UCPMP. "If there is violation to this, and proven guilty, then associations can debar members," he said adding the code is not yet a gazette notification and more of a communication to industry bodies.
Continuing medical education, a demand by the industry, has been allowed in UCPMP. "Engagement of pharmaceutical industry with the healthcare professionals for Continuing Medical Education, Continuing Professional Development or otherwise for conference, seminar, workshop, etc. should only be allowed through a well-defined, transparent, and verifiable set of guidelines based on which the pharmaceutical industry may undertake such expenditures," said the DoP communication to industry associations.
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Informational and educational items mean books, calendars, diaries, journals (including e-journals), dummy device models and clinical treatment guidelines for professionals used in healthcare settings value of which does not exceed Rs 1000 per item can be given to companies as brand reminders. Such items should not have an independent commercial value for the healthcare professionals. This was also a demand from the industry, which claimed that usually the value of such items hardly exceeds Rs 1000-2000.
"The notification of UCPMP 2024 establishes a framework for communication claims, educational activities, samples, and other market initiatives within the knowledge-driven pharmaceutical industry,” said Sudarshan Jain, secretary general, Indian Pharmaceutical Alliance (IPA) which represents large pharma companies. “It clearly lays down what activities are permissible and outlines a complaint procedure involving both industry associations and the Department of Pharmaceuticals. Indeed, it is a step forward towards industry advancement, prioritizing superior patient care and adhering to established norms.”
According to the new guidelines, any drug must not be promoted before it gets marketing approval from the regulatory authority authorising sale or distribution. They say that information about drugs must be balanced, up-to-date, and must not mislead people either directly or by implication. The UCPMP bans the supply of free samples to those who are not qualified to prescribe drugs and prohibits pharmaceutical companies from offering gifts and travel facilities to healthcare professionals or their family members.
