Source: Indian Express
In its latest guidelines to prevent unethical pharma industry practices that can influence healthcare professionals, the Union government has allowed firms to arrange medical education workshops and provide research grants for healthcare professionals, provided these are done in a transparent manner.
“…Conference, seminar, workshop, etc. should only be allowed through a well-defined, transparent, and verifiable set of guidelines,” says the Uniform Code for Pharmaceutical Marketing Practices (UCPMP-2024) that was sent to all pharmaceutical associations on Tuesday.
The guidelines prohibit companies from conducting continued medical education (CME) workshops in foreign countries. Companies must also share details of such workshops on their website, including the expenditure they incurred. The firms “may be subject to independent, random, or risk-based audit”.
The organisers must also share the process to select participants and speakers, and all involved must comply with income tax provisions.
The guidelines allow the industry to support research for studies authorised by bodies such as the Indian Council for Medical Research or the Drug Controller General of India.
But in such cases, healthcare professionals should also have been engaged as a consultant or advisor on a honorarium subject to tax provisions. All expenditures by the company must also comply with tax provisions.
The new set of guidelines maintains a range of restrictions from the previous version in operation since 2015. Pharma firms are still barred from giving various forms of gifts to healthcare workers and their families — such as travel, accommodation and monetary grants.
“All associations are requested to constitute an Ethics Committee for Pharmaceutical Marketing Practices (ECPMP), set up a dedicated UCPMP portal on their website, and take further necessary steps towards implementation of this Code,” the guidelines say.
“In cases where disciplinary, penal, or remedial action lies within the domain of any agency or authority of the Government in accordance with the statute, the Committee may send its recommendations to such agency or authority through the Department of Pharmaceuticals,” they say.
It retains other penalties such as suspension from the association, a reprimand with details made public, and recovery of money or items.
UCPMP-2024 will be applicable to medical device manufacturers as well. “The provisions of this Code, unless exempted, … shall apply … to medical devices and companies or entities manufacturing or dealing with the sale and distribution of such products,” the guidelines issued on Tuesday said.
The new guidelines also extended the time up to which a complaint can be entertained after a breach of the code from three months to six months. “The complaint must be made within six months of the alleged breach of the Code, with a maximum of another six months for reasonable delay that can be explained in writing.”
