DoP to form panel of auditors for risk-based marketing audit of drug firms

Industry insiders expressed concerns around how the new UCPMP would be implemented and how anyone found guilty of violations of the code would be penalised

As the Centre notified a Uniform Code for Pharmaceutical Marketing Practices (UCPMP) to curb unethical practices in the industry, the Department of Pharmaceuticals (DoP) will now establish a panel of auditors tasked to conduct risk-based audits of marketing spends of drug firms.

Speaking to Business Standard, Arunish Chawla, secretary, DoP said, “The earlier code was voluntary and now this has been made mandatory. This will be implemented in a hub and spoke mode where each pharma association will have a UCPMP portal. These in turn will be linked to the main UCPMP portal of the DoP. The policy division of the DoP will be handling this and there will be a government oversight.” The DoP will also have a panel of auditors who can undertake risk-based audits from time to time, he said.

Industry insiders, however, expressed concerns about how the new UCPMP would be implemented and how anyone found guilty of violations of the code would be penalised.

Chawla explained, “As for implementation, Section 12 of the code speaks about civil, penal and remedial actions whereby any government agency or authority can be brought into the loop in accordance with the statute and nature of the complaint. This is when any disciplinary, penal or remedial action lies within the domain of any agency or authority of the government.” The idea is to strike a balance between cooperative and collaborative compliance that will help in the implementation of this new Code, he said.

In a communication dated March 12, DoP has asked groups representing the pharmaceutical industry to ensure “strict compliance”. 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 under UCPMP 2024 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.

Compliance responsibility

The Chief Executive Officer of a pharma company will be responsible for ensuring compliance with this Code. A self-declaration, as per the provided format, must be submitted by the company’s executive head within two months after the end of each financial year to the pharma association for uploading on its website. Alternatively, if the CEO is not a member of such an association, or is a member of multiple bodies, the declaration should be submitted directly to the UCPMP portal of the Department of Pharmaceuticals.

Continuing medical education, a demand by the industry, has been allowed under the UCPMP. It will allow pharma companies to organise conferences for educational purposes with medical practitioners. Information and academic items like books, calendars, journals (including e-journals), dummy device models and clinical guidelines that are not valued above Rs 1,000 per item can be provided to companies for brand reminders. 

“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.

Gifts and incentives

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.

Doctors, on the other hand, said that most medical representatives offer inexpensive gifts. Suresh Kumar Arora, former president, Indian Medical Association, Faridabad said, “Most medical representatives offer very cheap gifts as brand reminders, such as pens and diaries but there are less instances of MRs offering international trips.”

Mohsin Wali, Senior Consultant - Medicine, Sir Gangaram Hospital, however, admitted that there indeed was a practice of unethical marketing. “There was a practice where pharma companies used to offer incentives as an extended gesture to lure doctors. While you won’t find doctors in metropolitan cities accepting these kinds of favours, it is in smaller towns and cities that doctors, some of whom have not even done MBBS engage in such practices,” he said.

Wali believes that while it is okay if the government is keeping track of this, doctors should also conduct self-audits before favouring any company.

Dos

Pharma associations should form a five-member ethics committee for implementation of norms

Only items whose value does not exceed ~1,000 per unit can be given to companies as brand reminders

Don'ts
 

Drugs must not be promoted prior to receipt of marketing approval

Free samples should not be given to those unqualified to prescribe such products

Gifts and travel facilities shouldn't be given to health care professionals by firms