“Enhancing reputation is the best defense against unethical market practices. Companies that have established themselves in the market are reprimanded and their reprimands are posted across the public and social media spaces. And the damage it will do to the company will be significant.'The reputation and value of that company is immeasurable,'' Chawla said.
He added that the “honor and shame” policy was the beginning and the story would continue further.
When asked how the government would consider penalizing those who do not comply with the provisions of the newly notified Uniform Pharmaceutical Marketing Practices (UCPMP) 2024 on March 12, Chawla said, He commented as follows.
The code would restrict pharmaceutical companies from providing personal benefits to medical workers and their families. Restricted benefits include cash or monetary grants for gifts, travel accommodations, entertainment, and marketing activities.
He said the new norms apply to both the government and the corporate sector as a whole.
Chawla on Monday held a comprehensive meeting with stakeholders to discuss implementation of the recently notified Uniform Regulations on Pharmaceutical Sales Practices, 2024. The meeting included representatives from various pharmaceutical organizations, which Chawla stressed was critical to implementing this provision.
Talking about the participants of the conference, Chawla said, “Major pharmaceutical organizations such as the Indian Pharmaceutical Alliance (IPA), which represents 25 of India's largest pharmaceutical companies, OPPI, which plays a similar role for India's multinational pharmaceutical companies, and IDMA; It is made up of representatives from.” “We have an important association of 1,100 mid-sized pharmaceutical manufacturers across the country and the Active Pharmaceutical Ingredients Manufacturers Association, which represents approximately 300 active pharmaceutical ingredient manufacturers across the country. We're representing 1,300 to 1,400 pharmaceutical companies.”
The government has also collected market data from the market performance of pharmaceutical companies over the past three to four years to ensure strict compliance.
“Today's meeting was convened at the end of the financial year and from now on all companies will be required to submit their self-assessments to the association within two months from the end of the financial year. We are preparing for the audit committee. “There are,” Chawla said. . This initiative shall be uploaded directly to his website of the association or his UCPMP portal. Companies that do not comply will automatically be subject to a risk-based audit framework.
The code states that complaints of violations will be handled by each association's Pharmaceutical Marketing Practices Ethics Committee. This committee will consist of three to five members and will be headed by the CEO of the Board of Directors, who will be responsible for compliance with the Code.
The Ministry of Medicines noted that pharmaceutical companies, distributors, agents, wholesalers and retailers should not provide gifts for the personal benefit of healthcare workers or their families. The last time the Ministry of Pharmaceutical Sciences announced his UCPMP was in 2014.
Chawla said the industry is undergoing rapid transformation given its dynamic and evolving nature. “Technology is evolving, telemedicine is here, digital health is here, online prescriptions are here, blockchain technology is here, generative AI is here. So much is happening on that front. “It's happening. So, we needed to evolve a framework that was essential, but flexible enough to adapt to these changes that occur in the market and technology,” he said.
The government decided to adopt the code after a high-level committee headed by NITI Aayog members was set up to look into marketing practices. The committee included the Chairman of the Central Board of Direct Taxes, as well as members of the pharmaceutical and health industries, and gathered input from all stakeholders. As Chawla explained, their recommendations formed the basis of the new code.
According to him, a key feature of this code is its mandatory nature, which distinguishes it from previous voluntary codes.
Why is it required?
Chawla said the new norms will ensure “government oversight, risk-based audits, self-certification and the existence of redress mechanisms.” He also clarified that the new code is quasi-statutory.
The new legislation combines four important statutes into one framework. This is based on internationally recognized ethical marketing practices established by the World Health Assembly. The Act incorporates the Medical Council of India (MCI) regulations on the conduct of doctors, the guidelines of the Drugs and Cosmetics Act on product claims and marketing practices, and the provisions of the Income Tax Act on calculation of income and penalties for non-compliance .
Chawla said, “The Code consolidates these important laws and allows for government evaluation of audit results. It allows for penalties, disciplinary action and remedial action depending on the relevant government agency or authority. I will,” he explained.
However, critics argue that the provision lacks clear penalty provisions. In response, Chawla explained that Section 12 of the Code outlines his five subsections detailing the penalties.
He said: “When drafting the code, we consider our audience. “However, there may be differences in interpretation among code enforcers and government agencies.” . ”
Chawla went on to say, “If we look at the code carefully, it explicitly mentions certain laws like advertising practices, income tax laws, MCI regulations, etc. In my opinion, this aspect is extremely important.” Ta.
“Simply put, maintaining a good reputation is the most effective defense against unethical market practices, and that is what this code aims to achieve,” he concluded.
