It is extremely difficult to regulate pharmaceutical industry as it is a multi-layered institution. The industry should not be allowed to be driven by only profits. The government has to make sure that the industry is meeting quality standard, ethics and other regulations. Pharma industry has to ensure that the medicine is cheap, affordable and accessible without compromising on the quality. Innovation is another important aspect of pharma industry. Balancing the profit interests with the welfare of patients is not an easy task.
If the industry fails to do so, it invites criticism from all quarters. It also undermines the credibility of the industry. Scientific research, welfare of patients also get adversely affected.
Recently, a group of medical professionals and activists wrote to the Union Health Minister, requesting him to bring changes in the way the pharma industry is regulated, so that it becomes more transparent. They also requested the ministry to make the pharma industry more transparent about clinical trials. There should be more transparency in the approval of drugs as well.
The petition was drafted by public health activist Dinesh Thakur and co-signed by 13 medical professionals and healthcare and RTI activists, says: “For far too long, we have known about the corruption in the drug approval process; the unholy nexus between drug manufacturers and medical experts, and the inaction against manufacturers of substandard and ineffective medicines. The troubling state of affairs, we believe, is a direct fallout of systemic opacity prevalent within the institutions responsible for regulating the pharmaceutical industry.”
In this backdrop, Dr PD Vaghela, Secretary, Department of Pharmaceuticals (DoP) held a review meeting with industry stakeholders. The meeting was organized with an aim to have an open and frank discussion with the industry leaders about their preparedness to implement the Uniform Code of Pharmaceutical Marketing Practices (UCPMP) in India.
In the virtual meeting, the DoP secretary also raised the issues related black marketing of COVID-19 treatment medicines.
According to a report by the Economic Times, the DoP secretary expressed his displeasure at the status of implementation of UCPMP in the virtual meeting.
Dr Viranchi Shah, National Vice President, IDMA informed, “IDMA agrees principally with the government’s stand of having a voluntary code of ethics for marketing practices in pharmaceuticals. IDMA has already uploaded on its website the UCPMP guidelines. We have also set up an apex committee and ethics committee as required by DoP. We have also updated the DoP of these compliances.”
UCPMP was notified in December 2014 by the DOP. As per the notification, it was to be implemented by the pharma industry on a voluntary basis for six months starting from January 2015.
Since then, the department of pharmaceutical (DoP) held many meetings with the industry, however none of these meetings included civil society groups representing patient interests.
A study, done by Partners of Change, had found that the department of pharmaceutical industry kept issuing notifications extending the voluntary code even though companies did not honour the code. The report also hinted at wider nexus between pharma industry and policy makers.