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Tuesday, September 29, 2020

Health Minister petitioned: Medical professionals seek transparency in pharma regulations

The move comes at a time when various drugmakers and vaccine firms have received approvals to either conduct clinical trials or launch their products in the country for use in the battle against Covid-19.

Written by Prabha Raghavan | New Delhi | August 7, 2020 4:49:35 am
Harsh Vardhan, Harsh Vardhan who board chairman, Harsh Vardhan in who, India in who, india lockdown, coronavirus Health Minister Harsh Vardhan (Twitter/@drharshvardhan)

A group of medical professionals and activists have petitioned Health Minister Dr Harsh Vardhan to bring more transparency in the way India’s pharmaceutical industry is regulated, including the way clinical trials are conducted and drugs are approved. The move comes at a time when various drugmakers and vaccine firms have received approvals to either conduct clinical trials or launch their products in the country for use in the battle against Covid-19.

“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,” said the petition drafted by public health activist Dinesh Thakur and co-signed by 13 medical professionals and healthcare and RTI activists. They have made six suggestions to improve transparency in the country’s drug regulations. This includes making clinical trial data public “regardless of the success or failure of the trial”.

According to them, while the Clinical Trials Registry of India (CTRI) offers some window into developments in clinical research, it makes limited disclosures that do not explain deliberations that went into ethics approvals of these trials. It also does not make public the application submitted by the firm to the Drug Controller General of India (DCGI) for permission to conduct the trial, which presumably contains data related to the studies done on animals to check for the safety and effectiveness of the drug. It also does not make public the approvals or rejections of these applications by DCGI.

They also said decisions and file notings relating to applications for approval of new drugs decided by DCGI, including those rejected or withdrawn, must be made public.

The petitioners have also asked for more transparency in inspections conducted by regulatory officials into pharmaceutical products, asking that these inspections as well as the lab test results to check the quality of these drugs be made available in public domain.
“Enforcement actions under the Drugs and Cosmetics Act, such as criminal complaints initiated against drug manufacturers and judgments must be made available to the public,” they stated.

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