Indian expert panel to probe drugs regulator
India's Health Ministry said Friday it had set up an expert panel to review the operations of its drug regulatory agency, accused of colluding with pharmaceutical firms to approve drugs without trials.
The accusations were levelled in a parliamentary panel report that said officials in the Central Drugs Standard Control Organization (CDSCO) were operating in wilful violation of regulatory practices.
The report, which named a number of international drug majors, said the CDSCO had approved a number of medicines without mandatory final trials, including drugs that are banned in some countries.
In a statement Friday, Health Minister Ghulam Nabi Azad announced the creation of a three-member panel, comprising medical experts and academics, to look into the workings of the CDSCO.
The panel will examine the "validity" of any scientific and statutory basis for approving new drugs without clinical trials and recommend measures to bring about "systemic improvements" in the approval procedure, Azad said.
The parliamentary report had concluded there was sufficient evidence to suggest the existence of a "collusive nexus" between drug manufacturers and CDSCO officials to push some medicines onto the market.
"Such irregular approvals spare drug producers the cost and efforts but put Indian patients at risk," it added.
India's pharmaceutical market has grown by an annual 14 percent in the past five years and, according to PricewaterhouseCoopers, could be worth up to $50 billion by 2020.
As Indian and international drugmakers rush for a slice of the market, the parliamentary report suggested some "expert" reports on drug safety were actually the work of the manufacturers.
"There is adequate documentary evidence to come to the conclusion that many opinions were actually written by invisible hands of drug manufacturers and experts merely obliged by putting their signatures," the panel said.
The CDSCO is responsible for the licensing, marketing and trials of drugs in India.
(c) 2012 AFP
- India probes charges of violations by drugs regulator May 10, 2012 | not rated yet | 0
- FDA panel backs Pfizer drug for kidney cancer Dec 07, 2011 | not rated yet | 0
- New drugs should be compared with existing treatments before approval, say experts Sep 07, 2011 | not rated yet | 0
- Drug-resistant TB blamed on Indian treatment flaws Mar 23, 2012 | not rated yet | 0
- BMJ report into top-selling diabetes drug raises concerns about the drug regulatory system Sep 07, 2010 | not rated yet | 0
- Motion perception revisited: High Phi effect challenges established motion perception assumptions Apr 23, 2013 | 3 / 5 (2) | 2
- Anything you can do I can do better: Neuromolecular foundations of the superiority illusion (Update) Apr 02, 2013 | 4.5 / 5 (11) | 5
- The visual system as economist: Neural resource allocation in visual adaptation Mar 30, 2013 | 5 / 5 (2) | 9
- Separate lives: Neuronal and organismal lifespans decoupled Mar 27, 2013 | 4.9 / 5 (8) | 0
- Sizing things up: The evolutionary neurobiology of scale invariance Feb 28, 2013 | 4.8 / 5 (10) | 14
Pressure-volume curve: Elastic Recoil Pressure don't make sense
May 18, 2013 From pressure-volume curve of the lung and chest wall (attached photo), I don't understand why would the elastic recoil pressure of the lung is...
If you became brain-dead, would you want them to pull the plug?
May 17, 2013 I'd want the rest of me to stay alive. Sure it's a lousy way to live but it beats being all-the-way dead. Maybe if I make it 20 years they'll...
MRI bill question
May 15, 2013 Dear PFers, The hospital gave us a $12k bill for one MRI (head with contrast). The people I talked to at the hospital tell me that they do not...
Ratio of Hydrogen of Oxygen in Dessicated Animal Protein
May 13, 2013 As an experiment, for the past few months I've been consuming at least one portion of Jell-O or unflavored Knox gelatin per day. I'm 64, in very...
Alcohol and acetaminophen
May 13, 2013 Edit: sorry for the typo in the title , can't edit I looked around on google quite a bit and it's very hard to find precise information on the...
Marie Curie's leukemia
May 13, 2013 Does anyone know what might be the cause of Marie Curie's cancer
- More from Physics Forums - Medical Sciences
More news stories
Europe's medicines watchdog said Friday the benefits of acne drug Diane-35, also widely used as a contraceptive, outweigh the risk of developing blood clots in the veins—when correctly prescribed.
Medications May 17, 2013 | not rated yet | 0
Singapore's Agency for Science, Technology and Research (A*STAR) and Switzerland's Cytos Biotechnology AG today announced that the first healthy volunteer has been dosed in a Phase 1 clinical trial with their ...
Medications May 17, 2013 | 5 / 5 (1) | 0
(Medical Xpress)—An aspirin a day may not always keep heart disease away, say two University of Florida cardiologists. But a new algorithm they have developed outlines factors physicians should weigh as ...
Medications May 16, 2013 | 3.5 / 5 (2) | 0 |
(HealthDay)—The U.S. Food and Drug Administration has approved new, lower-dose labeling for the popular sleep drug Ambien (zolpidem) in an effort to cut down on daytime drowsiness that could be a hazard ...
Medications May 15, 2013 | not rated yet | 0
Researchers at the University of Wisconsin have identified a potential new risk factor for obstructive sleep apnea: asthma. Using data from the National Institutes of Health (Heart, Lung, and Blood Institute)-funded Wisconsin ...
1 hour ago | not rated yet | 0 |
A new study looking at sleep-disordered breathing (SDB) and markers for Alzheimer's disease (AD) risk in cerebrospinal fluid (CSF) and neuroimaging adds to the growing body of research linking the two.
1 hour ago | not rated yet | 0 |
Gourmands and foodies everywhere have long recognized ginger as a great way to add a little peppery zing to both sweet and savory dishes; now, a study from researchers at Columbia University shows purified components of the ...
1 hour ago | not rated yet | 0
In their quest to learn more about the variability of cells between and within tissues, biomedical scientists have devised tools capable of simultaneously measuring dozens of characteristics of individual ...
2 hours ago | 5 / 5 (1) | 0 |
Scientists at Johns Hopkins have turned their view of osteoarthritis (OA) inside out. Literally. Instead of seeing the painful degenerative disease as a problem primarily of the cartilage that cushions joints, ...
2 hours ago | 5 / 5 (1) | 0 |
The hunt for an HIV vaccine has gobbled up $8 billion in the past decade, and the failure of the most recent efficacy trial has delivered yet another setback to 26 years of efforts.
6 hours ago | not rated yet | 0