Monday, July 15, 2013


This makes me smile.  Lots.  I have been outraged by the design of the cervical cancer studies on the women in India.  I mentioned it on Friday for other reasons and then, this story was brought to my attention by my twitter pals @LungCancerFaces.  We watch each other's backs and we share stories.  I hadn't seen this and I am ELATED.

These rules were implemented in January.  The reason for the story in the Wall Street Journal is because clinical trials in India are being impacted and because of these regulations, fewer trial will be conducted in that country.

Basically, the Indian government had already addressed my concerns a month before my initial post.  It begs the question.... Why that comment about my armchair activism???

From the WSJ.... highlights are mine..... and not from the original article...

MUMBAI—Clinical trials by foreign pharmaceutical companies in India have slowed down due to new government rules that complicate testing for new drugs.
India's government implemented rules in January that impose a new approval process for trials and compensation packages for patients who fall sick or die during testing.
The Health Ministry signed the laws after it found in a probe last year that new drugs in some cases were being tested on patients without informing them. The probe was ordered by the Supreme Court after a nonprofit group in the central state of Madhya Pradesh complained.
Earlier in 2012, an Indian parliamentary committee claimed in a report that Central Drugs Standard Control Organization, the regulatory body that oversees India's drug market, approved the sale of several drugs that hadn't been tested on Indian patients, as required by law.
In response, the government imposed the new laws and has delayed processing applications for clinical trials, according to foreign and Indian drug company executives. Pharmaceutical firms, meanwhile, also aren't applying to conduct fresh clinical trials due to worries about some of the provisions in the new laws.
Executives say they are concerned about a requirement that companies foot the bill for patients' total medical needs while they are part of any trial, which could cause costs to soar. The European Union mandates compensation related to death or injury directly related to a trial; the U.S. has no mandatory compensation rules.
"The new rules in India call for free medical management and there is a lot of ambiguity to the term," said Ranjit Shahani, vice chairman of Novartis AG'sNOVN.VX 0.00% India unit. "Are you asking for lifelong free treatment even after the person has been cured? Also, does medical management include only medicines or also critical care?"
Some pharmaceutical executives say they also fear lengthy delays in applications because of a new requirement that independent ethical committees that oversee clinical trials have to register with the regulator.
Drug makers conducted 262 trials in 2012, down from 321 the previous year and 500 in 2010, according to government data. So far in 2013, the government has given the go-ahead for only 56 trials, according to Health Ministry officials.
The red tape means India is missing out on a booming global business for clinical trials. Some 40% of trials registered with the U.S. government are conducted overseas, where costs are lower and patients often more willing to sign up.
India, with a 1.2 billion population and costs for trials that are about half those in the U.S., should be an ideal testing ground for new drugs. Instead, companies are shifting to other Asian nations such as China, Singapore and South Korea for clinical trials, said Mr. Shahani.
Drug companies are conducting 2,247 clinical trials in India, according to data registered with the U.S. Department of Health, or about half the number of trials taking place in China or South Korea.
Supporters of the new rules say they are necessary to stop unethical behavior. G.N. Singh, the Drug Controller General of India, said in an interview the regulations are important "to protect the rights of common people."
The parliamentary committee, in its report, found that between January 2008 and October 2010, the regulator approved 33 new drugs without trials on Indian patients. Mr. Singh said the regulator is investigating officials who allegedly approved drugs without trials but hasn't suspended anyone.
The government is appointing more inspectors to oversee trials. Mr. Singh said the drug regulator had only 19 inspectors in 2008. It currently has 300 and will ratchet that up to 700 in the next three years.
"Earlier, there was no regulation to register and monitor ethics committees, which is why there were rampant cases of unethical trials," said Mr. Singh.
Critics say the government's move is causing a bureaucratic logjam.
More than 300 ethics committees, which are run by hospitals or research organizations, have applied to the drug regulator for registration since January. But the government has only approved a handful of these, said a Health Ministry official.
"We have to examine and verify the authenticity of each ethics committee before approving them. That takes some time," the official said.
Trials previously could be approved by the drug regulator. Under the new rules, several government advisory panels as well as senior Health Ministry bureaucrats must scrutinize the applications.
Kiran Mazumdar-Shaw, founder and chairwoman of Biocon Ltd., 532523.BY +0.19%the biggest biotechnology company in India by sales, said the government is engaging in "over-regulation."
Ms. Mazumdar-Shaw said Biocon, like other big companies, follows high standards in trials and has been tarred by the actions of a minority.
"If we do not have a conducive environment for clinical trials in India," she said, "companies like Biocon and others will be forced to take these studies to other global markets outside India, which will be a huge setback to Indian patients."
The Organization of Pharmaceutical Producers of India, a lobbying group representing foreign and local companies, has written to the Health Ministry asking for an overhaul of the new laws.
Ajay Piramal, chairman of Piramal Enterprises Ltd., 500302.BY +0.04% an Indian drug producer, said the government will "have to" change the rules if it wants clinical trials in the country. Piramal plans to spend $80 million this year on drug testing but has decided to move the clinical trials to the U.S., Mr. Piramal said.
For foreign drug companies, the rules could serve as another disincentive to bring branded medicines to India after a landmark Supreme Court ruling in April rejected Novartis's attempts to win patent protection for its cancer drug, Glivec, known in the U.S. as Gleevec.
An official for Bayer AG, BAYN.XE +0.92% the German drug maker, said "the situation in India is getting increasingly complicated, due to the current government rules." While Bayer hasn't decided to stop testing new drugs in the country, it "will carefully assess the situation" before planning its next trial, the official said.

1 comment:

  1. dear AnneMarie,

    this makes me smile, too. actually, makes my heart sing - with fist pumps.

    much love to you, XOXOXOXO



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