#India – Clinical drug trials in Rajasthan claim 95 lives


STAFF REPORTER, tHE hINDU

291 cases of serious adverse events reported

Drug trials on humans in Rajasthan over the last eight years have claimed 95 lives, while 291 persons experienced serious adverse events, according to the State government’s latest deposition before the Supreme Court in an ongoing public interest litigation.

While informing the apex court of the figures, the Rajasthan government has sought to be made part of the overall monitoring and regulatory framework regarding clinical trials in order to protect the health of its citizens, deal with rogue trials and expedite the compensation process.

The 95 deaths include those caused due to the trials, besides deaths due to the natural history of the disease and other unrelated health events.

Four cases of death were deemed fit for compensation by sponsor companies out of which two had been compensated, while the process of compensating the other two was on.

This information was revealed in an affidavit submitted earlier this year by Rajasthan Chief Secretary C.K.Matthew to the Supreme Court, hearing a public interest litigation petition. A committee appointed by the state government came up with these figures after collecting data from 60 principal investigators regarding 213 clinical trials, conducted between 2005-2012.

However, the total number of deaths could be much higher as a total of 326 trials were conducted in Rajasthan during this period.

Some of the drugs for which trials were conducted include Talactoferril, Kremezin, Aliskirel, SU011248 (code name), Prasugrel and Clopidogrel.

In line with responses from other State governments in the case, the Rajasthan government too, has argued for higher powers to the States in the overall monitoring and regulatory framework regarding clinical trials.

“Certainly, the State government needs to be part of the whole process or else how are we to know what steps are to be taken [to deal with rogue trials],” Mr. Matthew told The Hindu .

In its deposition, a copy of which is with The Hindu , the Rajasthan government argued that while the Drugs and Cosmetic Act 1945 was a Central legislation, the State government was primarily responsible for the health of its citizens.

“The data would clearly reveal that sometimes clinical trials have significant adverse impact on the health of patients…existing rules need to be amended accordingly, especially with regard to immediate care for persons suffering SAEs and…with respect to compensation [in case of mortality],” the State government has argued.

It has also called for the strengthening of the existing framework “with sufficient safeguards…with penalties as well as adequate compensation”.

The government argued in favour of an online monitoring system for persons undergoing trials and a proper accreditation system for the selection of principal investigators in which the State government should have a role to play.

Since almost all Ethics Committees overseeing the propriety of the trial process are in-house bodies of sponsor hospitals of which Principal Investigators are also members, the government has called for Ethics Committees to be detached from trial sponsoring sites/institutes.

According to information submitted to the court by the Union Health Secretary in the case, a total of 2,644 deaths and 11,972 SAEs were reported during clinical trials in India between January 2005 and June 2012.

 


  • State government seeks higher powers in overall monitoring, regulatory framework
  • Government argues in favour of online monitoring system

 

Attn Bangalore- Public Talk by Bhanwari Devi #Gangrape #Vaw #sexualharassment


Dear All,

The Alternative Law Forum invites you to a talk by Bhanwari Devi.The talk
will focus specifically on her battle for justice in the courts after she
was gang-raped in 1992. The attack on her and her husband was the result of
a backlash against her campaign against child marriage in Rajasthan from the
Gujjar community. At the time, Bhanwari Devi was employed as a saathin by
the Rajasthan government as part of the Women’s Development Project. Her
protracted legal battle attracted national and international attention and
resulted in the historic Vishakha judgment, in which the Supreme Court used
international principles to formulate guidelines to address sexual
harassment at the workplace. In 1994, Bhanwari Devi was awarded the Neerja
Bhanot Memorial Award for “her extraordinary courage, conviction and
commitment”.

When: Saturday, 9th March

Where: Alternative Law Forum, 122/4 Infantry Road (opposite Infantry Wedding
Hall), Bangalore 560001

All are welcome.

 

#Rajasthan- Sterlisation Camp -women had to rest on floor due to lack of beds #Vaw #WTFnews


About 90 women and 10 men have been sterilized in Ratangarh (रतनगढ) town in the Churu district of Rajasthan. This is a complete flouting of the prescribed number of sterilisation operations under the government guidelines. The  news report  below also specifies that due to unavailability of beds, women had to rest on the floor.

daily_news_2mar_13_jpr

#Aadhar services to miss Jan 1 deadline-‘ yeh to hona hi tha ‘;-) #UID


200 px

200 px (Photo credit: Wikipedia)

 

TNN | Dec 10, 2012,

 

 

 

JAIPUR: The pilot implementation of Aadhaar enabled services in the three selected districts of Ajmer, Udaipur and Alwar is set to miss the January 1, 2013 deadline as the enrollment of UID cards remains far below the desired level of 80%. As on Friday, Aadhaar cards have been issued to only 21% of the people in Ajmer, while the penetration is 23% in Alwar and 20% in Udaipur.

 

 

A top official involved in project told TOI that given the current enrollment status, it would be difficult to implement the pilot projects from January 1.

 

 

It is not possible for us to implement the pilot projects for Aadhaar enabled services in Udaipur, Alwar and Ajmer from January next year. The level of Aadhaar cards coverage is very low. We are expediting the whole exercise, but we need more time,a said the official preferring anonymity.

 

 

The Centre has announced to roll out the project in 43 districts of the country on pilot basis from the beginning of next calendar year linking 29 government schemes to the Aadhaar. The electronic cash transfers of welfare schemes will be based on Aadhaar (Unique Identification Number) platform.

 

 

However, Rajasthan government was planning to initially link only three schemes such as social security pension, scholarships and benefits under public distribution system to Aadhaar, said the official.

 

 

Given the present status, the rollout schedule announced by chief minister Ashok Gehlot last month to implement the schemes across state may also miss the scheduled timeline.

 

 

Gehlot had set April 1 deadline for CM Rural BPL Awaas Yojana and social security pension schemes. The government has planned to link post-metric and higher education scholarships to Aadhaar from next academic year. February 1, 2013 has been set for payment of salaries to government officials through Aadhaar. But so far, people covered by Aadhaar cards in the state is only a little over 17% of the total population.

 

 

The Kotkasim pilot project in Alwar district has failed to live up to the expectations and unless the government cracks the whip, it may again not only miss the deadline but also fall far behind the finishing line.

 

 

 

 

Rajasthan Government’s disdainful response to women’s plight after family planning operations #Vaw


 

According to the latest news report (December 7, 2012) Rajasthan Government is having plans to compensate Rs. 30,000/- for female sterilisation failures, but it is also to be noted that once again the government is claiming that people are responsible for failure of operations because they do not take ‘precautions’ due to which!  (See the images below)
The Coalition Against Two-Child Norm and coercive Population Policies and a team of organisations in Rajasthan are jointly holding a consultation in Jaipur on the 13th of  December to discuss similar unacceptable issues related family planning policies and their connection with the two-child norm. It is also planned to include a few of the Panchayat representatives from a few areas in Jaipuir.
Inline image 3
Inline image 4

 

Faking Happiness- #Vedanta will adopt 92 rural schools in south Rajasthan


TagsVedanta,Vedanta Rajasthan,Vedanta schools

 
Dec 3. 2012
Udaipur: Vedanta’s group company, Hindustan Zinc has signed an MoU with the Rajasthan Government to adopt 92 Schools in phases in Chittorgarh and Bhilwara District of the state.
The aim is to adopt 92 schools, 72 Government schools in Bhilwara for 5 years and 20 schools in Chittorgarh for 3 years, a company official said.The company would spend about Rs 3.35 Crore on this project.The project would provide basic infrastructure facilities like construction of class rooms, boundary walls of the school, installation of hand pumps, ceiling fans, coolers, construction of toilets, playgrounds, furniture for the children etc, said Pavan Kaushik,Head Corporate Communication.It will also provide scholarships to meritorious students.The company also plans to encourage plantation drive to develop green belt in schools.

To monitor the success of the project, a committee of 5 members has been formed which would have 2 members from Vedanta Hindustan Zinc, 2 from school and 1 member nominated by District Magistrate.

Based on the need of the school authority and assigned budget, the project will be executed by Vedanta Hindustan Zinc.

This would also ensure optimum utilisation of funds.

Earlier Vedanta Hindustan Zinc had provided 1000 computers to 200 government schools in rural areas and e-subject software support to about 500 schools.

The company is also providing daily mid-day meal to over 80,000 students in 2000 government schools in Rajasthan to ensure nutrition support to students.

Most of these children are from poor family and need regular nutrition support.

PTI

Companies can’t acquire SC, ST land: Supreme Court


PTI Sep 20, 2012,  IST Tags: Supreme Court| Scheduled Caste| Schedule Tribe (The Supreme Court said that…)

NEW DELHI: In a significant ruling, the Supreme Court today said that the land belonging to scheduled castes or tribes cannot be bought by non-dalits, including companies as such transactions are unconstitutional. A bench of justices K S Radhakrishnan and Dipak Misra gave the verdict on an appeal by the Rajasthan government against the state high court’s order holding such a sale to be valid in law.

The high court had passed its order on an appeal by a firm, Aanjaney Organic Herbal Pvt Ltd, against the refusal by the state authorities to recognise or grant mutation to the purchase of a plot by the company from a person belonging to scheduled caste. “The Act is a beneficial legislation which takes special care to protect the interest of the members of Schedule Caste and Schedule Tribe. “Section 42 (SC, ST Act) provides some general restrictions on sale, gift and bequest of the interest of Scheduled Caste and Scheduled Tribe, in the whole or part of their holding.

“The reason for such general restrictions is not only to safeguard the interest of the members of Scheduled Caste and Scheduled Tribe, but also to see that they are not being exploited by the members of non-Scheduled Caste and Scheduled Tribe. “We find Section 42(b) of the Act has to be read along with the constitutional provisions and, if so read, the expression ‘who is not a member of the Scheduled Caste or Scheduled Tribe’ would mean a person other than those who has been included in the public notification as per Articles 341 and 342 of the Constitution,” said Justice Radhakrishnan, writing the judgement for the bench.

That property was purchased on September 26, 2005 through a registered sale deed for a consideration of Rs 60,000. The high court had held that such a transfer was valid as the company being a ‘juristic person‘ does not have a caste and, therefore, any transfer made by a Scheduled Caste person would not be hit by Section 42(b) of the Act. “If the contention of the company is accepted, it can purchase land from Scheduled Caste / Scheduled Tribe and then sell it to a non-Scheduled Caste and Schedule Tribe, a situation the legislature wanted to avoid. “A thing which cannot be done directly can not be done indirectly by over-reaching the statutory restriction. “We are, therefore, of the view that the reasoning of the high court that the respondent being a juristic person, the sale effected by a member of Scheduled Caste to a juristic person, which does not have a caste, is not hit by Section 42 of the Act, is untenable and gives a wrong interpretation to the above mentioned provision,” the apex court said.

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