The apex court while expressing its serious concern, however, refrained from passing any blanket ban on the trials and instead sought a comprehensive reply from the Centre on the issues
New Delhi: Taking a serious view of alleged use of human beings as guinea pigs for clinical trials by drug companies, the Supreme Court on Monday asked the Centre and various states governments to reply to the allegation, reports PTI.
A bench of justices RM Lodha and AR Dave also directed the Union government to come out with details of the deaths, if any, and the side effects and compensation, if any, paid to the victims or their family members.
The apex court's direction came during the hearing of a public interest litigation (PIL) petition, filed by NGO Swasthya Adhikar Manch, alleging large scale clinical drug trials across the country by various pharmaceutical firms using Indian citizens as guinea pigs in those tests.
"We can even issue a one-line direction that all these clinical trials which affect many people must stop forthwith. It must suffice, we are very serious about it," the apex court told Additional Solicitor General Siddharth Luthra.
The bench while expressing its serious concern, however, refrained from passing any blanket ban on the trials and instead sought a comprehensive reply from the Centre on the four issues.
The issues included number of applications received by the Union government for clinical trials between 1 January 2005 and 30 June 2012.
The bench secondly wanted to know "the number of deaths, if any, suffered by subjects of clinical trials and if yes, the number and nature of deaths."
Thirdly, the bench sought to know "the serious side effects, if any, suffered by subjects of clinical trial and if yes, the number of such side effects and nature of side effects."
The bench also asked if any compensation was paid to the subjects who suffered side effects or to the family of subjects who died.
Appearing for the NGO, Counsel Sanjay Parekh alleged the clinical trials by several pharmaceutical companies were going on indiscriminately in various states, senior counsel Dushyant Dave for the Madhya Pradesh government said the states cannot be faulted for the tests.
He argued that the permissions for trials were granted by the Central government without consulting the states.
The argument, however, did not impress the bench which pointed out that the said clinical trials were conducted in state governments' hospitals whose employees and doctors are under the control of the respective state governments.
It then proceeded to issue notices to all the states, through their chief secretaries, for their responses and posted the matter for further hearing after eight weeks.
The notice was not issued to the Madhya Pradesh government as it is a party before the court.
Detailing several cases of alleged illegal drug trials in Indore in the central state of Madhya Pradesh, the NGO has said, in its petition, "Over 3,300 patients were used for the tests. Approximately 15 government doctors were involved.
About 40 private doctors in 10 private hospitals were involved.
"Clinical trials were conducted on 233 mentally-ill patients, 1,833 children in the age group of one day to 15 years....Approximately Rs5.5 crore were paid to the government doctors alone. In 2008, there were 288 deaths, in 2009, there were 637 deaths, and in 2010, there were 597 deaths," it has alleged.
It claimed there was lack of transparency in clinical trials as the subjects were not aware of their rights.
It said majority of people on whom the tests were performed were poor and illiterate, came from marginalised communities and suffered serious adverse effects.
The meeting of the GoM on Land Acquisition Bill remained divided over the issue of retrospective acquisitions and the consent required from land owners
New Delhi: The meeting of a Group of Minister (GoM) on Land Acquisition Bill on Monday remained divided over the issue of retrospective acquisitions and the consent required from land owners with Indian Agriculture Minister Sharad Pawar saying two-three meetings are required to finalise the bill, reports PTI.
During the last meeting too, the same issues had divided the members of the GoM headed by Pawar.
"No final view on retrospective clause could happen. We have not taken any final call on the suggestion that consent of two-third people will be required," a source familiar with the development said.
In Monday's meeting, some Ministers also demanded to retain the original clause of seeking consent of 80% of people (land owners) for acquiring land.
The 80% clause was earlier changed to seeking the consent of two-third (66%) of the land owners for making such acquisitions.
Talking to reporters after the meeting, Pawar said, "Two or three more meetings are needed for finalising the bill."
He said all the issues will be settled and the bill will be finalised in two or three more meetings.
"All ministers except Finance Minister P Chidambaram and Planning Commission Deputy Chairman Montek Singh Ahluwalia were present in the meeting. It (more meetings) will get done before this week," the sources said.
The first meeting of the GoM on the Land Acquisition Bill last month had witnessed a strong demand by some members for retaining a window of retrospective application which was done away with earlier.
The meeting had discussed threadbare the contentious clause of prospectively in the Bill and a question of Rehabilitation and Resettlement package on par with the Land Acquisition bill for the affected parties in mineral-rich forest areas.
Considering the protest from the industries and other infrastructure Ministries, the Rural Development Ministry has said it has made changes in the controversial clause which had said that the Bill would apply retrospectively.
According to this clause, the Bill would be applicable to all cases of land acquisition before the date of commencement of the Act if the award under the 1894 Act has not been made.
The Rs2,500-crore IPO of the state-run Rashtriya Ispat Nigam or RINL has been deferred twice since the filing of the draft documents with SEBI
New Delhi: Indian government on Monday said it will kickstart its ambitious Rs30,000 crore disinvestment programme with stake sale in Rashtriya Ispat Nigam Ltd (RINL), this month, reports PTI.
"We have lined up all the cases for the next six months. The first case (RINL) is coming up sometime this month," Finance Minister P Chidambaram told reporters at the Economic Editors' Conference.
The Rs2,500-crore initial public offering (IPO) of the state-run RINL has been deferred twice since the filing of the draft documents with the market regulator Securities and Exchange Board of India (SEBI) on 18th May.
An Empowered Group of Ministers (EGoM) is likely to meet on Tuesday to decide on the date and pricing of the IPO, a source said.
The Cabinet Committee on Economic Affairs in January had approved disinvestment of 10% of the government's 100% stake in the firm.
An official source said that government has identified four more PSUs -- NMDC, NTPC, Power Grid Corporation (PGCIL) and Engineers India (EIL) -- for divesting its minority stake.
"We have floated a paper for inter-ministerial consultation for disinvestment of NMDC, NTPC, EIL and PGCIL and the proposals would soon come up before the Cabinet," the source said.
The Department of Disinvestment (DoD), the nodal point for conducting PSU stake sale, has already got Cabinet approval for stake sale in seven companies, including RINL, Hindustan Copper, Oil India, MMTC, NALCO.
The government plans to raise Rs30,000 crore through disinvestments in 2012-13.
On the budgeted target for disinvestment, Chidambaram said, "I will be quite happy if I can meet the target and complete the timetable (for disinvestment) as laid down.
Because if we do it in the five-and-a-half months that's indeed fast-tracking".
Chidambaram said reforms are required in coal, mining, power, petroleum and natural gas, as well as infrastructure sectors to help create jobs
"There should also be no controversy over reforms in the coal, mining, power, petroleum & natural gas, and infrastructure sectors including roads, railway and shipping.
It is these sectors that are the drivers of growth," he said.
Chidambaram said the first comprehensive Cabinet paper on allowing FDI in retail was prepared by the NDA Government in 2002, in which it acknowledged that FDI in retail was essential to improve the supply chain in agriculture which alone will bring benefits to both producers and consumers.
"That paper also endorsed the argument that FDI in retail will generate millions of jobs. The idea was never rejected.
So, why should there be a controversy when the Government announced its intention to lay down guidelines in order to enable FDI in retail," he questioned.
The Indian government had last month had allowed 51% FDI in multi-brand retail.
Saying that the implementation of FDI is left to the discretion of the states, Chidambaram said, "The controversy over FDI in retail is, in my view, unnecessary and unjustified".