Asking the Indian government not to allow clinical trials for untested medicines, the apex court said a system must be put in place to protect the lives of people
The Supreme Court on Monday, said not to allow clinical trials for new drugs till a mechanism is put in place to monitor them and to protect the lives of people on which drugs are tested.
A Bench headed by Justice RM Lodha said that a system must be put in place to protect the lives of people and asked the Centre not to allow clinical trials for untested medicines.
The Centre also assured the apex court that it will not allow clinical trials for 162 drugs permitted by it earlier.
The Bench also asked the Centre to consider suggestions of various stakeholders in putting in place the mechanism to avoid any serious and adverse impact.
The Court had earlier said that clinical trials of untested drugs on humans require certain mandatory standards to be followed and had also directed the government to put in place a mechanism to monitor them.
It had directed the Centre to convene a meeting of Chief Secretaries or Health Secretaries of all the states to frame a law for regulation of clinical trials of drugs by multinational pharma companies.
Earlier, the apex court had said that uncontrolled clinical trial of drugs by multinational companies was creating havoc and slammed the Centre for failing to stop the rackets, which caused deaths.
Observing that the government has slipped into “deep slumber” in addressing this “menace”, the court had ordered that all drug trials will be done under the supervision of the Union Health Secretary.
In an affidavit, the Centre had admitted that 2,644 people died during clinical trials of 475 new drugs between 2005 to 2012.
“Serious adverse events of deaths during the clinical trials during the period were 2,644, out of which 80 deaths were found to be attributable to the clinical trials,” the affidavit had said.
“Around 11,972 serious adverse events (excluding death) were reported during the period from 1 January 2005 to 30 June 2012, out of which 506 events were found to be related to clinical trials,” the Centre had said.
The court was hearing a public interest litigation (PIL) 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.
The NGO had alleged that the clinical trials by several pharmaceutical companies were going on indiscriminately in various states.
According to the Tamil Nadu chief minister, linking DBT scheme for LPG customers to Aadhaar number without preparing adequate system would only lead to confusion
Reiterating Tamil Nadu government’s opposition to direct benefit transfer (DBT) scheme for consumers of liquefied petroleum gas (LPG) or cooking gas, J Jayalalithaa, the state chief minister, has urged Prime Minister Manmohan Singh to put on hold the roll-out of proposed second phase (Phase-II) of the project.
Jayalalitha, in a letter to the prime minister, said, “I strongly urge you to have a complete rethink on the proposed direct benefit transfer for LPG consumers and pending such a rethink, put on hold the proposed phase-II roll out”.
The Petroleum Ministry has announced that it has proposed to implement the second phase of direct benefit transfer scheme for LPG consumers in 235 districts across the country, including in 25 districts in Tamil Nadu from January 2014.
Referring to the recent Supreme Court verdict on the UID programme, the chief minister pointed out that so far against 6.74 crore eligible persons in Tamil Nadu, Aadhaar numbers have been issued only to 2.52 crore.
The Centre has made Aadhaar for DBT mandatory. Linking DBT scheme for LPG customers to the Aadhaar number without preparing the system adequately will only lead to confusion, she said.
According to reports, besides NSEL offices, residences of Jignesh Shah, Joseph Massey are also being searched in connection with the payment crisis at the Spot Exchange
The economic offences wing (EOW) of Mumbai police on Monday searched 184 places across 16 states, including residences of Jignesh Shah, chairman and managing director of Financial Technologies (India) Ltd (FTIL), and Joseph Massey, managing director and chief executive of MCX-SX. According to media reports, a first information report (FIR) has been filed against NSEL, its promoters, directors and defaulting brokers in MRA Marg Police Station.
The searches are being conducted in connection with the payments crisis at National Spot Exchange Ltd (NSEL), following the Mayaram Committee report, which implicated the Spot Exchange and its promoters, directors. There are 24 buyers and members who have to pay Rs5,600 crore to the Spot Exchange for settling dues of the investors.
In a statement, NSEL said, it had filed complaints with the EOW. "We understand that investors have also filed several complaints. Today, EOW officials initiated searches on the 24 NSEL borrowers' premises across the country. EOW has also searched NSEL premises today. We welcome any action by the government authorities. It is to help recover the money from the borrowers. NSEL and Financial Technologies Group will fully co-operate with the government authorities in these investigations and is open to any scrutiny to bring the actual culprits to book," the statement said.
According to Livemint, the searches are being conducted following submission of a preliminary enquiry (PE) case by EOW against NSEL, Shah and others in the payment crisis case.
"EoW personals also searched the 4th floor of Andheri based FT tower where NSEL offices are based. EoW has converted the complaint filed by the NSEL against its former MD and other senior management officials who have been removed from the duty following the NSEL fiasco and default by its borrowers," says a report from Business Standard.
The report says, "Police also converted the affidavit filed by the Anjani Sinha (former chief executive and managing director of NSEL) who had been removed from duty post the Exchange’s default. Sinha in his affidavit had alleged some of the officials had taken personal benefits and allowed the borrowers to take money."
Meanwhile, Sachin Pilot, minister for corporate affairs said he is expecting financial reports and other details from Registrar of Companies (RoC) on crisis-ridden NSEL's parent company FTIL group and other related entities in few weeks.
"We asked the department to send the report as quickly as possible. In few weeks time, (we) will have the report," he told reporters on the sidelines of an event organised by Confederation of Indian Industry (CII) on CSR.
The Ministry of Corporate Affairs (MCA) had previously asked RoC Mumbai to collect details of NSEL and other group entities. Besides, NSEL, FT group has promoted the country's top commodity bourse Multi Commodity Exchange (MCX), stock exchange MCX-SX, and also entities engaged in the business of clearing corporation and exchange technology solutions, among others.
Last week, Finance Minister P Chidambaram had said that NSEL was violating rules from the day one and the matter was being looked into by MCA, CBI and commodity markets regulator FMC, among others. "Whatever the Finance Ministry has asked us to do, we are doing it. We hope that we would be able to pin-point any non-compliance committed.
On 20 August 2013, the Exchange sacked Sinha, accusing him of having hushed up the fact that warehousing receipts (WRs) are not backed by physical stock of commodities.
It may be recalled that Shah and his team borrowed a lot of time by saying that it was imperative for all involved to be on the same side so that recovery of assets would give investors their money back.
NSEL, promoted by Shah-led Financial Technologies group, is already being probed by various other regulators and investigative agencies with regard to a Rs5,600-crore payment default and persistent violations of various regulations.