Tuesday, October 22, 2013
"No Clinical Trials of 157 NCEs till further order & 5 NCEs after proper mechanisms put in place” - Supreme Court
October 21st, New Delhi : 8th hearing of the writ petition filed by Swasthya Adhikar Manch took place today before the bench of the Supreme Court consisting of Justice R.M Lodha and Justice S.K. Singh. The case was filed in February, 2012 and the last hearing was held on 30th September, 2013.
The Hon’ble Supreme Court raised serious concerns over 162 clinical trials of Global Clinical Trial (GCT) including New Chemical Entities (NCEs) / New Molecule Entities (NMEs) out of which 157 were approved before 31st December 2012 and 5 between January to August 2013. In the Court it was admitted by Ministry of Health & Family Welfare (MOHFW) and representative of Drug controller General of India (DCGI) that 157 clinical trials were approved by DCGI on recommendations of New Drug Advisory Committee (NDAC) and without the approval of Apex and Technical Committee formed after order of Court dated 3rd January 2013. The Hon’ble Supreme Court have ordered GoI to reexamine 157 GCT including NCEs by Apex and Technical Committees. Therefore, now Apex and technical committee will have to evaluate these 157 clinical trials particularly in terms of - assessment of risk vs. benefits for patients, innovations to existing therapeutic options and benefits to medical needs of the country. It is only after the assessment of apex and technical committee that the question of commencement of 157 approval will be considered. In case of remaining 5 clinical trials which have been approved in 2013, the Hon’ble Supreme Court ordered MOHFW to conduct it only after ensuring proper mechanism & procedure to ensure safety of the patients along with audio-visual recording of participants maintaining principle of confidentially and preservation of documentation. The Hon’ble Supreme Court also raised its concern that there is no checks and balance in the frame work where investigators are paid by sponsors and ethics committees are part of hospital with absence of proper mechanism to ensure patients safety.
Mr. Sanjay Parikh Senior Counsel for Swasthya Adhikar Manch argued and highlighted the facts in relation to NCEs/NMEs and asked the government to come out with a position paper on how these NCEs/NMEs will be in public and national interest. The Hon’ble Supreme Court also then inquired that out of 162 trials, how many molecules are patented outside country and benefiting MNCs instead of development of new drug for which learned Additional Solicitor General was unable to respond. Mr. Parikh also pointed out contradictions in data given in affidavit filed by MOHFW dated 26th July 2013 wherein it was stated that only 26 GCT were approved while in current affidavit of 18th October 2013, it is stated that only 5 trials are approved after 3rd January 2013 by the apex and the technical committee.
The petitioner asked the MOHFW to provide details of 162 approved clinical trials- Name of molecule, indication, name of sponsor, protocol, sites, number of subjects, name of investigators and minutes of NDAC, apex and technical committee meetings. The petitioner also raised serious concerns about Ranjit Roy Chaudhry Expert Committee report on issues like conflict of interest etc. The Ranjit Roy Committee also was not able to explain benefits to India by allowing NCEs/NMEs testing within the country.
The petitioners have been raising the issue of how NCEs/NMEs are benefiting MNCs at the cost of human life in India. The next hearing is scheduled on 16th December 2013.
Amulya Nidhi (9425311547), Chinmay Mishra (9893278855) - SAM
N.D. Jayaprakash (9968014630) (email@example.com) - BGPSSS, Abdul Jabbar (9406511720) - BGPMUS
· Golden Jubilee edition to be played from November 7-10
· PGA Tour winner Michael Thompson and European Tour winner Robert Rock confirm participation
· Atwal, Randhawa and four other previous Indian winners lead Indian challenge
New Delhi, October 21: A star-studded field will tee off at the Delhi Golf Club to mark the Golden Jubilee of the historic Hero Indian Open on November 7. The event, which will be preceded by a Pro-Am on November 6, will carry a purse of US $ 1.25 million.
Returning to the place of its birth in 1964, the Hero Indian Open will once again see a plethora of champions and international stars line up for what will be a momentous occasion in Indian golf.
Though there is still more than two weeks for the tournament to happen, the list of early entries and confirmations indicate a very strong line-up including the likes of PGA Tour winner, American Michael Thompson, who achieved a breakthrough win at the Palm Beach event in Florida. Then there is multiple European Tour winner, Robert Rock, whose resume includes a stunning win over a field featuring Tiger Woods and Rory McIlroy at the 2012 Abu Dhabi Classic.
As is only befitting the 50th edition of the tournament will see a very strong Indian challenge, which blends youth with experience. Former Indian Open winners like Arjun Atwal, also the only Indian player to taste victory on the famed PGA Tour, returns to his National Open, as does Jyoti Randhawa, one of the only two players to win the Indian Open three times in their career – the other one is five-time British Open champion Peter Thomson, who also played a big role in helping establish the Indian Open in 1960s.
Four other Indian winners, C Muniyappa (2009), Vijay Kumar (2002), Feroze Ali (1998) and Ali Sher (1991 and 1993) will add to the charm of the historic staging.
Mr. Pawan Munjal, Managing Director & Chief Executive Officer, Hero MotoCorp Ltd., said, “Hero has been associated with golf since the time the game was at a nascent stage in the country. It is, therefore, a matter of immense delight to see this event celebrating its Golden Jubilee this year. Hero has been a partner in this glorious journey of golf and like always, we remain committed to the promotion of the game in India. I am looking forward to some memorable golf at this landmark edition of Hero Indian Open.”
Only seven Indians have won the National Open, of which the first PG Billoo Sethi (winner in 1965) passed away in 1982. The remaining six will be seen in action at the DGC this year.
While the past champions savour and relive their finest moments, the youth brigade led by four-time Asian Tour winner, Gaganjeet Bhullar, three-time Asian Tour winner, Anirban Lahiri and other winners like SSP Chowrasia, Shiv Kapur, Himmat Rai and Digvijay Singh will also fancy their chances at the legendary and challenging layout at the Delhi Golf Club.
Adding to their confidence will be the fact that Chowrasia, Lahiri and Digvijay have tasted international success at the DGC.
“The Asian Tour is proud to be associated with the 50th edition of the Hero Indian Open. The Asian Tour is also celebrating its 10th season in 2013 and on behalf of our talented players, I would like to congratulate the Hero Indian Open on its milestone,” said Asian Tour CEO Mike Kerr.
He further added, “The Hero Indian Open has been one of the longest running tournaments on our Schedule and the event has attracted many top golfers in India as well as from across the world. I’m confident the 2013 Hero Indian Open will be celebrated by the presence of the Asian Tour’s stellar stars including defending champion Thaworn.”
Gen. Bikram Singh, President, Indian Golf Union said, “It is a momentous occasion for the Indian Open Golf Championship that started it's journey in the year 1964 at this very venue, to be back again on the same course having traversed fifty long years in the company of some of the most illustrious golfers of their time. The pace was set by the likes of Peter Thomson who not only won the event three times here but later went on to win the Open Championship five times. I am sure that winning the Indian Open will remain an ambition with many golfers, especially in India, it being one of the most prestigious events on the Asian Tour. We are extremely grateful to all our stake holders who have ensured the successful conduct of the tournament over the years and especially
to the present title sponsors, Hero Moto Corp Ltd, for ensuring the grandeur of this year’s event against the historic setting of the Delhi Golf Club.”
Basking in his glory amidst the celebrations will be Ali Sher, who recalled, “I have great memories of that day, when I won the Indian Open at this very club. That changed my life and career. It’s is indeed a historic occasion to be playing in the 50th edition of the Hero Indian Open.”
Mr. Sunil Manocha, Chief Operating Officer of Nimbus Sport, added, “The Hero Indian Open is very close to the hearts of every Indian golfer and fans of the sport. As promoters of this historic event, we are extremely pleased with the line-up of star golfers from India and around the world who have confirmed participation for the fiftieth edition of the Hero Indian Open. I am confident of this edition of the tournament being nothing less than a jubilant celebration of golf in India.”
In another piece of great news for golf fans in the country, Ten Sports Network, will telecast live all the action straight from the fairways of the Delhi Golf Club on all four days.
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