The Tribune, Chandigarh, India

Compensation procedures for death, injury notified
Aditi Tandon/TNS

New Delhi, February 3
In a move that will go a long way in ensuring the safety of subjects who participate in clinical trials in India, the government has notified procedures whereby compensation will be awarded in case of death or injury suffered by persons participating in the trials.

Hitherto, there was no rule under the law to provide for compensation in case of serious adverse events or injuries to subjects in clinical trials.

The Drug Controller General of India (DCGI), the highest drug regulator, approves the conduct of clinical trials under the Drugs and Cosmetics Rules. But these rules have no procedures or even a mention of compensation to be given in case a participant in a trial suffers injury, disability or death.

The Ministry of Health has bridged this gap by issuing, for the first time, a notification under the Drugs and Cosmetics Rules which will make the DCGI the supreme authority in matters of compensation in such cases.

The pharma firms sponsoring the clinical trial will no longer have the power to recommend its own compensation amount in case of drug trial-related death or injury, as was the case till now.

Through another notification to be issued soon, the government will mandate advance registration of ethics committees of medical institutes conducting clinical trials.

At present, ethics committees are set up on the whims and fancies of the sponsors of trials and often the experts appointed to such committees are said to be favourable persons who recommend compensations in case any subject dies or suffers injury during the drug trial.

The complete arbitrariness that marks the clinical-trial sector in India has been a matter of debate for the past two years ever since Health Minister Ghulam Nabi Azad told Parliament that hundreds of people have died in such trials and very few have been compensated for such deaths.

According to the ministry, 2,242 persons have died in trials in the past five years. As against 668 who died in 2010, only 22 cases were compensated and that too meagerly with the value attached to a life by a pharma company being abysmally low, often as low as Rs 50,000.

All that is set to end. The new notification says that the sponsor of the trial, its investigator and the ethics committee of the medical institute conducting the trial will report any injury or death of a subject within 24 hours to the DCGI.

They will also submit independent reports to the DCGI on the causes of death and their own assessment.

The DCGI will then set up an independent inquiry committee to review the case and recommend compensation.

Based on this independent report, the DCGI will take the final call on the cause of purported injury or death stating whether it happened during the clinical trial or due to past medical ailment of the subject.

The DCGI will also then recommend the final compensation amount to be paid to the legal heirs of the subject whose consent for participation in the trial will be duly registered beforehand.

The new notification will apply to all such cases of clinical trial including bio-availability and bio-equivalence studies-related injuries or death occurring during clinical trial of drugs, including biological and medical devices covered under the Drugs and Cosmetics Act.

The categories of injuries have been laid down from minor harms (bruises or infected wounds) to major injuries (organ damage or temporary disability) to catastrophic injuries (permanent disability or death).

Clinical trials: Fresh Guidelines

The sponsor of the trial, its investigator and the ethics committee of the medical institute conducting the trial will report any injury or death of a subject within 24 hours to the Drug Controller General of India

They will also submit independent reports to the DCGI on the cause of death and their own assessment

The DCGI will set up an independent inquiry committee to review the case

The DCGI will recommend the final compensation amount to be paid to the legal heirs of the subject whose consent for participation in the trial will be duly registered beforehand

Posco land acquisition begins amid clashes

Paradip, February 3
After being halted for more than a year, land acquisition for the showpiece Rs 52,000-crore Posco steel plant in Odisha resumed today amid clashes between the police and protesters.

The acquisition process for the South Korean steel major's mega project amid tight security in Jagatsinghpur district was marked by claims and counter-claims on the violence following allegations of police crackdown on project opponents and injuries to some villagers due to lathicharge.

"Land acquisition process began in Gobindpur village in the proposed project site near Paradip. It will continue till all betel vineyards of the cultivators willing to hand over their land is completed," District Collector SK Mallick said.

Betel-vines and land of only those who had already given their consent are being acquired, Additional District Magistrate Surjit Das said.

Anti-Posco protesters indulged in stone throwing for sometime damaging at least five vehicles of the police and administration, sources said, adding police sealed all the entry points to Gobindapur.They also sealed the Gobindapur-Dhinkia road. Protesters from nearby areas like Ersama, Kujang and Jagatsinghpur were gathering in order to chalk out their strategy.

Leaders of Posco Pratirodh Sangram Samiti (PPSS), agitating against the project since 2005, alleged that police launched a crack down on villagers trying to resist entry of acquisition team into Gobindpur injuring about six people in lathicharge. Das, however, refuted the charge saying no force was used. — PTI

Vishwaroopam ban revoked, fans elated

Chennai, February 3
Clearing the way for screening of Kamal Haasan's Tamil movie "Vishwaroopam", the ban on it was lifted today, a day after the actor-director struck a compromise with Muslim groups to end the week long standoff.

In one fell swoop, District Collectors across the state revoked prohibitory orders under which the release was banned after Muslim outfits came out strongly against the mega budget movie, holding that some scenes in it hurt their sentiments. The prohibitory orders imposed under Section 144 have been lifted. The multi-lingual film, made in Tamil, Telugu and Hindi, was originally slated for release on January 11. — PTI

Jantar Mantar
Pawar presses the pause button
Anita Katyal

While press persons were taken unawares when NCP leader and Agriculture Minister Sharad Pawar told them last week that he will not contest the next Lok Sabha polls as he wanted to retire from electoral politics, his party colleagues were not particularly surprised. They said it has been abundantly clear for some time now that Pawar has no intention of working under Rahul Gandhi in the remote possibility that a Congress-led UPA comes to power for the third consecutive term in 2014 General Election. The announcement about his retirement plans was meant to convey the same to the Congress. It was also no coincidence that Pawar’s statement came shortly after the Congress elevated Rahul Gandhi as vice-president and virtually declared him as the party’s face in the 2014 General Election. However, Pawar’s colleagues were quick to clarify that this would have no impact on the Congress-NCP partnership either at the Centre or in Maharashtra.

Hooda-Selja ‘battle’ on

It is no secret that Haryana Chief Minister Bhupinder Singh Hooda and Social Justice and Empowerment Minister Kumari Selja are not on the best of terms. Evidence of their cold war keeps surfacing periodically. While Selja recently wrote to Congress president Sonia Gandhi to complain that the Haryana Government was not giving adequate funds to districts in her constituency Ambala, Hooda was quick to hit back. The Chief Minister did not invite her for the inauguration of the Surajkhand Mela although courtesy demands so as Selja is the only minister from Haryana in the Union Cabinet. Her name was conspicuous by its absence from the advertisements put out by the state government. However, Hooda made it a point to invite Avatar Singh Bhadana, the Congress Lok Sabha MP from Faridabad, and gave him a special mention in the ads. Hooda is probably still smarting as Selja had excluded his name from the invitations and publicity material of a cultural programme organised last year at Panchkula when she was the Culture Minister. In fact, Hooda was so miffed that he even wrote to Prime Minister Manmohan Singh to complain about the treatment meted out to him by Selja.

Raja and his Army

It is well known that officers from Upper Himachal Pradesh get preferential treatment from Chief Minister Virbhadra Singh who comes from the same region of the hill state. In fact, officers from the region started lobbying for plum postings soon after the veteran Congress leader took over the top job. A bulk of his senior staff members were from these areas during his earlier stint as CM and it is no different now. Whether it his personal staff in the CM’s office or at his residence, Virbhadra Singh has made his preferences quite clear as representation from the Lower Himachal Pradesh region has been kept to the bare minimum. TG Bali, who was the CM’s Principal Secretary in his last term, was promptly brought back as Adviser while VC Parka was named Principal Secretary. The list is endless.

India Art Fair
Exhibitors happy with response, sales
Nonika Singh
Tribune News Service

Visitors at the India Art Fair in New Delhi on Sunday. Tribune photo: Manas Ranjan Bhui

New Delhi, February 3
One of the many high points of the three-day mega art affair - the fifth edition of the India Art Fair - is, without a doubt, the presence of 40 international galleries from countries like Spain, Italy, France and Germany. On show were the works of many international artists - both masters and contemporary cutting-edge younger ones.

As the fair reached its climax on Sunday, a whole lot of them were all smiles - happy with the response, even happier with the sales. While entrant Gallery Scream, London, did great business from day one, other first timers like Bruno Gallery, Israel, not only got a whole lot of curious visitors interested in the cut-out steel works of David Gerstein, but also an Indian buyer ready to shell out Rs 25 lakh for his work titled Beauty Hunter.

Bart Van Zetten of Villa Del Arte Gallery, another gallery that came for the first time, too shared his enthusiasm both over the sales and the feedback. Sure he had done his homework, certainly he had spoken to galleries who had visited the fair before and tried to learn many lessons from those who hadn’t sold anything at the earlier editions of the fair.

As he has sold Jean Froncois Rauzier’s compelling work - actually a digital print mounted on aluminium encapsulated in print - for a Rs 20 lakh to an Indian buyer, he has reason to believe in the strength of the Indian market.

But all are not so upbeat. Die Gallery Germany, which has been to the fair previously, enumerates the difficulties in bringing art works to India. The prohibitive tax structure really acts as a damper, feel several international gallery owners.

Most vociferous was artist Jean Paul Guiragossian whose works were exhibited by Pi Art Works, Istanbul. Not only did he speak out his mind against the steep taxes - a cut in which he feels would lead to more sales and hence more revenue for the Indian Government - but he was also piqued by the way Custom authorities took his works out of the frames for checking. He lamented, “It could have damaged them.”

Even though he hasn’t sold much, he is contemplating coming again for he is simply overwhelmed by the energy of the viewers and their interesting queries. As he put it, “Not all joys are measured on the barometer of sales alone.”

A long-term relationship is what several galleries like Kalfayan Galleries from Greece are looking at. The Greek exhibitor has discovered a keen interest among Indians in Greek art.

If right now, more Indian collectors warm up to Indian artists like Sudarshan Shetty and Subodh Gupta - represented by international galleries - or legendary ones like Picasso and Dali, it hasn’t dismayed international galleries.

India is an exciting market. Even those whose sale records at the fair were negligible are ready to give the fair another chance. So it’s over to next time.

Armed chopper ‘Rudra’ gets operational clearance
Tribune News Service

New Delhi, February 3
Paving the way for the Indian Army to get its first lot of armed helicopters, the indigenously produced armed helicopter ‘Rudra’ has been accorded the initial operational clearance, marking an important milestone in military aviation history in the country.

This will result in induction of the first squadron of the choppers within the next few months. The Rudra is based on the platform of the advanced light helicopter (ALH) that is already in service in India. It has been code named ALH Mark IV and is produced by the Hindustan Aeronautics Limited (HAL). The helicopter derives its name from Rigvedic god for wind, storm and hunt.

The Centre for Military Airworthiness and Certification (CEMILAC), a body under the Ministry of Defence, presented the airworthiness certificate to the HAL today. “The occasion gives us the confidence and it is a proud moment for the country and boosts our indigenous activities”, said Dr RK Tyagi, chairman, HAL.

This will be the first time that the armed forces will be equipped with armed helicopters capable of fighting in the higher reaches of the Himalayas along the borders with China and parts of Pakistan.

The Army will get the first two squadrons of 10 armed helicopters. The induction of the Rudra will be an important milestone as the Indian inventory of armed helicopters, the Mi-35, currently has a flying ceiling of 10,000-12,000 feet. The Rudra, powered by a new Shakti engine that has been co-developed by French company Turbomeca, will fly up to an altitude of 20,000 feet. The Himalayas rise above this altitude along large parts of the India-China frontier.

The weapons on board the chopper will include a M6-21 20 mm gun and 70 mm rockets with a range of 8 km. These have been put through tests in hot, cold and humid climates. The chopper will also carry anti-tank guided missiles and the air-to-air-missiles, the first lot has been imported but will be produced here latter. The engine can carry a full weapon load to altitudes of 20,000 feet.

It is equipped with integrated sensors, weapons and electronic warfare suite using an upgraded version of the glass cockpit used in the Mk-III of the ALH. The cockpit avionics are among the best. The sensors include stabilised day and night cameras, infrared imaging, as well as laser ranging and designation.

The Electronic Warfare (EW) suite consists of missile approach warning system, laser and radar warning systems and automated sensors covering all envisaged threats. It has automatic dispensation of countermeasures like chaff and fare dispensing systems. The Army has contracted to buy 60 such helicopters. The final plan is to have an aviation brigade with each of the 13 corps of the Indian Army, the number of such armed choppers could go up to 130.

Each corps will have 10 (one squadron) armed helicopters, one squadron of reconnaissance helicopters and a squadron of utility helicopters.

Unplanned construction along highway causing landslides
Vijay Mohan/TNS

Chandigarh, February 3
The mushrooming of unplanned construction that is putting undue pressure on the soil and scant regard for adherence to technical specifications have been pinpointed as the reasons for a series of landslides along National Highway 21 in Himachal Pradesh. The highway connects Manali and the remote areas beyond with the rest of the country.

Post-disaster studies of landslides undertaken by the Geological Survey of India (GSI) over the past two years have revealed that blocking or modification of natural drainage lines on slopes without adequate provision for surface drainage of excess storm water during high-intensity rains prevalent in the area is a major reason for such occurrences.

The GSI report - that examined eight recent landslide sites between Swarghat near Bilaspur and Manali - states that in some areas like Swarghat, Mandi, Bhuntar, Raisan, Kullu and Manali, developmental activities like construction of buildings, road-cutting, embankments and fill structures modify natural slopes.

This results in blockage of surface drainage, undue loading of critical slopes and withdrawal of toe support, thereby making critical slopes vulnerable.

National Highway 21 is an important communication route. Besides being the lifeline to the districts of Kullu and Lahaul Spiti, it also has strategic implications as it provides an alternative road link to Ladakh via Manali and Keylong. It also sees heavy traffic during tourist seasons.

The landslides were primarily due to heavy precipitation, erosion of embankments along rivers and road-cutting. In one instance, it was found that a temple that had subsided during rains was built on a soil that had 92 per cent sand and hence, was not suitable for laying foundations.

The construction of causeways or culverts and improvement in drainage have been suggested by the GSI as proper drains can control the movement of surface water resulting in reduced seepage and porewater pressure at depth. Lined drainage, retaining wall, bio-engineering techniques, reforestation of degraded vegetation, proper land-use measures and creation of awareness among local population has also been recommended as short-term measures to mitigate landslide hazard in vulnerable areas.