Friday, December 5, 2008

Pharma package seen for Dec 10

The European Commission will present the much-delayed “pharma package” on December 10 at a press conference.

Ton van Liero, spokesman for Gunter Verheugen, European Commissioner for Enterprise and Industry, told me, “We foresee a press conference on Wednesday on the pharma package.”

Moreover, the Commission announced that the College of Commissioners (27 Commissioners) will be presented with it next Wednesday.

Commission spokesman Amadeu Altafaj Tardio told journalists: “On the agenda of the Commission meeting next Wednesday, will be a major pharmaceutical package. It has been subject of many draft directives, amendments, existing directives and Commission communications by Mr. (Gunter) Verheugen and various proposals and drafts and regulations, so the whole package that is for pharmaceutical industry.”

Earlier today addressing a joint press conference with health ministers from G7 countries (Canada, France, Germany, Italy, Japan, UK, US), Mexico and the World Health Organisation, European Health Commissioner Andrroulla Vassiiou also had expressed hope that the pharma package will come out soon.

The Commissioner was hosting Global Health Security Initiative (GHSI) to forge stronger global collaboration on health security.


Replying to a question about disagreements within the Commission, Commissioner Vassliou said, “It (Pharma package) is one of the most difficult packages and it is natural that all cabinets are very interested about it and there is a lot of discussion so that our purpose is to reach a final agreement on a package which will be in agreement with everybody,” adding, “I am hopeful that it will come up with something which will be satisfactory to everybody and useful to everybody.”

The European Commission has repeatedly delayed since October 21, the publishing draft regulations which could overhaul the pharmaceutical sector, amid rumours that divisions within the Commission are leading to the delays.


European Commissioner for Enterprise and Industry Gunter Verheugen had denied that his package of proposed new regulations for the pharmaceutical industry will be substantially altered despite its publication being delayed but APM understands there are disagreements within the College over such subjects as banning the repackaging of medicines, which is widely practiced by parallel traders.

The pharma industry has been pushing to ban repackaging of medicines saying it is the only way to stop trade in counterfeit products.

But supporters of parallel trade believe it could damage the legitimate practice of traders buying low-price drugs in markets such as Greece and selling them at a profit in other countries where they can command a higher price.

A report published recently on the website of the Commission's directorate general for Enterprise and Industry said that repackaging and relabelling medicines posed an inherent risk to patients but banning the practice would result in a dramatic reduction in the level of parallel trade and in the loss or redeployment of some 10,000 jobs across Europe.

The sources recently told me that a revamped package is now being prepared that will not ban repackaging. "Those proposals are history," said one.

This is in line with comments from a Commission spokesman earlier. "There is no ban foreseen on repackaging or relabelling ... Parallel trade is a legal economic activity in the European Union (and) the commission does not intend to change that."


But other measures in the pharmaceuticals package are also controversial, such as a proposal to allow companies to provide information on their drugs to patients, which some commentators believe is tantamount to permitting direct-to-consumer advertising.

The Association Internationale de la Mutualit√©, Health Action International (HAI) Europe and Medicines in Europe Forum today in an open letter to European Commission President Jose Manuel Barroso said: “The proposals on “information to patients” represent yet another tactic to delay generic competition by enabling the pharmaceutical companies to communicate directly to the public on their respective prescription-only medicines, thereby building "brand loyalty" and market share for their own originator products at the expense of affordable medicines for the public.”

Greg Perry, Director General, European Generic Medicines Association (EGA) had told me: "We understand the reason for the delay is due to lack of agreement on ITP (information to patients virtual network) proposal."

Perry said the EGA's main concern was now that the proposed legislation will not make it through this session of the European Parliament, particularly the pharmacovigilance package which is "a good proposal in terms of  improving patients safety, harmonisation and better regulation."

Thursday, December 4, 2008

Zardari faults on promises, terrorism crisis brews on

Author: Tejinder Singh,
3 December 2008 - Issue : 810

Will relations between India and Pakistan deteriorate again in the wake of Mumbai mayhem, just like when Pak militants attacked Indian Parliament in December 2001? President Asif Ali Zardari of Pakistan holds the key to the question but he must remember: "Half measures avail us nothing," a warning from a Western diplomat in Brussels on condition of anonymity.
If the first interview of President Zardari on CNN Larry King Live on December 2 is an indicator, then the Pakistani politician fell flat on his face as he even denied that the person arrested was a Pakistani, saying, "I very much doubt, Larry, that he's a Pakistani."

On the other hand, world Vox Populi is demanding accountability with people of India seething with anger on "live" TV while the Westerners are too shocked to react yet. Like many countries around the globe, this is an election year in India and the present incumbent Prime Minister Manmohan Singh's government can not afford to ignore public mood beyond a point, said a political commentator adding, "Restraint has a limit. That too in the face of mounting evidence of Lashkar-e- Taiba and al Qaeda in the attack on the country's iconic hotel, 105–year-old Taj in Mumbai."

"The siege of Taj, the adjoining Oberoi Trident hotel and Nariman House (a Jewish centre) lasted 48 hours. Live TV coverage delivered the threat of urban terrorism globally especially to every Indian home in real time," another Western political analyst told Tejinder Singh in Brussels on condition of anonymity.

President Zardari had earlier told Karan Thapar in the Devil's Advocate programme on CNN-IBN (Nov 29): "Let me assure you ... if any evidence points to any individual or group in my part of the country, I shall take the strictest of action in the light of the evidence and in front of the world."

Even as he was giving the interview "live," the TV channels were beaming the confessions of Lashkar terrorist Amjad Amir Kamaal, the lone survivor of the 10-man Lashkar-e-Taiba (LeT) fidayeen (suicide) squad which sieged Mumbai. Every media outlet in the world has by now carried his "song."


A class four drop out, Amjad Amir Kamaal hails from a small village of Faridkot in the Okara district of Pakistan's Punjab province. Top Lashkar commander Zakir-ur-Rehman allegedly promised to pay his family more than 2,500 Euro for participating in the fidayeen attack.

The sources familiar with the investigation point to the evidence: "There are the records of phone calls made by the fidayeen from a satellite phone, which was recovered after the attacks. These calls were made to LeT operations chief, who is known by code-names Muzammil, Yusuf and Abu Hurrera. Also to Zaki-ur-Rahman, whom the gang addressed as Chachu (Uncle), amongst others. There were at least three calls to 'Amir,' who frantically instructed the militants to take a hostage (at Nariman House) to 'make a point'."

Yusuf talked to his killer squad even during the bloodbath. The Sunday Express, Mumbai, reported (Nov 30) that each conversation lasted two to three minutes and the terrorists were given instructions in "Punjabi Hindi" with heavy use of military terminology. "Use cover fire," "use single burst fire," and "use your rounds sparingly" are some of Yusuf's instructions, for instance.

The sources divulged, "an intercept shows, on Nov 27 morning, when the Taj fight was on, his direction was: "Hotel mein aag laga do. Jab public bhaage gi, tum escape kar lena (burn the hotel down and in the pandemonium, you can escape)."

Calling it another give away proof, the reliable sources within the intelligence point to the GPS device that the Jehadis had used to navigate their way to Mumbai from Karachi's Azizabad is another give away, if President Zardari wants any more tell-tale proof.

There are also several other items, to wet his curiosity, like Namaz cap from a shop with the phone code of Multan, packet of wheat flour from a Karachi shop, an empty diesel can of a petrol filling station with a Karachi address, Made in Pakistan dental gel, medicam, Touchme shaving cream and Nestle milk packet, and Toilet paper packet of Zik brothers, Karachi.


Ahmad Rashid, one of Pakistan's sane voices, and an authority on al-Qaeda and Jihad, sees a pattern between the attack on Indian Parliament and Mumbai icons. In an interview to the Forbes Network 18, he said: "I think the attacks were strategically planned by al-Qaeda through LeT militants they train. It is trying to work out space for itself in the Federally Administered Tribal Areas, FATA. If tensions between India and Pakistan escalate, the (Pak) army will be moved to the Indian borders, as happened in 2002. This will buy a few months to al-Qaeda before the new US administration sends 20,000 more troops to Afghanistan."

This "relocation" plan is in the works, Geo News, a private Pak TV reported Nov 29 quoting a briefing of Pakistan's military and intelligence sources to a select group of journalists.

Geo News also reported (Nov 29) the military establishment decided not to send the ISI chief Lt Gen Shuja Pasha to India. Only a day earlier President Zardari and Prime Minister Yousaf Raza Gilani promised to Prime Minister Manmohan Singh that Pasha would visit Delhi as requested by him. Gilani's Press Secretary Zahid Bashir told a news agency: "Initially, Indian Prime Minister made a request to our PM that he should send the ISI chief to help in investigations and further intelligence sharing. The PM of Pakistan responded positively."

Nirupama Subramanian in The Hindu (Nov 30) also attributed the "roll back" to the army. "That there could be a change in the government's decision was evident when the military spokesman distanced the army from the announcement by the Prime Minister's office that ISI chief would go to India," she said in her despatch from Islamabad. The "new" decision was taken at 1.30 am on Saturday Nov 29 at a meeting of the troika – President, PM and army chief, Gen Ashfaq Parvez Kayani, according to The Nation of Lahore.

"Our hands are clean," Pakistan Foreign Minister Shah Mahmood Qureshi told a press conference in Islamabad on Nov 29 evening. "We have nothing to hide, we have nothing to be abashed of," he went on to say, and, like President Zardari, asked India to "come up with evidence to take strictest action."


Now that there is clinching evidence with India, and American intelligence, and counter-intelligence officials, as reported by the New York Times, are "convinced of the mounting evidence" of LeT responsibility for the brutal attack on Mumbai, Pakistan must come out of denial mode.

President Zardari must end talking his way out of trouble. And deliver on his promise. Not for avoiding trouble on the borders with India but to assert his authority as the head of the state, and to rein in his country's intelligence agency, ISI, which has been allowed to "go out- of –control" by his predecessors as a matter of deliberate state policy and as an insurance against American pressures.

Even Zardari could not deny it on the CNN Larry King Live show. On the question of the support of the Pakistani intelligence apparatus for militant movements, President said: "In the past, lots of mistakes have been made, I cannot deny that. But the present government does not support any such action."

A historic opportunity for not only Zardari, but also for Pakistan, to undo the past and to undo the designs of Islamists at home and thus abroad tarnishing the image and reputation of Pakistan on the global canvass. Instead Zardari is singing the old favourite song of Pakistani military asking for evidence, then denying it and the show goes on but the question is till when?

Tuesday, December 2, 2008

Lashkar-E-Taiba`s audacious siege of Mumbai

Author: Tejinder Singh,
1 December 2008 - Issue : 810, New Europe

The Indian sub-continent is up in flames again and the alleged hand of Lashkar-e-Taiba (LeT) with the blessings of al Qaeda is there to see in the siege of Mumbai's iconic hotels, the Taj and the Oberoi Trident, and the lone Jewish centre, the Nariman House among other targets.

Operation Black Tornado may have lasted more than forty hours trying to end the siege and to eliminate the dozen or so militants in their twenties but it made crystal clear to what great lengths the alleged LeT operatives and their handlers have gone to plan, coordinate and mount their attack on the symbols of resurgent India in its very financial capital.

Audacity? Yes, in a way.

So far the LeT has been content with IEDs and RDX induced blasts in crowded market places and railway stations to inflict maximum damage and to incite a flare up, though without success between the Hindus and Muslims.


The ongoing interrogation of alleged LeT operative Ismail alias Zakiruallah, a Punjabi from Faridkot in Pakistan, shows that the Murdike, Lahore headquartered outfit with pan-South Asia network and presence in some 18 countries, had fine tuned the Mumbai attack plan over several months.

According to sources familiar with the ongoing investigation, the final go ahead came recently at a conference in Murdike. On the conditions of anonymity, the sources confided that Prof Hafiz Saeed, the LeT founder with direct access to GHQ and to political masters launched a frontal verbal attack on India at the meeting and declared that India ought to be punished for its activities in Afghanistan. Ismail was arrested by the Mumbai police on Nov 26 night during the terror attacks.


The reliable sources told this journalist that Ismail divulged some chilling details of the attack by the hitherto unknown marine wing of the Lashkar –e-Taiba. They have been trained for months at Karachi, he told the police.

Another LeT operative, Ajmal Amir Kamal, who was nabbed as he was injured during the fighting at the Taj hotel, has corroborated Ismail evidence. Two other Pakistani nationals had also been held in the course of intense fighting on Nov 27 and their interrogation shows that at least 12 terrorists reached Mumbai; the key man has been identified as Imran Babbar.

According to details provided by sources close to interrogations, Lashkar operatives left Karachi in a merchant ship early on Wednesday, Nov 26. Late that night, the fidayeen left the ship in an India fishing trawler which was hijacked off Gujarat coast earlier, and rowed some 10 nautical miles to Mumbai's Gateway of India area. Once they reached close to the alighting point near Colaba, where heritage Taj hotel is located, they had lowered themselves into a smaller inflatable boat with a 20 HP engine and split into two groups for their raid.

Based on their interrogation, Mumbai police believe that the fidayeen unit of which Kamal was a part then split up into at least six groups, each focussing on a separate target: Mumbai's Nariman House, which is home to a large number of Israeli families and a Jewish prayer house; the Chhatrapati Shivaji Terminus rail station; the Cama hospital –a 500-bed hospital specialising in pre and postnatal care, the Girgaum seafront; and the Taj and Oberoi Trident hotels.


Police across Maharashtra, Uttar Pradesh and Kashmir working in close coordination have since traced the LeT plans to do something as daring as attacking Indian stock exchange in Mumbai in February itself. These reports were initially not given much credence though. Now after the Mumbai seize, the February interrogation of Uttar Pradesh resident Fahim Ahmed Ansar is being seen in a fresh light.

Ansari was arrested in February along with seven other suspects. A one-time activist of banned Students Islamic Movement of India (SIMI), he became a LeT man during a visit to Dubai in 2003. His front is a small enterprise of making paper-envelopes in Rampur in Uttar Pradesh.

Ansari has confessed to the police that he had carried out reconnaissance operations at the Oberoi Hotel — one of the targets in the Mumbai siege. The idea of strike at the Mumbai hotels and Bombay (Mumbai) stock exchange (BSE) was a sequel to a fidayeen attack on a police camp and training centre at Rampur on December 31, 2007.

Two specially-trained Pakistani nationals - Imran Shehzad from Bhimber in Pakistan-occupied Kashmir and Mohammad Farooq Bhatti from Gujranwala in Punjab carried out the attack though unsuccessfully. Both are being tried in an Uttar Pradesh court.

The sources told Tejinder Singh that Ansari disclosed that Imran and Bhatti have been asked to undertake the Mumbai mission. "I and my superiors entrusted the task of attacking the stock exchange to them. In all, we formed three assault teams," said he, the sources quoted from his interrogation report.

The Uttar Pradesh police records show Ansari returned to India through Kathmandu in late 2007. He stayed at the Sunlight Guest House in Mumbai from November 28 to December 10 before renting a room off Falkland Road. He became Samir Sheikh to secure a driving license, and enrolled himself as a student in a computer institute near the BSE.

All three BSE assault-team volunteers held Pakistani passports, which they hoped would enable them to escape by catching flights through Nepal. Shehzad carried a passport (number EK5149331), issued on March 14, 2007, while Bhatti used a passport with the number AW3177021, issued a day earlier. Ansari's Pakistani passport, BM 6809341, issued on November 1, 2007, bears the pseudonym Hammad Hassan.

Moreover the sources alleged that these fidayeens, like all other suicide squads of Lashkar-e-Taiba, have received special training to storm the gates of premises using grenades, following it up with indiscriminate assault rifle fire — tactics used with effect at Rampur police camp, and in dozens of similar operations in Jammu and Kashmir.


LeT has been active in India and most dastardly attacks in Indian cities in the past seven-eight years have been traced to LeT, which has re-invented itself in December 2001 to duck the American eyes as Jamaat-ud-Dawa (JuD). Global Jihad is the goal of LeT and its parent, MDI and its pamphlets preaching virtues of jihad have been found from Kashmir to Palestine, Chechnya, Kosovo, and Eriteria.

LeT, which is closely aligned with Pakistan's Inter Services Intelligence (ISI) agency, has the most extensive network in Pakistan with estimated 2, 200 cells across the country and Pakistan Occupied Kashmir (POK). Its cells have been discovered in more than 18 countries including US, UK, France and Bangladesh. According to sources in the Afghan intelligence the LeT is facilitating the movement of suicide operatives, fabricating improvised explosive devices, both independently and in conjunction with the Taliban.


Focus on westerners in the Mumbai siege suggests al-Qaeda is pulling strings of the LeT, which is known for its trade mark suicide attacks.

LeT has denied any involvement in the Mumbai siege. It has always denied any role in the fidayeen attacks in India over the past five-six years and has, in fact, been inventing outfits which are neither here nor there, like, for instance, the Indian Mujahideen, and Deccan Mujahideen. This is an ingenious attempt to create more plausible deniability for Islamabad. And also deflect attention of the United States away from its activities and thus avoid more pressure on Islamabad.

LeT's involvement is bound to cloud the US strategy for South Asia, as Jane Perlez says in his despatch from Islamabad to the New York Times on November 28 saying: "Reconciliation between India and Pakistan has emerged as a basic tenet in the approaches to foreign policy of President-elect Barack Obama, and the new leader of Central Command, Gen. David H. Petraeus. The point is to persuade Pakistan to focus less of its military effort on India, and more on the militants in its lawless tribal regions who are ripping at the soul of Pakistan."Put bluntly, the United States wants Pakistan to move its military's focus away from India to an all-out effort against the Taliban and their associates in Al Qaeda. This is to weaken the militants who are fiercely battling American and NATO forces in Afghanistan.


Hard-liners in and outside the Pakistan army and ISI, which is an extension of army, appear determined to foil the American plan. According to Western defence experts in Brussels, ISI is an agency dominated by officers, particularly in the middle level, and other ranks who subscribe to Islamist hard-line. It acts independent of the political executive with an agenda of its own in entire South Asia, and answerable only to the army headquarters. The agency also undermines the authority of President Asif Zardari, who is willing to reach out to India. He has already called for a visa-free travel between India and Pakistan. How much turf space he has even otherwise is doubtful since his plate is full – what with the meltdown of the economy and Islamists spreading their tentacles across the country.

Stratfor has put the issues in perspective. "The shape of the crisis will consist of demands that the Pakistanis take immediate steps to suppress Islamist radicals across the board, but particularly in Kashmir. New Delhi will demand that this action be immediate and public. This demand will come parallel to US demands for the same actions, and threats by incoming US President Barack Obama to force greater cooperation from Pakistan," it said in a commentary even as the Mumbai events were unfolding in their full terrorist fury.