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PPMA Circular regarding PIC case and the effect on Pharmaceutical exports from Pakistan

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PPMA Circular No. 016/2012PPMA-logo

February 10, 2012

To:        All Member Companies of PPMA

LETTER FOR THE EMBASSIES

Dear Members,

As you may already know regarding the unfortunate deaths reported at the Punjab Institute of Cardiology in the past few weeks.  We, the Pakistan Pharmaceutical Manufacturers’ Association (PPMA), the representative body of the Pakistan pharma industry have been shocked by this tragedy and have full sympathies with the affected families.  We have been having contacts and meetings with the authorities and also with the technical personnel in our member companies all over Pakistan.  The main purpose of the contacts and meetings was to

1. To ascertain the facts

2. To review the Quality Assurance/ Quality Control and cGMP guidelines and SOPs for validation.

These measures would be vital to prevent any further mishap of this nature.

Coming now to the facts; the samples were sent to the government labs as well as independent labs in the UK and Belgium.  So far we have seen reports of one batch from a particular company being contaminated.  However, we are unable to share the details as the matter is subjudice as the Supreme Court of Pakistan has taken Suo Moto notice of the entire matter.

We would like to mention here that due to lot of hype created by the media, panic has been created in the public’s mind that all locally produced medicines are spurious and sub-standard.  We started getting enquiries from the foreign buyers of our medicines, asking our manufacturers to clarify the matter.  In at least two cases, the orders have been cancelled by the foreign buyers.  We held press conference in Karachi, Lahore, and Islamabad where we stated the facts of the matter with a view of restraining the media not to spread the misinformation campaign as it would shatter the trust that the National pharma industry has built in the public over several decades, and would lead to its collapse, paving way for counterfeits to fill the vacuum that would be created in the market.  The National pharma industry is exporting to over 60 countries and the total exports are around USD 170 million.  40% of the leading brands of medicines marketed by MNCs in Pakistan are manufactured by National companies under contract manufacturing. This is reflective of the quality manufacturing of the National industry and the trust reposed in it.  We would like to mention that the exported drugs also undergo stringent quality control checks in their respective importing countries (case in point, Afghanistan where all batches are quarantined for 15 days by their Ministry of Health and then released for marketing after QC clearance), suggesting additional safeguards for the patients.

Incidence like this one, though unfortunate, happens even in developed markets and big MNCs have recalled contaminated batches, after deaths were reported.  We strongly feel that the entire industry’s image should not be damaged because of once in a lifetime incident like this one.

We hope that we have been able to give our viewpoint, and would like to assure you that the PPMA is doing whatever it can to prevent such an occurrence in the future.  Our members have already started the process of re-validation in their manufacturing process.  We seek your understanding and support in the matter.

Thanks and regards

Riaz Hussain

Executive Director/ Secretary General PPMA

c.c.      Mr. Tariq Ikram, Acting Chairman PPMA

           Mr. Muhammad Asad, Chairman PPMA (on leave)

PIC case gets a new twist | Efroze Chemicals ISOTAB was not prescribed to most of the victims – Mubashir Luqman

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Free medicine at Punjab Institute of Cardiology (PIC) becomes a death sentence. 130 plus deaths. Political mud-slinging. Conspiracy theories. Spurious accusations. Pakistan’s pharmaceutical industry in trouble. Catch up on the news first then read on.

Now that you are up-to-date on this bizarre story here’s a new twist! (Forward to around the 27 second mark)

What’s that now? Mubashir Luqman is on Dunya TV saying Efroze Chemical’s ISOTAB, the alleged killer drug, was not even prescribed to most of the PIC patients who died? Yes read that again. ISOTAB may not have been prescribed to those who died. Wait wasn’t the anti-malarial inadvertently added to ISOTAB conclusively responsible as the cause of death? Talha bin Ayub wrote a few days back in a guest blog on Teeth Maestro that things don’t add up medically and that a overdose from the anti-malarial can be reversed also.

We need to step back and really investigate this whole incident properly without political circuses or lynch mobs baying for blood. For the sake of the 130 plus who passed away. For the sake of the thousands that may die in the future if this entire episode is not used to structure the pharmaceutical industry, to build in safeguards, to strengthen our institutions, and to protect our people.

What do you think of this entire episode and these new developments?

From The Archives – The Coup In Pakistan

The below article written by Aly B was originally published on November 15, 1999 in the opinion section of Technician

 

Being a citizen of Pakistan, I am always in touch with what is happening in my homeland. The recent coup that toppled the government of Prime Minister Nawaz Sharif catapulted Pakistan to the front page of every major newspaper in the world. However, the event, which might seem like something major and unusual for Americans, came as no surprise to Pakistanis. For us it wasn’t a matter of if but when the Army would move in.

Since Pakistan’s independence in 1947, the Army has always played a major role in the political status quo in the country. Having been under military rule almost half the time, coups are no stranger to Pakistan. Even during civilian governments, especially in the last 10 years, the Army has had the role of kingmakers. Thus, for Pakistanis, military rule is nothing new. In 1988, the rule of the last dictator, General Zia-ul-Haq, ended when his plane was blown up. This brought about a restoration of “democracy” in Pakistan. With a literacy rate of less than 15%, and a tyrannical feudal system, Pakistan has never had a government of the people, by the people and for the people. There are two main political parties in Pakistan, namely the Pakistan Muslim League (PML), headed by Nawaz Sharif and the Pakistan People’s Party (PPP), headed by Benazir Bhutto. After the death of General Zia, Benazir Bhutto became the Prime Minister. However, she, along with her spouse Asif Zardari, used this term to steal from the coffers and to hoard cash abroad in Swiss Banks. Then, after her government was sacked by the President, Nawaz Sharif had his shot at screwing up the Pakistani economy and to build up his industrial empire. Once more, Bhutto came back in power after Sharif got dismissed for corruption, and instead of learning from her past mistakes continued to steer Pakistan on its course to bankruptcy. Once more, she was sacked on charges of corruption. This brought Sharif back into power again.

This time round, Sharif had a huge majority in the parliament and used this power to strip the President of his powers to dismiss governments, to humble the judiciary and to crack down on the press. His mismanagement of the economy and hoarding of personal wealth soon led to conditions ripe for a military takeover. In December 1998, Sharif started working on destroying the last remaining institution that had some integrity left. Due to this conflict, the then Chief of Army Staff (COAS), General Jehangir Karamat resigned from his position and Sharif picked General Pervez Musharraf to be the new COAS. In appointing Musharraf, Sharif bypassed the senior generals to ensure he would have someone who would remain loyal to him. However, when he began to play with the integrity of the army again, Musharraf quickly moved in his troops and toppled over the government. In order to legalize his move, Musharraf declared a state of emergency and suspended the constitution. However, he was careful to point out that this was not Martial Law and that the constitution had been put in abeyance temporarily.

This coup was widely criticized by the Western governments. The United States immediately called for a restoration of democracy threatening Pakistan with the usual sanctions, which incidentally were already in effect since Pakistan blasted its way into the nuclear club last summer. This call for restoration of democracy had an ulterior motive for the US government. Musharraf was a wild card for the US since he was less likely to be influenced by threats than a civilian government would have been. Also there was no assurance that Musharraf wouldn’t begin selling nuclear technology to Pakistan’s neighbors, Iran, and Afghanistan. Thus, it was in the best interests of the superiority of US to call for a restoration of democracy. However, following this initial criticism, the US has largely ignored the situation in Pakistan. The reason for this can be found in the statement of Milton Bearden, the former CIA chief in Sudan and Pakistan, to a sub-committee of the Senate Foreign Relations committee for South Asia.

“General Pervez Musharraf is a member of the last generation of Pakistani army officers who remember the military partnerships of the past with the US. He was trained at Fort Bragg and was an early member of the elite 19th Baloch Regiment, the Pakistani SSG, that trained jointly with US army special forces a decade ago. If we choose to engage Pakistan, even cautiously, Musharraf might be able to guide elements within Pakistani society away from the dangerous, fundamentalist path so many seem to be taking out of desperation.”

In other words, Musharraf is one of ours and we can utilize him to reestablish our control of the region again. Indeed, if the US is to curb Pakistan from siding with the more extremist countries out there, it has to maintain its hold over the country. Hence, the plea from Bearden to ease up on Pakistan. Cutting off aid to Pakistan would be like stomping on the fingers of someone hanging on the edge of a cliff.

For Pakistan, Musharraf may just be what the doctor ordered. A country that is rife with corruption and on the edge of bankruptcy, Pakistan needs some drastic measures to get it back on track. Doing this means purging the political parties from corrupt elements, taking measures to stabilize the economy and cleaning up the mess that has been left by the last few governments. Indeed the steps he has taken so far seem to be in the best interest of the country. Mr. Majyd Aziz, the chairman of the SITE Association of Industry (SITE is the largest Industrial Estate in Pakistan), endorsed Musharraf’s choice for the new finance chief, saying that he finds Mr. Shaukat Aziz (until recently a director of CitiBank) “a well respected person, who is not an armchair theorist, but someone who knows about economics and the fundamentals of business hands down. He is well known in the Western world for his business acumen and, if given a free hand, I believe he can deliver the goods.” On the new Foreign Minister, Mr. Abdus Sattar, he added: “He is a hawk, well experienced and an expert on nuclear matters. Being an ex-bureaucrat, he knows how to present his country’s views and will be able to project the country’s foreign policy with conviction and confidence.” (Source: Business Line, an Indian Financial Daily).

An editorial in the Dawn, a daily newspaper in Pakistan, expressed its confidence in the actions of the new Chief Executive of Pakistan but added a note of caution, by urging the military regime not to forget that “prolonged deviations from the democratic path have invariably led to more problems than have been solved. All the military regimes proved disastrous for Pakistan. The present military rulers must guard against the dangers of moving in the same direction.”

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