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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?

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