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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?

Pakistan: Traditional security challenges and response

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Majyd Aziz

A Guest Post by Majyd Aziz

PAKISTAN is on the global radar nearly every day. The world leaders, the universal media, and the international analysts and think-tanks have their daily dose of news and views from Pakistan. The country has never been so embroiled in safeguarding its sovereignty and its security than in these intense and severe times.

EXTERNAL THREATS

  • GLOBAL WAR ON TERROR:

PAKISTAN has, over the past some years, become the flashpoint as well as the most important country in the Global War on Terror. The Al-Qaeda obsession, the fear of Pakistan’s strategic assets falling into the hands of militants and extremists, the Western penchant for containing political Islam, the ever-increasing thirst for Middle Eastern oil, the fascination with mineral resources in Afghanistan, the domineering and influencing China factor, and the fixated concern for the safety and defense of Israel, have all resulted into an ominous scenario for the Islamic countries, with the paramount brunt being borne by Pakistan.

  • MUSLIM BATTLEGROUND:

PAKISTAN has, directly or thru outside influence, become one of those Muslim countries that is now a battleground where the armed forces of various countries have joined as a coalition to achieve the American great game objectives enumerated above. The oft-repeated American mantra of “Do More” has created a deep chasm between the Washington’s flawed Af-Pak policy and the pragmatism of the High Command in Rawalpindi.

  • GEO-POLITICAL LOCATION:

PAKISTAN is in an unenviable geo-politically strategic location and is the sole Islamic nuclear power. It also borders China, India, Iran, and Afghanistan and thus any vibrations from these countries are strongly experienced within the borders of this nation. Pakistan’s international commitments to the Coalition Forces has put a disastrous dent in the already-strapped financial resources of the country, although since 2002, the United States has pumped in over US$ 10 billion in security-related support and nearly US$ 4 billion in economic support.

  • PROXY WAR:

PAKISTAN has also, for many decades, become involved in a proxy war between the two major sects of Islam. This has primarily been supported by Saudi Arabia and Iran thru financial resources, thru ideological guidance, and thru tapping of the myopic approach of the clergy of both the sects in Pakistan. This has also intensified with the rise of militancy and extremism that has played havoc with the peaceful internal environment of Pakistan.

  • INDIAN INTERFERENCE:

PAKISTAN has also been embroiled in the never-ending militaristic, propagandistic, and diplomatic onslaught by the traditional nemesis India. The non-resolution of the Kashmir issue and the atrocities committed in the Valley by the Indian armed forces, New Delhi’s skewed mindset for blaming Pakistan for every event or problem faced by India even if these are concoctions or perpetrated by third forces, the blatant interference in Balochistan by Indian-supported militants, and the demonic influence of India in instigating Kabul against Pakistan have played a disastrous toll on the resources of Pakistan.

WAY FORWARD

PAKISTAN policymakers have to juggle various options in order to maintain its relationship with the Coalition Forces and at the same time, address the concerns of citizens who see Pakistan being a pawn in what a former American National Security Advisor, Zbigniew Brzezinski, referred to as “The Grand Chessboard”. At the present moment, there is an exploding anti-American sentiment and its negative consequences are directed towards the political and at times the military hierarchy. The army is the last bastion of assurance for the people and thus this must be further consolidated and strengthened. This requires that a proper approach should be initiated by the GHQ in which the denizens of Pakistan are taken into confidence and the ground realities are presented thru a correct media approach. It is imperative that the population be mobilized, it is important that the country’s strategic assets must be modernized and deployed within a given time frame, the nation’s political elements must have the stamina and critical mass to generate diplomatic and moral support for the armed forces, and more importantly, trade and industry must provide the needed back-up thru mobilization of financial resources, thru international image building, and thru private–public partnerships in areas crucial for the military to become a potent power. The Ministry of Foreign Affairs needs to be pro-active in economic diplomacy, in promoting a soft image of the country, and being aggressive in public international relations. This rethinking is essential in the countering the negative implications of external threats as well as removing the perception that Pakistan is subservient to Washington’s dictates.

INTERNAL THREATS

  • ISSUES:

PAKISTAN also suffers from the ignominy of being in a quagmire of internal problems that either are fallout from the effects of the external threats or are also self-created or self-generated due to non-resolution or diffidence to these issues in the past. These threats are as follows:

  • ECONOMIC FRAGILITY:

PAKISTAN has witnessed a severe economic downturn over the past couple of years. The nation has seen inflation inching towards the 20% mark while the State Bank of Pakistan is religiously increasing the discount rate in every Monetary Policy announcement. The unemployment lines are increasing daily while industrial investment has stagnated. Non-performing bank loans have breached the Rs 500 billion threshold, while the government keeps obtaining loans from commercial banks and the State Bank of Pakistan. The foreign exchange reserves are positive and at an all-time high, but at the same time, the external debt is over US$ 57 billion and growing. IMF has blocked the release of the next Tranche citing the inability of the government to undertake taxation reforms, specifically Reformed General Sales Tax (RGST).

  • NATIONAL NON-INTEGRATION:

PAKISTAN is currently facing the negative ramifications from various actions taken or ignored by successive governments especially in trying to achieve national integration. The hard stand taken by the Musharraf government in the Kalabagh Dam issue pitched Punjab against the three smaller Provinces. The Akber Bugti episode alienated a significant percentage of Balochis resulting in the influence of the Balochistan Liberation Army which itself became fodder for Indian and other countries’ manipulations and machinations. The renaming of NWFP as KPK brought Pakhtuns and non-Pakhtuns at loggerheads and the issue continues to create heartburns. Even the disastrous Lal Masjid imbroglio created rifts within the country. Recently, the exercise to amend the Law of Blasphemy has further vitiated the already traumatized nation. Punjab’s Governor became a fatal victim due to his vociferous views on this law. The obsession of various political parties to use the parochial card also aggravates the delicate environment. While PML (N) uses the Punjab Card, the PPP depends on flashing the Sindh Card to achieve desired objectives. Of course, the Raymond Davis problem is another gigantic headache for the government and other political parties.

  • SECTARIAN DIVERGENCE:

PAKISTAN also suffers from the menace of sectarian divide. The Sunni-Shia issue is exploited by inimical forces to create a disturbing law and order situation in the country. The Deobandi and Barelvi routinely fight over ideology and rituals and this has been intensified by suicide attacks on shrines and mosques. Ahmadis, Christians, and Hindus also face threats to their lives, property, and places of worship. Hindu families prefer migration to India rather than living in perpetual fear. Theocracy has managed to exert control over many aspects of daily lives of citizens. Unrestrained leeway is accorded to rabble-rousers who cash in on the misguided sentiments of people and use this to further their own agenda. The misuse of the Madrassahs has eroded the sanctity of these important learning institutions

  • ETHNIC POLARIZATION:

PAKISTAN is also facing suffocation due to ethnic distrust or ethnic hegemony. The emergence of ethnic-based political parties has further intensified this polarization. The country is still trying to figure out how many ethnic nationalities are dominant in the country. Turf wars between the land mafia or the drug mafia or even criminals are portrayed as ethnic clashes and this tainted colorization destroys civic peace and harmony. Karachi is a perennial hostage to the conflict created by the two major ethnic groups, each with its own vituperative agenda and blatant disregard for the consequences.

  • POLITICAL STABILITY:

PAKISTAN is endowed with juvenile politicians who are still unsure whether they have grown out of the influence of military rule since they still harbor the draconian tendencies and wield the proverbial machete on real or perceived political enemies. The concept of a democratic order is espoused ad nauseam and every action or statement against them is defined as an anti-democracy offensive. Opposition for the sake of opposition is the norm and the advent of talk shows on electronic media has further stoked up this instability and this infighting. Moral as well as material corruption has generally been the hallmark of a political government and this has ensued into a situation where institutions are brought to the precipice of disaster and where the country’s resources, whether these are financial, human, natural, infrastructure, or strategic are ravaged, plundered, and brazenly exploited.

WAY FORWARD

PAKISTAN is a country that in the past six decades has been subject to five or six wars, that has seen devastation due to floods and earthquakes, that has never reconciled to the fact that all its residents are Pakistanis firsts, that has seen political experimentation that has always boomeranged diabolically on the experimenters, and in the process, brought pain and sorrow to the citizens. What is imperative is a sincere effort to achieve reconciliation and integration that would usher in progress and prosperity, and would open new avenues of economic support and improvement in the quality of life for the citizens. What is essential is that intellectuals and social activists must ensure that people are motivated towards achieving a better and livable Pakistan rather than developing an apathetic mindset that gradually erodes every sense of nationalistic participation.

PAKISTAN has the largest percentage of youth in the world. 60% of the population is under 25 years of age. At this moment, the present, as well as the future, looks bleak for them. This negativism leads to resignation and that in turn impels them to drift towards anti-state elements who then use these young people as human cannonballs. The passion and energy of the youth have to be harnessed in a positive mode thru a visionary process that can be possible only when the policymakers themselves become immune to narrow-mindedness and parochial biases. The Armed Forces can play a prominent role in this respect. ISPR can initiate and finance motivational programs that can ignite the fire of patriotism, national integration, and challenges in the youth of today. The business community can contribute towards the development of the youth by supporting programs for entrepreneurship, for skills development, and for venture capitalism. The reason why focus should be on the youth is very logical. Nationalism and patriotism are forgotten words today. The youth of Pakistan must be steered on to the right path as they hold the key to the future prosperity of this motherland. Chinese President Hu Jintao, in his speech to the Chinese Parliament stated, “Let’s build a harmonious society in which the no-holds barred economic growth will be replaced with a more socially responsible form of development, with increased spending on education, healthcare and rural infrastructure”.

February 18, 2011

Majyd Aziz is a Karachi based Entrepreneur and a senior leader of the business community. He is a former Chairman of SITE Association of Industry, former President of Karachi Chamber of Commerce & Industry and has held posts on the board various public organizations and companies.

Views expresses in guest posts are the opinions of the author and may not necessarily reflect the opinions of DiscoMaulvi and From The Pulpit…

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