February 10, 2012
To: All Member Companies of PPMA
LETTER FOR THE EMBASSIES
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
Executive Director/ Secretary General PPMA
c.c. Mr. Tariq Ikram, Acting Chairman PPMA
Mr. Muhammad Asad, Chairman PPMA (on leave)