LAHORE: Dr Qurat-ul-Ain Irfan is the vice president of Pacific Pharmaceuticals Limited and its quality assurance director. Pacific is perhaps the only pharmaceutical company in Pakistan that exports medicines to European Union. In an interview with The News she pointed out that Pakistan could be a force to reckon with in global pharmaceutical market by adhering to global quality standards. Here are excerpts from the interview.
Q. When you ask for adherence to quality do you mean that we lag behind in quality standards?
A. Do not take me wrong, we in Pakistan are producing high quality drugs and the regulator makes sure of the efficacy of drugs produced in the country. Many Pakistani pharmaceuticals are exporting drugs to numerous countries but we have been unable to export to lucrative markets like the United States, Canada, and the European Union. Indians have made great strides in these markets because they complied with the quality procedures required in these countries.
We have the honour of replacing many Indian pharmaceutical products in the European market as we complied with the additional quality requirements of the European Union. Currently we are exporting medicines to 25 countries that include Bangladesh, Belgium, England, Ethiopia, Germany, Ghana, Kazakhstan, Kenya, Kyrgyzstan, Maldives, Nepal, Netherlands, Nigeria, Saudi Arabia, Sri Lanka, Tanzania, Thailand, UAE, Uganda, Uzbekistan, Yemen, Vietnam, Hong Kong, Philippine and Azerbaijan. There are four major European Union countries among are clients.
Q. When there is no quality issue, why other pharmaceutical concerns cannot export to the EU and United States?
A. Every country, including Pakistan, takes utmost care before allowing medicines from other countries to enter their markets. You cannot export drugs to the United States unless your processes and premises are approved by their Federal Drug Agency. There is no FDA approved pharmaceutical concern in Pakistan. Similarly, in order to export to Europe, the pharmaceutical concern has to obtain Good Manufacturing Practices (GMP) certificate from the EU member country.
We have the distinction of having received GMP Compliance Certificate from Germany and it is the only Pakistani pharmaceutical company which has received this honour thrice; firstly in January 2004, second time in March 2007, and for the third time in June 2010. The certificate is awarded after the inspectors from EU visit the manufacturing facility, and approve all the processes from procurement, storage, manufacturing, quality assurance procedures, packing to marketing. Most of the domestic and even the multinational pharmaceutical concerns can get this certification if they are adhering to all the procedures required by them.
Q. They must be lacking in some aspect; can you point out some?
A. As I have already told you that these companies fully adhere to the practices notified by the drug regulatory authority of Pakistan and these measures are the same that are being practiced in India or Bangladesh. However, there are certain additional precautions taken by the regulators in developed economies that are not practiced in our region. This is the reason that very few companies in India are FDA or GMP certified.
One of the major hurdles in this regard is the absence of HVAC practices that ensures removal of all the foreign particles coming from air conditioners into the manufacturing facility. Ventilating or ventilation in HVAC is the process of exchanging or replacing air in any space to provide high indoor air quality, which involves temperature control, oxygen replenishment, and removal of moisture, odours, smoke, heat, dust, airborne bacteria, carbon dioxide, and other gases. Ventilation removes unpleasant smells and excessive moisture, introduces outside air, keeps interior building air circulating, and prevents stagnation of the interior air. This facility is absent in most of the companies. They can comply by establishing this facility. Some new companies are installing this facility.
Q. Do you have any problems with DRAP?
A. Our issues with the regulator are the same as faced by other pharmaceutical companies. Getting a fair price from the regulator is a major issue. Many life saving drugs have gone out of production as the price approved by the regulator was not commercially viable. Look at TB drugs. There were scores of companies manufacturing TB drugs two decades back. Now there are only five left and ours is one of them. Incidence of TB is on the rise, and the regulators must act now to give fair prices, or even these drugs will vanish. Thyroxin and Folic Acid are other examples of extremely low cost drugs vanishing from market. They are vital for human lives.
