Minister for National Health Services Saira Afzal Tarar on Friday said major reforms in drug regulation introduced over the last three years have led to an improved situation with regard to export of Pakistani pharmaceutical products.
Presiding over a pharmaceutical export seminar in Islamabad, the Minister said, “For the first time in the country’s history barcodes are being introduced for all medicine packs which will put Pakistan’s Pharma products in the list of countries where Pharma products are coded in line with international best practices and give a major boost to the country’s exports.”
“It will not only help in availability of quality drugs to ailing patients but will also eradicate the menace of spurious drugs and definitely will increase export of pharmaceutical products,” she said.
“We believe that National Pharmaceutical industry is the collateral partner with DRAP and Ministry of National Health Services, Regulations and Coordination (NHSR&C) in achieving its targets and effectively coping the major medicine needs of domestic as well as exporting quality products to about 40 countries. Although we inherited many problems but present government has addressed major hurdles and obstacles while coping with numerous other adverse challenges,” she said.
“I am also aware that industry is still facing some problems in some of the areas but DRAP and Ministry on NHSR&C is aware of these issues and hopefully these will be resolved on priority. As far as pharmaceutical exports are concern, I still recall that PPMA approached me about an year back with a long list of demands on the matters related to export and we held series of meeting with DRAP and these issue has been resolved,” the Minister said.
The Minister underscored that, “The requirement of prior order from importing country for grant of registration has been abolished. Chairman Registration Board has been authorized on various matters related to export.”
“Now DRAP has accorded around 1400 export registration approvals and now only about 80 registration applications for export purpose with shortcomings and most of these applications are pending on part of applicants for rectification,” she said.
She also said, “Decentralization and fast track processing of documents for exports has been introduced whereas Certificate of Pharmaceutical Products (CoPP) and Good Manufacturing Practice (GMP) Certificate are also issued to Pharmaceutical exporters.”
“CoPPs were previously delayed for months, now these cases are actively disposed within 10 days of completion of documents by applicant,” she said adding that export purpose GMP certificate validity has been extended up to 1 year from six months.
“DRAP, Lahore in particular and other offices as well has developed a robust automated system for clearance of imported materials (API, Packaging) where as import documents are cleared within 03 days’ time. It facilitates manufacturers, not only to meet domestic requirement but also to achieve export targets as well, mostly imported consignments are being cleared mostly within 48 hours from DRAP office,” the Minister said.
“Although, it was not your demand but on our own motion we decided to incentivize export, so to grant priority consideration for registration of drugs for local purposes as well for those manufacturers who are exporting their products above a certain value,” she said.
“DRAP’s Registration Board has decided to grant one molecule to a manufacturer as out of queue whose export for value of 100,000 US dollars and I have been informed that for this purpose, preliminary work has been completed and Registration Board will consider these products from forthcoming meeting,” Tarar stated.
She said, “Common Technical Document (CTD) is now standard worldwide for drug registration dossier format. Realizing the importance and growing demand of CTD as requirement for products registration in most part of world, we have also decided to adopt CTD format for filing of registration application of pharmaceutical products.”
The Minister said, “For enhancing capacity of DRAP and industry, DRAP in collaboration with international health partners like World Health Organization (WHO), United States Pharmacopeia (USP) has organized a series of workshops and training seminars during last two years for creating awareness and imparting knowledge by best human resource of the subject.”
“More than 500 technical personnel from Pharma industry as well as from DRAP have participated in these workshops and we do hope that it will help in developing their skills in this area that will improve quality of manufactured products,” she said.
She further said, “Another important area is moving towards WHO prequalification of Central Drug Laboratory, Karachi and after its accreditation, testing reports will have international acceptance aswell and will facilitate for export.”
“But, at the same time for enhancing export we together (DRAP and industry) need to further improve our GMP compliance as it is very shocking that pharmaceutical industry in Pakistan are not been recommended / approved by countries like Sudan, Ghana etc. our industry is required to urgently address the regulatory and GMP compliance up gradation for ultimate patient safety,” she said.
“DRAP has also started process for PIC/s membership and it will definitely improve level of GMP auditing by DRAP,” she said.
“Another fact is that almost all of our pharmaceutical companies, except few, are still exporting to lease or semi regulated / low priced market and are not able to enter into stringent regulated / high priced market. For this purpose, they need to improve facilities, expertise and practices on one hand and at same time they must perform intensive marketing campaigns to catch stringent and high value markets,” the Minister concluded.