We should become one voice against Mafias to promote good practices-Ayub Sheikh

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PPMA planning for Drugs Export worth 5 Billion US$ by 2025

We should become one voice against Mafias
to promote good practices-Ayub Sheikh

Pharma Industry should ensure availability of safe, effective
quality drugs at affordable prices - Dr. Mohammad Aslam

Drugs can become our 2nd biggest export after Textiles if
impediments are removed and Pharma Industry is
provided help and assistance- Saeed Allawala

Corporate culture being introduced in TDAP and
Good time for Pakistan is coming - S.M. Muneer

KARACHI: Drug Pricing Policy has been approved, it is transparent. If volume increases but profit margins are reduced, even then the overall profit will increase. All new molecules will be allowed average price in India and Bangladesh while Generics will get a  price of  30% less than the original molecule. However, there will be no compromise on Good Manufacturing Practices.  Time has come that we should become one voice against Mafias to promote good practices. This was stated by Mr. Ayub Sheikh Secretary Ministry of National Health Services, Regulation and coordination, Government of Pakistan while addressing a meeting of Pakistan Pharmaceutical Manufacturers Associaton (PPMA) related to its vision of Drugs Exports held here on May 1st 2015. Mr. S. M. Muneer Chairman of Trade Development Authority of Pakistan, Dr. Mohammad Aslam Chief of Drug Regulatory Authority of Pakistan and Acting Chairman of Federation of Pakistan Chamber of Commerce and Industry, Mr. Saeed Allawala Chairman PPMA, Mr. Zahid Saeed Chairman of FPCCI Standing Committee on Pharmaceuticals and Mr. Abdul Haseeb Khan were also present on this occasion.

Referring to the various issues listed by Mr. Saeed Allawala Chairman PPMA in his presentation Mr.Ayub Sheikh said that export growth, devolution issues, contract manufacturing is very important. He was happy to note that we have at least made a good beginning and have been able to find competent honest leadership for DRAP. However, various Mafias who have their own vested interests are very well entrenched and they are trying their best to create hurdles. There are good people in the Drug Regulatory Authority as well but there are others who have their own vested interests. To have a qualitative change in DRAP, we need quality people in Human Resource. Currently 192 positions are vacant in DRAP hence how it can work efficiently. When we decided to recruit them, we were told that there are no rules for that. We have now prepared those rules and eight senior executives are being selected from the open market on merit. Other posts will also be filled up soon. We are determined to induct quality people.  We have held quite a few meetings of the Policy Board and some of the forgotten issues have been resolved. We have received numerous complaints and we are not going to sit over them.  We will see each and every complaint. All the staff have been brought at one place hiring a government building and CCTV cameras have been installed to see who is coming to see  and meet whom so that there is some monitoring system in place.

 

Mr. Saeed Allawala Chairman PPMA presenting flower Bouquet to Dr. M. Aslam Chief of DRAP on left
and Mr. Ayub Sheikh Secretary Health on right at a meeting organized by PPMA at Karachi recently
in connection with its Vision of Drug Exports. Mr. S.M.Muneer Chief of TDAP is also seen in the picture.

As per the new Drug Pricing policy every year based on the CPI, the industry will be permitted to increase their drug prices as per the listed formula and just intimate us on our website. No formal approval is needed. We have taken important decisions regarding prices of new drugs as well as hardship cases and hopefully in the coming nine months time, all the hardship cases will be cleared as per the decision taken in the Policy Board meeting, he added. While there will be no compromise on GMP compliance, if any one is interested in  further enhancement of their quality control, we are going to have a higher category in which all such drug manufactures will be given Premium Price subject to the approval of the Policy Board. As demanded, a Task Force has been constituted headed by Mr. S.M.Muneer Chief of TDAP and with sincerity, we hope to overcome all the hurdles. I have asked Dr.Aslam chief of DRAP to fight with the Mafia; don’t be afraid of them as it will bring order.  As Muslims it is our firm belief that the Truth eventually wins Mr.Ayub Sheikh remarked.

Mr. S.M.Muneer Chief of TDAP in his address said that we have to find best people and throw out the bad ones. I have told my staff in TDAP that we are doing nothing. There are good and bad people in the bureaucracy as well as in the business. I often say that if these bureaucrats remove the steel from their neck, it will not only reduce the steel prices by almost 50% but also help improve the situation by facilitating things. These bureaucrats must understand that one day they have to retire and go to the next world. We all must have fear of God, do something good for this country and try to help people. I am all the time thinking how I can improve my exports but at present we have seen almost 6% reduction in our exports. Now we have introduced corporate culture in TDAP, we are making changes but it will take some time to have some effect. A few months back I was very much pessimistic but today I can say with authority that Good time for Pakistan is coming very soon. We have formed Export Committees and PPMAr Export Committee can have a few more members, prepare your case and send it to me so that we can study and then take it up with the concerned Ministers. We will ensure that you get your Refund soon. We have so far found out eight thousand files and another twenty five thousand such files may be laying there. We have started looking at those files which may include some of the files of Pharma industry. We hope to dispose off these cases soon. He called upon every one present on the occasion that let us do some good for Pakistan. He concluded his speech by narrating the following couplet:


Dr. Mohammad Aslam Chief of Drug Regulatory Authority of Pakistan (DRAP) speaking on the occasion said that we are trying to bring some reforms in the bureaucratic structure so that the pending issues are resolved quickly. We wish to pursue a transparent, open policy and ensure frankness between the Pharma industry and   the drug regulators. Patient safety, he opined, will remain the main focus. DRAP needs some improvements and so is the case with Pharma industry which also needs some improvement. He asked the Pharma industry to ensure the availability of safe, cost effective, quality drugs at affordable prices for the patients. Drug prices also has some political repercussions. India at present he said, exports drugs worth twenty billion US$. It is also a fact that drugs produced in Pakistan has better acceptance overseas as compared to drugs produced in India. We wish to adopt a futuristic approach while planning. The decision regarding annual increase in drug prices has been approved and we are open for further dialogue. As regards orphan drugs and hardship cases, these issues will be resolved within the next eight nine months. Health, OTC products and medical devices are now also being regulated and it is a difficult phase.

Continuing Dr. Aslam said that we recently invited a team of US Pharmacopeia with the collaboration of WHO to train people in assessment framework and implementation.   We plan  to have meetings at Karachi and Lahore after a meeting for the drug regulators on common technical documents in collaboration with the WHO. DRAP will extend all possible help and support to the Pharma industry but we must ensure GMP at an international level which will not only ensure increase in exports but also provide higher quality drugs to the local population. We all must remain patient focus and there won’t be any compromise on safety, efficacy and quality of drugs.

Earlier Mr. Saeed Allawala Chairman of PPMA in his presentation presented the PPMA Vision of having Drugs Export worth five billion US$ by 2025. Tracing the PPMA struggle in the past, he said that we have been trying for a policy change but failed so far. Our proposals were never accepted by the Government. If we take some decisions today, it will become a historic day and its results will be visible in the next four years. At present India with Drugs export worth twenty billion US$, Mr. Saeed Allawala said was the regional leader. Giving facts and figures, he said, the total world pharmaceutical market was  950 Billion US$ (Nine hundred fifty Billion) USA has the biggest share and accounts for  354 billion dollars followed by  China 82 Billion, Japan 82 Billion, Canada 20 Billion and Australia  13 billion US dollars. India has a drug market worth 15 billion US$ and twenty billion US$ drugs exports. After India, Turkey, Thailand, Malaysia and Bangladesh are the biggest players in the export market. Turkey and Thailand both have drugs export worth 0.5 billion US$ whereas Pakistan has drugs export worth just two hundred million dollars. Bangladesh Government has taken certain decisions to ease business for exports, hardships were removed and it is expected that Bangladesh might emerge as the second biggest drugs exporter from the region in the next few days.   We in PPMA, Mr. Saeed Allawala said has a dream to see that Pakistani Pharma Industry finds some place in the Drugs Export Market. However, due to government policies our export cost is higher. We are limited by our vision not by our abilities, he remarked. India, he said, is planning to have drugs export worth 45 billion US$ by 2020, Turkey is planning to have 23 Billion US$ drugs export while Thailand is aiming at drugs exports worth 9 billion US$. How they have been able to plan that is by signing MOUs with USFDA, WHO, Health Canada. Pakistan has the capability of becoming the second biggest player in the field of Drugs Exports in the region if the government gives some help and is supportive.  We should go out of the under developed market to the developed market. DRAP should become member of PIC, go for GMC certification, and simplify contract manufacturing to make it export friendly in support of the Pharma industry. Export requirements are kept pending for months and months. DRAP must establish some local good Reference Lab for Bioequivalence so that we do not have to go out of the country for this facility. DRAP and PPMA should have frequent interaction with specific focus on drugs exports. DRAP should share some GMP inspection cost besides extending support to the industry to qualify for FDA and EMEA.  A task force should be made which should report directly to the Prime Minister, he suggested. If we take some important decisions today, we won’t see its effect in a year or two but in the next four years. Our drugs export will grow if we enter the highly regulated markets in the West, he added.

Mr.Zahid Saeed Chairman of the Standing Committee on Pharmaceuticals in the FPCCI in his speech said that with 250 members, PPMA was the representative body of the drug manufacturers. We employ largest number of scientists and provide employment to over half a million people. However, we are facing some anomalies i.e. for us the Sales tax on packing materials becomes purchase tax as we cannot pass it on. Similarly finished drugs import has no taxes. Hotel industry and poultry has lowest duty but Pharma industry has to pay taxes even on import of machinery, equipment and instruments when it wishes to modernize its manufacturing facility. Then we are faced with income tax related issues. He urged the TDAP to release Pharma Company’s dues which are pending since long. He thanked the ANF for resolving the quota related issues, FIA for their help in fighting the menace of superiors drugs and DRAP for facilitating the Pharma industry but we need more facilitation, Mr. Zahid Saeed remarked.    

Mr. Rahim Janoo Acting Chairman of the FPCCI in his brief address said that now we have a business friendly government and under the leadership of Mr.S.M.Muneer we will get our problems resolved soon. When I took over the leadership of our group which is of Rice Exporters, our export was worth 300m US$ and during the last three years we have increased it to three Billion US$. Mr. Haseeb Khan opined that Health should also be included in DRAP. Impediments are common; they should be removed as they are hurting our exports. It will also safeguard the local industry. He also asked for induction of competent people in DRAP on Merit. We need a committee of just three people i.e. S.M.Muneer, Finance Minister and the Prime Minister and all the issues can be resolved, he remarked.

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