MINUTES OF THE 1ST MEETING OF THE CENTRAL EXECUTIVE COMMITTEE (CEC) OF PPMA FOR THE TERM 2016-17 HELD ON 3RD NOVEMBER, 2016 AT PEARL CONTINENTAL HOTEL, KARACHI.
The 1st Meeting of the Central Executive Committee (CEC) of PPMA was held on 3rd November, 2016 at Emerald Room, Pearl Continental, Hotel, Karachi.
The meeting was presided over by Dr. Shaiekh Kaiser Waheed, Chairman PPMA and following Members were attended:-
Mr. Ijaz A. Siddiqi Sr. Vice-Chairman PPMA Himont Pharmaceutical
Mr. Nadeem Ahmed Chandna Member CEC PPMA Elko Organization
Mr. Shuja Malik Member CEC PPMA UDL Pharma
Ch. Israr Sharif Member CEC PPMA Genix Pharma
Mr. Naveed N. Hakim Member CEC PPMA Helix Pharma
Mr. Ilyas Nainitalwala Member CEC PPMA Epharm Laboratories
Mr. Ehsan Awan Member CEC PPMA Nawan Laboratories
Mr. Haroon Qassim Member CEC PPMA PharmEvo
Mr. Tauqeer ul Haq Member CEC PPMA Sante
Ms. Mahvash Tariq Siddiqi Member CEC PPMA Epla Laboratories
Mr. Nadeem Zafar Member CEC PPMA Friends Pharma
Mr. Khawaja Shahzeb Akram Member CEC PPMA Mass Pharma
Mian Yasir Liaqat Ali Member CEC PPMA FYNK Pharmaceutical
Mr. Tahir Latif Member CEC PPMA Aventek Pharma
Mr. Zahir Saeed Former Chairman PPMA Indus Pharma
Mian Asad Shuja ur Rehman Former Chairman PPMA The Schazoo Pharmaceutical
Mr. Ansar Farooq Medizan Labs.
Mr. Najeeb ur Rehman Ray Pharma
Mr. Waqas Ali Khan Medicaids Pakistan
The proceedings of the meeting started with Recitation of the Holy Quran by Dr. Shaiekh Kaiser Waheed, Chairman PPMA.
Dr. Shaiekh Kaiser Waheed welcomed all the participants and thanks them for participating in the meeting and informed that he joined PPMA in 2002 and since then observed that no one is ready to accept pharma industry as an industry. Perception of all main stake holders i.e. Public, Parliamentarian and Press are totally negative towards the industry and result lots of pressure come on the regulators and they take wrong decisions.
He said that industry is doing tremendous job for the public and for the country and time is come to build positive image of the industry. Mandate of CEC is to deal with the regulators for the benefit of the industry and this year we will deal with them strongly to resolve our burning issues. He requested to the house that we should start efforts of image building of the industry independently as well and should print public messages on our literatures and every possible place which definitely creates positive image of the industry.
After a brief speech of Chairman PPMA the proceedings started with agenda item No. 1.
AGENDA ITEM NO.1:
CONFIRMATION OF THE MINUTES OF 9TH MEETING OF CEC FOR THE TERM 2015-16 HELD ON 22ND SEPTEMBER, 2016 AT LAHORE.
Minutes of last meeting approved by the house and
Proposed by Mr. Zahid Saeed
Seconded by Mr. Nadeem Zafar
AGENDA ITEM NO. 2:
CO-OPT OF 4 NEW CEC MEMBERS, TWO FROM NORTH ZONE AND TWO FROM SOUTH ZONE AS APPROVED IN THE 51ST AGM OF PPMA HELD ON 8TH OCTOBER, 2016 AT KARACHI.
As, this issue is already discussed and approved in the 51st AGM held on 8th November, 2016 so the house is approved to co-opt the following four members in the CEC for the term 2016-17:
From South Zone: Mr. Najeeb ur Rehman, Ray Pharma and Mr. Waqas Ali Khan, Medicaids Pakistan.
From North Zone: Dr. Riaz Ahmed, Sharooq Pharmaceutical and Mr. Ansar Farooq, Medizan Laboratories.
It was decided to get amendment in the Memorandum and Article of the Association to increase numbers of CEC from 22 to 26 through Bilwani & Co.
Agenda Item No. 3
TO FINALIZE THE SUBJECT COMMITTEES OF PPMA FOR THE TERM 2016-17:
Before finalize the subject committees the house discussed on the following issues:
1. Medical Device: Mr. Zahid Saeed informed that this is very serious issue and PPMA should make strong technical dossier with the help of technical committee and submit into DRAP before DRAP make any decision which could be negative for the industry. He further said that so many members of PPMA are interested of manufacturing of Neutraceutical Products and Medical Device, so the matter should take up seriously as this is the only way to enter Europe without inspection and if we want to take first step to our industry into regulated market we can enter through medical devices and not through medicines. He further informed that all Vitamins and all Minerals considered as Neutraceuticals in European Market and we can enter without registrations and no need of Vitamin Registration.
2. Neutraceutical / OTC Products: Mr. Shahzeb Akram said that CEC should take this issue very seriously and said that we should allow to enroll those manufacturers those have form “6” as member of PPMA. After brief discussion it was decided to make committee comprising 3 members each zone to discuss the issue and to make strong guideline as DRAP is calling PPMA to discuss on this issue. Mr. Ehsan Awan said that no Presentation of PPMA in OTC and Medical Device meetings and PPMA should take appropriate action to include PPMA in OTC and Medical Device meetings.
- Psychotropic: It was informed that in DRAP the issue of SOP of Psychotropic is being discussed and any wrong decision can be taken by DRAP in this regard so PPMA should act promptly to resolve the issue.Mian Asad Shuja ur Rehman informed that Secretary Narcotic is a good person and ready to change the SOP of Psychotropic but seeking proposal from DRAP in this regard.After the above deliberations, Dr. Shaiekh Kaiser Waheed come to the agenda point of finalizing the subject committees and informed the house that he deleted some subject committees which are not functionalized and merge a few committees with the consensus of the CEC and reduced from 40 to 23 and requested the house to read and discussed and if found satisfactory the house should approved the changes in the subject committees for the term 2016-17 and for onward.
The house read and discussed the changes in the subject committees and after some deliberation, the changes were approved.
The 23 subject committees were finalized one by one and mentioned below:
|ALLOCATION OF PPMA COMMITTEES 2016-17|
|S NO.||SUB-COMMITTEE NAME||NAME OF PERSON||STATUS||NAME OF COMPANY|
|1||ADMINISTRATION||Dr. Shaiekh Kaiser Waheed||Chairman||Medisure Laboratories Pakistan||SOUTH|
|2||BASIC MANUFACTURING||Mr. Mustafa||Chairman||Saakh Pharma||SOUTH|
|Mr. Ehtisham ul Haq||Co-Chairman||Alpha Pharma||NORTH|
|3||FBR (Included Customs / Import / Taxation)||Mr. Hanif Sattar||Chairman||Otsuka Pakistan||SOUTH|
|Mr. Haseeb Khan||Co-Chairman||Harmann Pharmaceuticals||NORTH|
|4||EXPORT||Mr. Hamid Raza||Chairman||Neutro. Pharma||NORTH|
|Mr. Saboor Ahmed||Co-Chairman||Karach Chemical Ind.||SOUTH|
|5||FINANCE||Mr. Tauqeer ul Haq||Chairman||Sante (Pvt) Ltd.||SOUTH|
|Dr. Tahir Azam||Co-Chairman||Mega Pharmaceuticals||NORTH|
|6||TECHNICAL / GMP ENVIRONMENT||Mr. Arshad Rahim Khan||Chairman||OBS Pharmaceuticals||SOUTH|
|(Included: Human Resource / Ethics )||Mr. Arif Bilal||Co-Chairman||CSH Pharmaceutical||NORTH|
|7||LEGAL AFFAIRS||Mian Shafi||Chairman||Murfy Pharmaceutical||NORTH|
|Zahid Saeed||Co-Chairman||Indus Pharma||SOUTH|
|8||PRICING/DPC||Mian Zaka ur Rehman||Chairman||Schazoo Zaka Pharmaceuticals||NORTH|
|Mr. Sohail Mateen||Co-Chairman||GSK||SOUTH|
|9||PROVINCIAL AFFAIRS – BOLOCHISTAN||Mr. Asif Akhai||Akhai Pharmaceutical||SOUTH|
|PROVINCIAL AFFAIRS – PUNJAB||Mr. Shahzeb Akram||Mass Pharma||NORTH|
|PROVINCIAL AFFAIRS – Sindh||SOUTH|
|10||REGULATORY AFFARIS||Mr. Abu Zar Faizi||Chairman||Genome Pharmaceuticals||NORTH|
|Ms. Mahvash Tariq Siddiqi||Co-Chairman||Epla Laboratories||SOUTH|
|11||MEDICAL DEVICES i/o SURGICAL GOODS||Mian Asad Shuja ur Rehman||Chairman||The Schazoo Pharmaceuticals||NORTH|
|Mr. Zahid Saeed||Co-Chairman||Indus Pharma||SOUTH|
|12||VETERINARY||Dr. Saleem Iqbal||Chairman||Unison Pharma||NORTH|
|Mr. Ehsan Awan||Co-Chairman||Nawan Labortories||SOUTH|
|13||WTO/PATENT/TRADE WORK||Mr. M. Haroon Qassim||Chairman||PharmEvo||SOUTH|
|Mian Zaka ur Rehman||Co-Chairman||Schazoo Zaka Pharmaceuticals||NORTH|
|14||REPRESENTATIVE ON REGISTRATION BOARD||Mr. Zahid Saeed / Mr. Ehsan Awan||Indus Pharma / Nawan Labs.||SOUTH|
|Dr. Riaz Ahmed / Mr. Khalid Munir||Sharooq Pharma / Trigon Pharma||NORTH|
|15||LICENSING||Ms. Mahvash Tariq / Mr. Tauqeer||Chairman||Epla labs. Sante (Pvt) Ltd.||SOUTH|
|Mr. Arshad Mehmood / Mr. Pervaiz||Co-Chairman||Welwrd Pharma / Orta Labs.||NORTH|
|16||PSYCHOTROPIC||Mian Asad Shuja||Chairman||The Schazoo Pharmaceuticals||NORTH|
|Mr. Zahid Saeed||Co-Chairman||Indus Pharma||SOUTH|
|17||PQCB||Dr. Kaiser Waheed||Chairman||Medisure Laboratories||SOUTH|
|MR. Shafiq Abbasi||Co-Chairman||Novamed Pharmaceuticals||NORTH|
|18||FPCCI||Mr. Shahzeb Akram||CEC||Mass Pharmaceuticals||NORTH|
|Mr. Abdul Haseeb Khan||Gen. Body||Brookes Pharmaceuticals||SOUTH|
|19||PR COMMITTEE / Media Committee||Mr. Ilyas Nainitalwala||Co-Chairman||Epharm Laboratories||SOUTH|
|Mr. Uzair Nagra||Chairman||Medisearch Pharmacal||NORTH|
|Mr. M. Hamza Ijaz||Co-Chairman||Pak Hem Pharma||NORTH|
|21||OTC / Neutraceutical||Chairman||SOUTH|
|Mr. Ijaz A. Siddiq / Mr. Shahzeb Akram||Co-Chairman||Himont Pharmaceuticals / Mass Pharma||NORTH|
Agenda Item No. 4
INTERVIEW OF SECRETARY GENERAL OF PPMA.
Dr. Shaiekh Kaiser Waheed informed the house that he along with Mr. Ijaz A. Siddiqi went to Islamabad and searched a suitable office for PPMA Center in Islamabad but due to various reasons unable to find new office and then went to existing office of PPMA Center situated in I-8/2 and found it satisfactory as it has ample space and furnished with a reasonable rent. Therefore, it was decided to continue with the existing office of PPMA Center.
He further informed that he took interviews of some candidates and found suitable to Mr. Nawaz Ahmed for the post of Secretary General of PPMA. He gave some introduction of Mr. Nawaz Ahmed and called him in front of the august house for interview. Mr. Nawaz Ahmed gave his introduction and assured that he will do his level best to justify his selection as Secretary General of PPMA.
After interview of Mr. Nawaz Ahmed the house discussed in detail about the job responsibility of Mr. Nawaz Ahmed and decided to form a committee comprising Mr. M. Haroon Qassim and Miaz Zaka ur Rehman to make TOR’s of the new Secretary General of PPMA. The house approved the appointment of Mr. Nawaz Ahmed as Secretary General of PPMA on the basis of contract of one year.
At this point Dr. Shaiekh Kaiser Waheed informed the house that as the previous CEC decided to terminate Mr. Asif Khan Afridi, Assistant Secretary, and Mr. Asif Saleem Bhatti, Office Assistant of PPMA Center and requested the house to approve the full and final payment of both above persons which is given below:
Mr. Asif Khan Afridi, Rs.74,288/- (including Salary of August, 2016, Leave Encashment of 2015 and Bonus for 8 Months of 2016).
Mr. Asif Saleem Bhatti, Rs.37,980/- (including Salary of August, 2016, Leave Encashment of 2015 and Bonus for 8 Months of 2016).
The house unanimously approved the above mentioned amount as full and final payments of Mr. Asif Khan Afride and Mr. Asif Saleem Bhatti.
Agenda Item No. 5
Briefing on 262nd Meeting of DRB held on 20th & 21st October, 2016:
Mr. Ehsan Awan who was attended the 262nd Meeting of DRB gave report which is mentioned hereunder:
SUB: REPORT OF 262nd DRB MEETING HELD ON 20th and 21st OCTOBER 2016 AT ISLAMABAD.
I attended 262nd DRB meeting on both days along with Mr. Shafiq Abbasi (NORTH ZONE)
The meeting started promptly with recitation of holy Quran at T.F Complex, Board Room, Islamabad at 9.30 am.
1) All New Board Members have been constituted for the Registration Board
2) It was the first meeting after the constitution of NEW BOARD MEMBERS, Secretary Registration Board Dr Obaidullah gave a presentation over Functions and Responsibilities of DRAP Registration Directorate highlighting the movement of Registration Dossiers and Regulatory Approvals Process.
3) I recommended to the BOARD that since its their first time attending the BOARD MEETING; PPMA would also like to give presentation to BOARD members highlighting the GOOD work Pharmaceutical Industry has been engaged since its inception.
4) SOP’s of Export Dossiers and Renewal need to be re-visited. Dr Obaidulah showed his concern the PPMA has not so far given their comments on SOP’s of Drug Renewal .
5) Renewal of Drug Registration has been made cumbersome for which PPMA needs to negotiate with DRAP over submission of unneeded documents for e.g the last manufacturing batch record & last ADC attested import documents. I suggest that many products are for tender or export business and sometimes even in 5 years the products are not manufactured. SOP of RENEWAL should be re-visited.
6) Delegation of Work and Power of Board to Chairman on matters Highlighted in Agenda which were given before in earlier meetings were re-validated.
7) New Committees to be formed For ON-SITE INSPECTION OF STABILITY STUDIES FOR NCE’S.
8) Cases of SOFOSBUVIR were approved where committee has visited the Manufacturing premises and recommended approval and few were rejected where documents could not be verified.
9) ROUTINE CASES:
- Dossiers where documents were complete were approved and others were deferred
10) QA PERSONAL HEARING CASES
Old pending cases of Firms QA cases were called for personal hearing.
During the briefing, it was decided to send letter to Drug Registration Board having requested for comprehensive presentation by PPMA in the next DRB Meeting.
Members also showed reservation and requested to Chairman PPMA that COPP and CGMP Certificates should be issued by Local ADC’s and also informed that fee of each COPP Certificate is being charged Rs.5,000/- and this exorbitant and seeking PPMA efforts to waive this fee or minimize it.
It was also informed that FID Inspectors came to inspect for each case which is not necessary and requested to Chairman PPMA that he should do the needful to waive these inspections.
Dr. Shaiekh Kaiser Waheed requested to Mr. Ehsan Awan to make a draft of the issues those are faced by the member companies of PPMA and issues which are to be addressed by PPMA those were discussed in the 262nd DRB meeting.
Agenda Item No. 6
RENEWAL OF PPMA LICENSE OF DGTO (VALID UPTO 3RD NOVEMBER, 2016)
Dr. Shaiekh Kaiser Waheed informed that DGTO License of PPMA is being expired on 3rd November, 2016 and further said that we have to renew our license and the assignment is given to Bilwani & Co.
Mr. M. Haroon Qassim said that this year, PPMA has a plan to hold 3rd Pharma Summit in Lahore probably in April or May, 2017. Dr. Shaiekh Kaiser Waheed informed that the program consist one and half day, first organize a Seminar and next day host 3rd Pharma Summit. In this regard a committee is formed comprising the following members:
Mr. Ijaz A. Siddiqi and Dr. Tahir Azam from North Zone and
Mr. M. Haroon Qassim from South Zone
It was also decided that the above committee will book the hotel and appoint event management for the pharma summit.
Madam Mahvash Tariq Siddiqi pointed out that as FBR is being sent notices to South Zone Members in this regard she met with Mr. Haroon dugal and as per opinion of Mr. Haoon Dugal, FBR is crossing its ambit. She further said that she will send draft which every recipient of FBR notice should send FBR to circulate all members. Secondly she informed that today news appeared in different news papers that Competition Commission send notice to Pharma Bureau regarding price increase and ask the Chairman PPMA could PPMA also hit by Competition Commission.
Dr. Shaiekh Kaiser Waheed informed the house that he asked opinion of Mr. Haroon Dugal regarding PALLETS BEING CONSIDERED AS FINISHED IMPORTED DURG that whether we go to court for obtaining direction to DRAP. He further said that as I received opinion from Mr. Haroon Dugal same will be circulate to CEC.
It was also informed that due to various reasons and specially miss use of PPMA Official WhatsApp Group is abandoned and now onward there is no official Whatsapp Group of PPMA. Only CEC Members WhatsApp Group is active and managed by Dr. Shaiekh Kaiser Waheed himself.
Mr. Ansar Farooq pointed out that still waiting for the minutes of last five DPC meetings. Dr. Shaiekh Kaiser Waheed replied that we are already working on this issue and sent four reminders to Secretary, NHS, R&C and copy to Principal Secretary to Prime Minister of Pakistan, Honorable Minister of NHS, R&C, CEO, DRAP, Secretary, Drug Pricing Committee, NHS, R&C in this regard.
Mr. M. Haroon Qassim requested to prioritize the burning issue of this CEC to deal with and after deliberations the house agreed to prioritize to following issues:
1. Registration / Pricing Issues
- Export Issues
3. Licensing Issues
Ms. Mahvash Tariq Siddiqi said that why not we try to park pharma industry in any other ministry as ministry of NHS, R&C is not interested in our issues. Dr. Shaiekh Kaiser Waheed replied that we are working on that and met with different ministries in this regard but unfortunately no ministry is ready to take pharma industry but we still working on it.
Mr. Ansar Farooq informed that in a meeting Minister of Commerce asked the reason of declining of exports. I replied that how our exports will grow while sitting minister of NHS, R&C told to media that our medicines are substandard. He further said that PPMA should send strong persons in DRB, Pricing and licensing meetings those capable to save and defend interests of the industry.
Any Other Item With The Permission of Chair:
A. Applications for New Enrollment:
The house agreed and approved the enrollment of the following companies as member of PPMA:
1. Vikor Healthcare, Hub, Balochistan (South Zone)
2. Festel Laboratories, Lahore (North Zone)
3. 3N Lifemed Pharmaceutical, Lahore (North Zone)
4. Bajwa Pharmaceuticals (Pvt) Ltd., Gujranwala, (North Zone)
5. Al Fazal Pharma, Lahore, (North Zone)
6. Quaper (Pvt) Ltd., Sargodha (North Zone)
7. Benson Pharmaceuticals, Islamabad (North Zone)
The issue of creating another office bearer post of “Vice Chairman” was discussed. After some deliberations, the house/CEC is decided to create post of “Vice Chairman” but subject to the approval of DGTO in the Memorandum and Article of the Association.
Mr. Ijaz A. Siddiqi informed that Punjab is going to purchase equipment for hospital worth Rs.6 million and seeking 50% donation from PPMA as Mr. Shahzeb Akram was in P.R. with the Government of Punjab, therefore he requested to put this issue in front of the house. Dr. Shaiekh Kaiser Waheed also iformed that similar appeal is received from MEDIBANK for donation and said that he will meet them and ask what exactly they want from PPMA.
As no further agenda was remained, the meeting ended with thanks to the Chair.
Assistant Secretary PPMA