MINUTES 1st CEC Meeting 2023-24 October 17th, 2023

MINUTES 1st CEC Meeting 2023-24 October 17th, 2023

Serena Hotel Islamabad

Chaired by Chairman PPMA Mr. Mian Khalid Misbah Ur Rehman.

After the recitation of Holy Quran by Secretary General Nawaz Ahmed, formal meeting started with opening remarks & welcome by Chairman PPMA. In the opening remarks he mentioned about excellent work done by Ex-Officio member CEC Mr. Syed Farooq Bukhari during his tenure as Chairman PPMA & appreciated the handing over and detailed briefing to the incoming leadership. Chairman PPMA aimed to continue with good spirit with the support of CEC and senior leadership PPMA to ensure that the objectives and goals for betterment of the domestic pharmaceutical industry are achieved.

AGENDA NO.1. Confirmation of the Minutes OF 5th & 6th CEC Meetings for the Session 2022-23

Minutes of 5th CEC 2022-23 were confirmed Faisal Q Khokhar. Proposed by Mr. Syed Farooq Bukhari / Seconded by Dr.

Minutes of 6th CEC 2022-23 were confirmed Proposed by Mr. Nadeem Zaffar / Seconded by Mr. Amir Rashid.

AGENDA NO.2. APPROVAL OF CONVENER & CO-CONVENER OF PPMA SUBJECT COMMITTEES 2023-24

House unanimously approved to replace the designations of Chairman & Co-Chairman Subject Committee with “Convener & Co-Convener Subject Committees” with the term Chairman to be used only by Center Chairman and Zonal Chairman (North/South) of PPMA.

House unanimously decided to abolish Committee of Vitamin Policy because the same had been achieved and stood notified. However, in future the said committee may be activated or set-up again if needed.

Mr. Faisal Khan MD Alpha Chemicals was added along with Mr. Asad Shuja Ur Rehman as Convener for the subject committee Psychotropic PPMA.

Mr. Aman Ullah Sheikh MD Davis Pharma was added in PESA subject committee PPMA.

AGENDA NO.3. DISCUSSION ON PRICE ADJUSTMENT & PENDING HARDSHIP CASES AND MEETING WITH CARETAKER MINISTER NHS, R&C

Chairman PPMA briefed the house about meeting with Minister NHS. He said that, Meeting was very productive and the Honorable Minister asked PPMA to forward proposals for resolution of pricing difficulties, improvements in DRAP working, ensuring quality medicines remain available in the market and enhancement of exports.

Chairman PPMA extended invitation to Honorable Minister to visit Lahore so he may practically see few Pharmaceutical units working on formulation and APIs and see first- hand that the domestic manufacturing units are working at global high manufacturing standards to which the Minister agreed. Time and date shall be shared once finalized.

AGENDA NO.4: BRIEFING ON ROADMAP TO EXPORT BASED PHARMACEUTICAL INDUSTRY PROPOSED BY MINISTRY OF COMMERCE BY FORMER CHAIRMAN PPMA MR. SYED FAROOQ BUKHARI AND CHAIRMAN PPMA MR. MIAN KHALID MISBAH UR REHMΑΝ.

Chairman PPMA said that, Meeting couldn’t be set due to non-availability of Minister Commerce who was overseas. However, a letter regarding “Road Map for creating a world class, export led Pharmaceutical Industry” was served to PPMA for reply. PPMA replied them to address the subject concern with facts & figures. He requested Ex-Officio CEC member PPMA Mr. Syed Farooq Bukhari to share his experience on this subject with the house.

Mr. Syed Farooq Bukhari explained that it was a team effort in which senior leadership also played a vital role. He said that, the 1st time MoC addressed our basic long standing issues like, CRF / Directors Liability / Drug Pricing/Export/EDF etc. He urged new leadership to strongly follow up. In reference to meeting with BOI in the morning, he said both Industry & Govt, feels that, more investment will come out at the part of Pharmaceuticals sector. In this connection amendments in the laws and policies of DRAP are imperative.

Chairman PPMA added with reference to meeting at BOI with SAPM that the meeting was highly productive and SAPM asked to share specific written proposals from PPMA within one week which he shall take up at cabinet and SIFC level. Chairman PPMA said that, we will further elaborate working

done by Mr. Syed Farooq Bukhari and the final draft shall be shared with CEC for their useful consent thereafter document shall be furnished before DRAP/MONHS / BOI for their perusal.

Former Chairman Mr. Hamid Raza appreciated Chairman PPMA & Ex-Officio CEC member/Former Chairman PPMA Mr. Syed Farooq Bukhari for their efforts and urged CEC to be supportive of these activities for the benefit of the pharmaceutical industry.

AGENDA NO.5: BRIEFING ON MEETING ON CONTROLLED DRUGS QUOTA ALLOCATION & SOP BY CONVENER PSYCHOTROPIC COMMITTEE MR. MIAN ASAD SHUJA UR REHMAN

. Chairman PPMA referred to Convener Psychotropic committee Mr. Mian Asad Shuja Ur Rehman for briefing based on last meeting with MoNC.

Mr. Asad Shuja said that, we represented PPMA in that meeting in the presence of ANF & DRAP. We requested MoNC for the approval of requested / applied quota on the basis of consumption whether or not ground test be observed as the delay was not on part of DML holders. They agreed on the condition that, only applied applications shall be honored & quota of CD shall not be issued for those who haven’t applied. Mr. Asad reminded that, SOP in connection to Quota issuance of CD was discussed in depth during 5th CEC meeting of PPMA held at Karachi Marriott hotel on 29th September 2023. On the basis of CEC consent the SOP were furnished before MoNC. He said that, Secretary office MoNC also agreed to replace damaged quotas due to any unfortunate reason in the production area. He said that, after coordinating meeting with DRAP / Division of CD we will make presentation with the help of Mr. Ehtesham Ul Haq member CEC for onwards presenting to Federal Secretary MONC.

Chairman PPMA informed the house that, CEO DRAP is going to Quetta officially and upon his return we will arrange meeting with him & ANF to settled on one page for the final meeting with MoNC within month time enabling in time quota issuance for new year production.

Some CEC members suggested that Division of CD should be wound up from DRAP and only ANF/MONC should handle the whole matter of issuing Quota / ALR.

Chairman PPMA said that, by law it’s not possible due to registration process of CD with DRAP under

Drugs Act 1976/DRAP Act 2012 and legal aspects with ANF under CNS Act 1997. Mr. Ehtesham Ul Haq member CEC suggested to present case by making example case of Bangladesh and INCB as a reference of Psychotropic drugs.

House agreed to continue discussion on this important point.

AGENDA NO.6: DISCUSSION ON RISK BASED INSPECTION & MEETING & MEETING WITH CEO DRAP

Chairman PPMA refers the meeting with CEO DRAP in this connection in the light of letter written by Ex- Officio CEC Member//Former Chairman PPMA Mr. Syed Farooq Bukhari through which PPMA stance was to stop this practice till clarity of inspection objectives. He added that in case it’s mandatory then SOPs should be revised. House agreed that this matter be taken up with CEO DRAP again for clarification and positive way forward.

AGENDA NO.7: BRIEFING ON MEETING WITH BARRISTER HAROON DUGGAL ON PUNJAB DRUG RULES 2007 BY FORMER CHAIRMAN PPMA MR. HAMID RAZA & CHAIRMAN PPMA MR. KHALID MISBAH UR REHMAN.

Chairman PPMA explained that PPMA delegate met with Barrister Haroon Duggal to discuss Punjab Drug Rules 2007, especially the investigation procedure and imposition of liabilities. He said unnecessary requirements have been added in rules which can’t be fulfilled. For further deliberation on the agenda he invited views of Former Chairman Mr. Hamid Raza.

Mr. Hamid Raza said that, following points were discussed for the investigation procedure: 1. Collected sample should be inspected under current law for appropriate impartiality under the section 28 of Drug Rules.

2. For the PQCB proceedings, Rules should be amended to resolve the violation on the spot and give warnings/fines by PQCB on minor and non-critical violations.

3. In rules, recall procedure should be defined and implemented clearly.

Mr. Hamid Raza concluded that, follow up to above will surely save companies from big uncertainty and extensive and draconian litigation.

Sr. Vice Chairman Mr. Ch. Muhammad Israr Sharif stressed on the need of approved lawyers for the association through legal Affairs subject committee PPMA.

Chairman PPMA suggested that, in such case members should inform Secretary General PPMA for the consultation & legal advice from PPMA Legal Affairs Committee so that appropriate Lawyer keeping in view the city / area could be recommended.

House endorsed the suggestion.

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AGENDA NO.8: DISCUSSION ON IMAGE BUILDING INITIATIVES PROPOSED BY FORMER CHAIRMAN PPMA DR. SH. KAISER WAHEED & SR. VICE CHAIRMAN PPMA MR. CH. ISRAR SHARIF.

Upon suggestion of Office bearers House decided to engage professional to develop PPMA social media accounts through Twitter / Facebook / YouTube with access to Office Bearers & Secretary General to upload data. House also decided to form few minutes video depicting the high level technology and quality aspects of Pharma Manufacturing in Pakistan as well as the employment, tax generation and socially responsible charitable works of members. Such videos may be to be use before start of meetings with Govt. high ups and other forums like chambers of commerce, meeting

with foreign delegations etc. Sr. Vice Chairman PPMA also focus on team work. He urged members to avoid spread of negative news about industry.

Ex Officio CEC member/Former Chairman PPMA Mr. Syed Farooq Bukhari endorsed Sr. Vice Chairman wording & also urged working for image developing task. Talking about PPMA video introduction, he stressed its need due to abrupt transfers of Federal secretaries and other Govt. high ups. Video can help making them realized about progress, contribution to the economy and ethics of Pharma Industry of Pakistan.

Mr. Nadeem Zaffar member CEC commented that same will help creating better image among general public as well.

Former Chairman PPMA Mr. Hamid Raza spoke in favour of video and social media accounts and commented that new Ministers & Federal Secretaries always come from different backgrounds having no idea about the pharmaceutical industry & this video can help them to understand our point of view comfortably.

House endorsed all suggestions and asked the Office-Bearers to start working on these proposals.

AGENDA NO.9: BRIEFING ON SALES TAX REFUNDS

Chairman PPMA informed the house that, Director Regulatory PPMA maintaining good liaison with FBR concerned department for the release of Sales Tax refunds. He advisedSecretary General PPMA for the reminder email / what’s’ App messages to all PPMA members to share status of their sales tax refund applications. He asked Director Regulatory to brief the house about refunds progress.

Director Regulatory mentioned that, so far 15 companies responded to our email / what’s App messages. He said 456 million valid RPO are on the desk of Chief Refund Officer. Same will be disbursed soon, efforts are continuing.

AGENDA NO.10: BRIEFING ON 292 CLB BY MR. USMAN SHAUKAT

Mr. Usman Shaukat briefed the house about the outcomes of the 292 CLB…..

1. 9 cases of new DMLs were granted.

2. 13 cases for Additional section / Revision / Amendments were approved. 3. 20 cases of renewal / regulation of DML were approved.

4. Couple of cases regarding Quality control were decided by the board. Show cause notice cases were also heard by the board.

5. Board decided not to issue layouts without R&D sections in the future applications.

AGENDA NO.11: DR. QURAT UL AIN VICE PRESIDENT PACIFIC PHARMA TO BE CO-OPTED BY CEC DURING 1ST CEC MEETING 2023-24

House Co-opted Dr. Qurat Ul Ain as member CEC North.

NEW ENROLMENT

Company Name: Geofman Pharmaceuticals.

Chief Executive: Mr. S.M.Sadiq

Proposed by: Epoch Pharmaceuticals. Seconded by: Effroze Chemicals

House unanimously approved new enrollment.

ANY OTHER AGENDA ITEM WITH THE PERMISSION OF CHAIR

Chairman PPMA advised Secretary General PPMA to obtain written consent from Ferozsons Laboratories about retirement of their nominee in PPMA CEC Mr. Baqar Hassan and the replacement name proposed by them to continue as CEC member for the remaining term. House endorsed the decision

CEC Oath taken from Mr. Ather Nazir Sheikh by Chairman PPMA.

The meeting ended with a vote of thanks by Chairman PPMA and appreciation of Secretary General PPMA and Director Regulatory PPMA for their hard work along with the staff in North and South Zonal offcies.

NAWAZ AHMED:

Secretary Genera/Executive Director PPMA