MINUTES 2ND CEC MEETING 2023-24
Marriott Hotel Karachi
December 11, 2023
Chaired by Chairman PPMA Mr. Mian Khalid Misbah Ur Rehman.
After the recitation of Holy Quran by Secretary General Nawaz Ahmed, Dua e Maghfirat was offered for few PPMA members/relatives.
Formal meeting started with opening remarks & welcome by Chairman PPMA.
AGENDA NO.1. Confirmation of the Minutes OF 1st CEC Meeting for the Session 2022-23 held at Islamabad Serena Hotel dated October 17, 2023,
Proposed by Mr. Ehtisham Ul Haq member CEC
Seconded by Mr. Syed Farooq Bukhari Ex-Officio Member CEC
AGENDA NO.2. BRIEFING ON MEETING WITH DR. JAHANZEB KHAN DEPUTY CHAIRMAN PLANNING COMMISSION/SAPM ON DRUGS ACT 1976 & DRAP ACT 2012, BY CHAIRMAN PPMA.
Chairman PPMA Mr. Mian Khalid Misbah Ur Rehman briefed the house that on request of PPMA, a meeting was held under the chairmanship of Deputy Chairman of Planning Commission (DCPC)/SAPM to address critical issues concerning the Pharmaceutical Industry. PPMA emphasized the need to resolve issues to capture the huge export potential of the pharmaceutical sector as well as enabling easy access to medicines within the country for the welfare of patients. For boosting exports, PPMA discussed the need for an environment conducive to encouraging investment in this sector. Immediate reforms were deemed necessary, emphasizing the importance of high-quality drugs. The absence of a mechanism to attract investment in the pharmaceutical sector was noted and regulatory challenges and anomalies in drug laws were presented by team PPMA in detail followed by an open discussion. Pharma Bureau supported PPMA stance and Dr. Hamid Ateeq Sarwar (REMIT) highlighted that comprehensive public-private dialogues were held with the Pharmaceutical Industry and Chambers of Commerce & Industry (Federation and Lahore) members in the past 12 months and everyone had a consensus on the way forward as was submitted to office of Prime Minister by PPMA, Board of Investment and REMIT.
SAPM Dr. Jahanzeb Khan was of the opinion that a fair pricing mechanism was essential and international best practices and rules should be adopted to address the regulatory concerns of Drugs Act and DRAP Act.
After a detailed discussion, the following decisions were taken:
PPMA to identify and compile a list of outstanding issues and share it with the Prime Minister’s Office (PMO) for immediate implementation.
PPMA, Pharma Bureau and REMIT to share a comprehensive work plan, illustrating a coherent overview of all clauses of the relevant laws and policies that must be updated in line with international references with the aim to improve access to quality and affordable medicines domestically, enhance investment and exports in the sector and generate employment and tax revenue.
House appreciated Chairman PPMA and office bearers for the hard work done done in this context.
Concluding the 1 agenda point Chairman PPMA said that, it’s imperative that we should focus in the same line & spirit at all government departments and media with a focused & specific industry objective.
Former Chairman PPMA Dr. Shaiekh Kaiser Waheed added that it is extremely important if Federal Secretary NHS stand by Pharmaceutical Industry of Pakistan to solve issues. Chairman PPMA endorsed comments of Dr. Shaiekh Kaiser Waheed and said that political coverage from PPMA end is also important so that incoming elected Govt. should also adopt/continue the policies of outgoing Govt. setup.
AGENDA NO.3. BRIEFING ON MEETING WITH PUNJAB HEALTH MINISTERS & DRUG CONTROL WING ON PUNJAB DRUG RULES 2007 PQCB (PUNJAB) & GMP INSPECTIONS BY PUNJAB GOVT.
Chairman PPMA briefed on the joint meeting with Provincial Health Ministers of Punjab & other Govt. high ups. He mentioned that GMP inspections by Govt. of Punjab are planned to continue for the improvement in manufacturing process of the industry as per DRAP and that same exercise may be adopted in other provinces as well. PPMA has drafted letter through Lawyer and submitted to DRAP against this action of Govt. of Punjab. Proposal of seminar bringing knowledge to train & develop Industrial staff is also requested to DRAP and Govt. of Punjab through that letter. Chairman PPMA said that it has been revealed that lot of GMP certifications are pending at Punjab and PPMA will talk to CEO on this issue.
Mr. Hamid Raza Former Chairman PPMA added two important points.
a) Amendment in Rules of Law of the Drug Act of Punjab which is different from other provinces. He said Chairman PQCB is also agreed on this point and has also suggested few changes in rules for the convenience of DRAP & Manufacturers with references to sub-standards and misbranded drugs and that same should be atken action as per international best practices.
b) DRAP should share Inspection Performa with the members. Same may be addressed in writing with DRAP.
It was also shared with the house that PPMA is organizing Jang Forum Pharma Seminar where this particular issue will also be taken up. In PPMa meetings, Drug Control Wing of Punjab has committed to openly state in the Forum / Seminar (which CEO DRAP will also attend) that these inspections will onlybe advisory in nature
AGENDA NO.4: BRIEFING ON MEETING WITH DG PCSIR ON RESEARCH ON APIS & COMMERCIALIZATION BY CHAIRMAN PPMA
Point could not be discussed due to paucity of time.
AGENDA NO.5: BRIEFING ON MEETING WITH CEO DRAP ON CONTROLLED DRUGS SOP REVISION, INCIDENT REPORTED BY WORLD HEALTH ORGANIZATION (WHO) ON COUGH SYRUPS
Chairman PPMA and PPMA delegates held a meeting with CEO DRAP at Lahore where this issue was discussed in depth. New proposed amendments to SOP were discussed by PPMA. Next week meeting with ANF and MoNC has been planned to finalize SOP in this connection. Proposal regarding ALR / Quota enhancement already been given to DRAP as well as to controlled drug division. PPMA suggested to consider 4 years average for issuing Quota for control drugs instead of 3-year average. Performa regarding proposed changes in SOPs control drugs shall be shared with CEC for consensus before submission to Control drugs division – DRAP, same will help us to demand legitimate quota for next year.
Issue of cough syrup raised by WHO was presented by DRAP. Case was related to one of PPMA member company’s who had exported the products CEO DRAP cautioned PPMA to create awareness of testing and identification of impurities in Glycol, Sorbitol etc as per advisory released by DRAP, PPMA advised that DRAP should re-circulate the advisory to make industry aware of the importance of the issue.
AGEDA NO.6. BRIEFING ON 331ST/332ND DRB MEETINGS BY MR. JALAL UD DIN ZAFFAR.
Mr. Jalal Ud Din Zaffar gave briefing about both DRB meetings & notes were circulated among members.
AGENDA NO.7: BRIEFING ON 293RD MEETING OF CENTRAL LICENSING BOARD BY DR. TAHIR AZAM
Dr. Tahir Azam gave briefing about 293 CLB meeting & notes were circulated among members.
AGENDA NO.8: DISCUSSION ON SOPS FOR THE MANAGEMENT OF OFFICIAL & CEC WHATSAPP GROUPS & SOCIAL MEDIA PLATFORMS, BY CHAIRMAN & SR. VICE CHAIRMAN PPMA.
PPMA Website/WhatsApp/ Social Media (Instagram, twitter) were discussed in detail. It was proposed by Chairman and Senior-Vice Chairman PPMA that access control should be in the Jurisdiction of PPMA Central Office Islamabad (General Secretary, Chairman) and that social media firm must be hired (as previously discussed in various CEC meetings) to raise awareness about the critical pharmaceutical sector and its issues among the masses. House endorsed the proposal also
agreed that only one nominee of each member company should be part of Official WhatsApp PPMA Group plus all former Chairmen and this SOP should continue strictly.
AGENDA NO.9: OATH OF MR. OSMAN KHALID WAHEED AS CEC MEMBER PPMA
Oath of Mr. Osman Khalid Waheed was administered by Chairman PPMA as nominee of Ferozesons Laboratories replacing previous nominee who had retired from the company. House recorded well wishes for him & PPMA.
NEW ENROLMENT
Company Name: Skywin Pharmaceuticals, Lahore (North)
House unanimously approved new enrollment.
ANY OTHER AGENDA ITEM WITH THE PERMISSION OF CHAIR
PPMA Central Office, Islamabad new location (if needed due to electricity tariff issues): House suggested survey 2-3 places to be finalized by Office Bearers, preferably near DRAP, if needed.
Chairman PPMA proposed short documentary film highlighting PPMA objectives and brief introduction through Professional IT specialist. That video will help give presentations before Govt. high ups specially at Federal Secretaries / Ministers level those having little or no knowledge about Pharma sector. Video will highlight Industry contribution towards tax contribution/services for human health/production/quality functions etc. House endorsed the proposal.
Taxation Committee convener should accompany the delegate PPMA while visiting FBR. In this connection relevant professional consultant may be hired from Tax department for the industry. Chairman PPMA was authorized to do so who shall give detailed presentation about taxation proposals during 3rd CEC Meeting in Lahore.
Letters received from MoC (Agro Division) were discussed for CEC consensus regarding APIs duty protection. House decided to reply with facts & figures and that unless an item is registered by DRAP, why does MoC start discussion about tariffs?
DRAP visiting timings for Regulatory Managers discussed to obtain CEC consensus. House decided to discuss the time convenience with CEO DRAP in person during next visit to DRAP.
Letter to DRAP regarding online system upgrade to be sent by PPMA
Letter to Chief Drug Inspector KPK regarding Bar Code issue to be sent by PPMA as DRAP had given time to implement serialization and KPK Drug Inspectors were not following DRAP guidelines.
CRUX OF THE 2ND CEC Meeting 2023-2024
PPMA to identify and compile a list of outstanding issues and share it with the Prime Minister’s Office (PMO) for immediate implementation.
PPMA, Pharma Bureau and REMIT to share a comprehensive work plan, illustrating a coherent overview of all clouses of the relevant laws and policies that must be addressed with international references.
PPMA Website/WhatsApp/Social Media control should be in the jurisdiction of PPMA Central Office Islamabad. Hire social media management firm.
PPMA central Office new location to be survey by PPMA Central Office team, ideally, 2-3 places to be finalized by Office Bearers, preferably near DRAP
Short documentary film highlighting PPMA objectives and brief introduction through Professional IT specialist
shall be developed through Professionals. Taxation Committee convener should company the delegate PPMA while visiting FBR. In this connection relevant professional consultant may be hire from Tax department for the industry.
House decided to give detail presentation on taxation proposals during 3rd CEC Meeting.
Skywin Pharmaceuticals, Lahore (North) has been enrolled as new PPMA member company.
NAWAZ AHMED Secretary General PPMA