MINUTES OF PPMA DELEGATE MEETING WITH CEO DRAP

MINUTES OF PPMA DELEGATE MEETING WITH CEO DRAP
MAY 09, 2024

Participants

  • Mr. Asim Rauf, CEO DRAP.
  • Dr. Fakhar Ud Din Amir, Director PE&R.
  • Dr. Amir Latif, Deputy Director Legal Affairs.
  • Mr. Mian Khalid Misbah Ur Rehman, Chairman PPMA.
  • Mr. Ch. Israr Sharif, Sr. Vice Chairman PPMA.
  • Dr. Mahwash Khan, Vice Chairperson PPMA.
  • Mr. Mian Asad Shuja Ur Rehman, Former Chairman PPMA.
  • Mr. Aman Ullah Shiekh, Member CEC PPMA.
  • Mr. Shafiq A Abbasi, Member CEC PPMA.

Chairman PPMA initiated by congratulating CEO DRAP for new DRAP office and recorded warm wishes for DRAP & Pharma Industry.

Talking about deregulations of nonessential medicines Chairman PPMA said that, case is still with Law division and it is expected that there will be no amendment in it. We urged to federal Secretary for the earliest possible execution of the policy the moment returns from Law division once vet. Chairman PPMA said that the industry is aware of the need to exercise caution and due care in implementation of the decision. He added that it has sent the right signal to international and domestic investors looking at the Pharma sector and has already improved availability of medicines thereby substantially improving access of patients to quality drugs.

It was discussed mutually agreed that both Industry & Govt. will climax the grave nature of the Pharma Industry and try to change the fallacies at public level through positive media consciousness as well as developing faith on DRAP & Industry.

Talking about Drug Court, word “Misbranded / Criminal” should be abolished and cases should be treated under Civil law. In this connection after deliberation PPMA and Pharma Bureau will submit the proposal to Secretary NHS and Coordinator Office at the earliest.

It was strongly requested that DRAP should overcome pendencies ASAP and automation should be adopted only if it improves efficiencies and not just for the sake of adopting technology.

DRAP visiting timings were discussed and it was decided that, focal person shall be appointed by the DRAP for resolving stake holders concerns immediately.

Talking about essential category, delegate PPMA urged to rationalise the 7% cap of CPI based annual price review given the hyperinflation, devaluation, historically high markup rates and ever-increasing energy costs. Chairman PPMA added that investment in API sector shall only come when future of domestic Pharma industry is stable and that unless the cap is revised the ever-pending hardship cases always result in shortages and gives opportunities for counterfeits and smuggled products.

PPMA to furnish written proposals on these aspects both at DRAP / Federal Secretary & Coordinator Offices of NHS, R&C. Chairman PPMA said that joint proposals from PPMA and PB shall be submitted.

PIC/s standards were discussed and it was agreed that it need a thorough cost-benefit analysis especially given the strict regulation of pricing and concern of affordability of medicines by the public. Industry should be facilitated to meet the high financial pressure as this will require substantial investment. Small entrepreneurs will be the first ones to face the risk of shut down. Secretary NHS agreed that PPMA should have a detailed consultation with DRAP on a mutually agreed stepwise longer-term plan.

Lastly control drugs issue were discussed. Chairman PPMA emphasis to rationalise quota issuance enabling availability of the essential medicines freely in the market. In this connection IMC guide lines were referred to be followed.

SG-PPMA