Participants Govt.
- Dr. Mukhtar Ahmad Malik, Coordinator to PM on Health.
- Mr. Asim Rauf, CEO DRAP.
PPMA
- Chairman PPMA Mr. Tauqeer Ul Haq.
- Sr. vice Chairman PPMA Mr. Shafiq Ahmad Abbasi.
- Vice Chairman PPMA Mr. Aman Ullah Sheikh.
- Former Chairman PPMA, Mr. Mian Asad Shuja Ur Rehman
Following were the key achievements of the meeting:
- DRUG ACT AMENDMENTS
Chairman PPMA requested Dr. Mukhtar Bharath to share the update of drug act amendment. The Coordinator to PM apprised that they have discussed in length at different forums and revealed that, by taking the case to provincial level, deregulation matter of NEML may become under risk which they don’t want to put on stake at any cost due to positive inputs of deregulations of NEML in term of smooth availability of medicines as well as export enhancement. It is important to note that taking consensus of all provinces is imperative, commented by CEO DRAP. Chairman PPMA said that, if provinces agree on Industry point of view, then there will be no intimidations to deregulation case.
Coordinator added that, we will discuss with Law division / Policy Board and ultimately will take it to cabinet for final approval. Following points shall be taken up:
- Fine variations 20% instead 10%.
- Warrantee theme has been removed.
- Fines proportion shall be on higher side against the PPMA plea which were proposed on lower side.
Chairman PPMA said that both PPMA & Pharma Bureau raised up three asking:
- Criminal threats like unregistered, unlicensed, spurious drugs should be treated harshly.
- Warning may be issued for misbranded cases to Registered / Licensed manufacturers.
- Out of spec within 20% from label, fine may be imposed up to 1-2 million by PQCB. Incase of above 40% out of spec, assay only then the case may be refers to the drug court.
RESTRICTION OF ENTRY OF PPMA REGULATORY MANAGERS IN DRAP.
The PPMA team objected strongly & re-emphasized that DRAP being a public office why not allowing our Regulatory Mangers to enter DRAP and they are not treated well there.
Dr Bharat said that this is our responsibility to give respect to industry and advised CEO DRAP to make a proper SOP to address this issue. He advised the following:
- Entry cards to be issued for Regulatory Managers for visits.
- Thrice / twice a week visits may be allowed.
- Time limits for visits.
- Online system to be checked for improvement and app should be friendly user.
- Sit with PPMA / Pharma Bureau team and design visits through appointments system.
SEGREGATED SECTION FOR MANUFACTURE OF NARCOTIC / PSYCHOTROPIC DRUGS.
Former Chairman PPMA Mr. Mian Asad Shuja Ur Rehman briefed about the philosophy of segregated section for control drugs as per international policy. He mentioned that, world over there is no such law for Pharmaceutical manufacturers except Pakistan. He urged to remove this needless condition enabling manufacturers to focus on quality manufacturing withing licensed units.
