ISLAMABAD: The Ministry of National Health Services and Coordination (MNHS&C) is to seek approval of the Council of Common Interests (CCI) for the formulation and implementation of National Blood Transfusion Policy with consent of Punjab government, well-informed sources told Business Recorder.
The issue came under discussion at the 10th meeting of the SIFC implementation committee on provincial matters pertaining to sectors.
According to sources, Secretary MNHSR&C updated that the ministry is in constant coordination with Specialized Healthcare & Medical Education Department (SH&ME), Punjab, adding that comments of the department were addressed twice. The CCI approval will be processed after Punjab’s stance.
Secretary Specialized Health Punjab conveyed reservations on the draft policy regarding role of the DRAP and compensation issue.
The meeting decided that blood transfusion and plasma is to remain a provincial subject, however plasma establishment and its medicinal part is to be licenced by DRAP.
It was also decided that health ministry will hold Working Group (WG)meeting including Go Punjab and all concerned stakeholders to effectively segregate the mandates of federal and provincial drug regulatory authorities.
The decision on remuneration/compensation for blood transfusion may be deliberated in CCI by the elected representatives.
Secretary MNHSR&C further apprised the meeting on the amendment in Drugs Law, proposed by the Pakistan Pharmaceutical Manufacturers Association (PPMA) and deliberated in the 57th policy Board meeting held on October 17, 2024. However, the PPMA, the originator of the amendment, requested to halt the process and requested for further discussion/deliberation with DRAP.
The meeting decided that amendment should be in accordance with international best practices. The model of successful peer countries be studied, where pharma industry has developed and is exporting. Criminal intent and liability needs to be clearly established.
MNHS&R/DRAP tasked to process the amendment after consultation with stakeholders for approval of CCI in its forthcoming meeting. Go Punjab to expedite decision on the matter from the provincial Cabinet whereas MNHSR&C to hold a Working Group meeting with all the stakeholders, including the PPMA and provinces, to deliberate on the proposals for drafting proposed amendments and forward the case to CCI/Cabinet.
Sharing update on upgradation of Drug Testing Laboratories (DTLs) of province, Secretary MNHSR&C apprised that DRAP has performed gap assessment of DTL Balochistan, KPK, Sindh and GB from November 24 to January 25. Go Punjab shared timeline of February 21, 2025 for the upgradation of laboratory.
The forum decided that MNHSR&C is to hold a WG meeting with all stakeholders, including DRAP, Go Sindh, Go Balochistan and Go KP to devise definite roadmaps with timelines for upgradation of labs and ensure that all provinces including GB & AJK to get WHO PQ by June 30, 2025.
On harmonizing rules and registration under DRAP and Drug Act among Federation and provinces, Secretary MNHSR&C apprised that Model Therapeutic Goods Sale Rules have been prepared and shared with provinces. Moreover, consultations have been done with all stakeholders, and consensus on most of the issues has been achieved. However, Go Punjab and Go Sindh are yet to develop consensus for which a final round of consultation is to be held within February.
The meeting decided that MNHSR&C to hold WG meeting with all stakeholders, including provinces, to devise a roadmap (with timelines) by end of February 2025, and ensure harmonization of rules by March 30, 2025. Health ministry will ensure submission of PICs membership by June30, 2026.
Briefing the meeting on Baby Milk Regulation - baby milk and related products are food not medicine, Secretary MNHSR&C apprised that DRAP forwarded proposed amendments in DRAP Act,2072 and Rules made thereunder, including Alternative Medicines and Health Products [Enlistment) Rules, 2014 for vetting by the Ministry of Law & Justice alter detailed deliberation with all stakeholders.
Ministry of Law & Justice’s opinion on this matter is as follows: “In view of the constitutional dispensation, as of today, the DRAP Act, 2012 was made under Article 144 of the Constitution. So if the bill is moved without resolution it will be applicable to the extent of ICT only, So the referring Division shall reconsider the case.”
The meeting decided that Working Group meeting to be arranged jointly under Secretary MNHSR&C and Secretary Law to suggest/propose way forward for early completion of the agenda and options of routing the agenda approval through CCI.
Sharing update on preventive measures against genetic disorders and Thalassemia, Secretary M/o NHSR&C, the meeting agreed that the scope of the policy to also include genetic disorder and genetic health with change of policy name to “Genetic Disorder and Genetic Health” instead of “Prevention of Thalassemia” to cover the wider issue of genetic diseases.
MNHSR&C to hold WG meeting is to finalize draft legislation of preventive measures (including genetic disorders) while taking provinces on board. MNHSR&C/provinces will process the final draft by 4th week of February 2025.
Ministry of Commerce apprised that three meetings with relevant stakeholders have been conducted. Pakistan Pharmaceutical Manufacturers Association is developing a proposal for the proposed Pharma Council and requested for another session. One-month time is required to finalise the proposal and way forward. The DRAP is of considered opinion that boosting exports of pharmaceuticals requires openness of manufacturers to the international auditors.
On increase in pharma export retention from 15 to 35 percent, the Commerce Ministry apprised that the matter is about increasing export proceeds retention rate abroad for the pharma sector. The PPMA has been directed to submit the proposal along with justification/rationale.
Copyright Business Recorder, 2025
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