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Business Recorder
2 days ago
- Business
- Business Recorder
SHC rejects pharma firm's pleas seeking hike in drug prices
KARACHI: The Sindh High Court dismissed two constitutional petitions filed by a leading pharmaceutical company, which requested for the increase of the Maximum Retail Prices (MRP) of certain drugs up to 10 percent instead of 7 percent annually, approved by the DRAP. The verdict, delivered by a division bench comprising Acting Chief Justice Muhammad Junaid Ghaffar and Justice Mohammad Abdur Rahman, had the core of the legal dispute originated from a pricing of three commonly used medicines including Brufen (tablet) 200mg, Brufen Suspension 120ml, and Thyronorm (Tablet) 125 mcg. Abbott sought an annual MPR increase of up to 10 percent for the fiscal year 2023-24. The company's argument hinged on the historical categorization of these medicines as 'lower priced drugs' under Rule 10 of the Drug Pricing Policy, which traditionally entitled them to a CPI-linked increase of up to 10 percent. Abbott asserted that it had submitted the required calculations to DRAP on July 1, 2024, and that the authority's failure to issue a decision within the stipulated 30 days should, under Rule 7(2)(ii) of the policy, result in their self-determined revised prices being deemed approved and officially notified. DRAP, represented by the Assistant Attorney General for the Federation of Pakistan, contested this position. The regulatory body asserted that the MRPs of these specific medicines had, over successive years of CPI-linked adjustments, gradually escalated and now surpassed the maximum thresholds prescribed for 'lower priced drugs' under Rule 10(1) of the policy. Consequently, DRAP had reclassified them as 'other drugs,' thereby capping their permissible annual increase at 7 percent instead of the 10 percent sought by Abbott. This reclassification and DRAP's subsequent decision were upheld by its Appellate Board, compelling Abbott Laboratories to seek judicial intervention through the constitutional petitions, specifically challenging DRAP's order dated March 12, 2025, and previous orders from November 7, 2024, as 'illegal, unlawful, unconstitutional, without jurisdiction, malafide, and of no legal effect.' The High Court, in its detailed judgment, rejected Abbott's argument for 'deemed notification' or 'deemed approval.' The court clarified that rules allow for the deemed issuance of revised MRPs only if the submitted calculations are 'in conformity with' and represent 'correct calculations' under the policy. Since Abbott's claim was predicated on categorizing the medicines as 'lower priced drugs' despite their MRPs having already crossed the officially notified thresholds, the court held that Abbott's calculations were not policy-compliant. Addressing Abbott's contention that the same medicines were recognized as 'lower priced drugs' in the preceding year despite exceeding the threshold, the court stated that even if such a regulatory oversight occurred previously, it could not justify repeating the error. The court underlined the legal maxim that 'two wrongs do not make a right,' rejecting the notion that a past administrative lapse could serve as a binding precedent or justification for current policy violations. The court also drew attention to a crucial procedural lapse by the Ministry of National Health Services, Regulations and Coordination. The judgment noted that under Rule 10(2) of the Drug Pricing Policy, the Ministry is legally obligated to revise the thresholds for lower-priced drugs annually in accordance with CPI changes. This statutory requirement, the court observed, had not been fulfilled, thereby indirectly contributing to pricing, however, because Abbott Laboratories had not directly challenged this specific omission in its petitions, the court refrained from issuing a definitive order on this matter due to jurisdictional limitations. Nonetheless, the court acknowledged that the issue 'warrants attention' and granted Abbott Laboratories the liberty to pursue this concern independently before the Ministry or any other competent legal forum. The court directed that any such representation filed by Abbott in this regard must be decided upon by the respondent within 60 days. The Sindh High Court found no merit in Abbott Laboratories' plea for a 10 percent price increase. It upheld the decisions of DRAP and its Appellate Board as 'legally correct,' given the undisputed fact that as of July 1, 2024, the MRPs of the disputed medicines had indeed exceeded the thresholds specified for lower-priced drugs, thereby disqualifying them from such categorization. Copyright Business Recorder, 2025
Business Recorder
13-06-2025
- Business
- Business Recorder
DRAP STRN deregistration case: FTO orders swift conclusion
ISLAMABAD: Federal Tax Ombudsman (FTO) has instructed the Large Taxpayers Office (LTO), Islamabad to promptly conclude proceedings in the matter of de-registration of Sales Tax Registration Number (STRN) application of Drug Regulatory Authority of Pakistan (DRAP). The complaint was filed under Section 10(1) of the FTO Ordinance, 2000, citing prolonged inaction by the tax authorities despite clear directions from the Appellate Tribunal Inland Revenue (ATIR) to reconsider the case afresh. The Complainant pointed out that no decision had been made on their statutory application for de-registration, while notices continued to be issued for tax compliance, resulting in procedural confusion and administrative hardship. FTO observed that the delay in implementing the Tribunal's order and inaction on the de-registration request fell within the definition of maladministration as per Section 2(3) of the FTO Ordinance. The matter is further complicated by a legislative amendment that potentially exempts regulatory and licensing bodies like DRAP from certain taxes under the Islamabad Capital Territory (Tax on Services) Ordinance, 2001. The LTO in its response claimed that remand proceedings were underway, and a hearing notice had already been issued. However, no final order had been passed. The complainant's authorized representative confirmed receipt of the notice but emphasized that the application for de-registration had still not been adjudicated. Taking serious note of the administrative delays, the FTO has directed the Chief Commissioner, LTO Islamabad to expedite the conclusion of de novo proceedings in line with the Tribunal's remand order and decide the complainant's pending application for de-registration in accordance with applicable laws. The LTO has been asked to submit a compliance report within 45 days. This direction by the FTO reflects a continued push for institutional responsibility and fair treatment of taxpayers by ensuring due process is not sacrificed at the altar of bureaucratic inertia. Copyright Business Recorder, 2025
Business Recorder
06-06-2025
- Health
- Business Recorder
Safer, smarter healthcare services: Federal, Punjab Health ministries to launch joint initiatives
ISLAMABAD: The Federal Health Ministry and the Punjab Health department have decided to join hands for stronger, safer, and smarter healthcare services. The major development for national health collaboration came here on Thursday during a high-level meeting between Federal Minister for Health Mustafa Kamal and Punjab Minister for Primary and Secondary Healthcare Khawaja Imran Nazir. The meeting focused on strengthening coordination between the federal and provincial governments to address critical healthcare challenges and launch joint initiatives across key health areas. The meeting decided taking joint action against counterfeit medicines, coordinated efforts on polio eradication and dengue prevention and advancement of digital health systems and regulatory reform. The meeting was also attended by Special Secretary Health Syed Waqarul Hassan, Additional Secretary Health, Chief Information Officer of DRAP, Director General Health, and the President of the Pakistan Medical and Dental Council (PMDC),Dr Rizwan Taj. Kamal reiterated the federal government's resolve to address healthcare issues with urgency. He stated that under the direction of the prime minister, particular focus is being placed on eliminating polio and ensuring timely implementation of health programmes. 'The fight against polio continues with full zeal, until the virus is eliminated, our children remain at risk,' he emphasised. He shared plans for a new national strategy for polio eradication and urged parents to disregard negative propaganda and ensure their children are vaccinated. 'In Palestine, even during war, mothers call for vaccinators with whistles. Pakistani mothers must also play their part in protecting their children,' he said. Kamal highlighted steps being taken by DRAP to combat counterfeit medicines, including the rollout of a modern barcode system. This will enable every medicine to carry a unique code that patients can scan to verify authenticity and price. Additionally, export certifications such as GMP, CoPP, and NOCs are now being processed online via the Pakistan Single Window, and all regulatory submissions are handled through the new 'e-App' online platform. Provincial Minister Khawaja Imran Nazir reaffirmed Punjab's full support for the federal government's health agenda. 'Punjab has greater capacity and resources, and we are ready to share these to benefit all provinces. The health of our people must come before all else,' he stated. He also praised DRAP's initiatives under the leadership of Minister Kamal, particularly, those targeting counterfeit pharmaceuticals. The two ministers agreed on the importance of coordinated measures to prevent dengue outbreaks in Islamabad and Rawalpindi and committed to united efforts in disease prevention, vaccination campaigns, and health system strengthening. They stressed that collaboration between federal and provincial levels is crucial to achieving meaningful progress in the health sector. Copyright Business Recorder, 2025
Business Recorder
30-05-2025
- Health
- Business Recorder
Spurious, sub-standard drugs: NA body grills DRAP
ISLAMABAD: The National Assembly Standing Committee on National Health Services, Regulations and Coordination (NHSRC), Thursday, grilled the Drug Regulatory Authority Pakistan (DRAP) for ineffective monitoring and failure to control the spread of spurious, unregistered and sub-standard drugs across the country. The committee meeting was held under the chairmanship of Dr Mahesh Kumar Malani, MNA to discuss various pressing issues related to health, licensing of drugs, homeopathic and alternative drugs as well as three amendment bills. The committee disposed-off 'The Pakistan Medical and Dental Council (Amendment) Bill, 2024', moved by Shaista Pervaiz, MNA. Whereas, the debate on 'The Islamabad Healthcare Regulation (Amendment) Bill, 2024', moved by Shaista Pervaiz Malik and 'The Pharmacy (Amendment) Bill, 2024', moved by Abdul Qadir Patel, MNA were deferred due to absence of movers. Discussing the matters pertaining to the working and performance of the DRAP, the committee highlighted the acute shortage of resources, pending recruitments and the need for a robust regulatory framework to address pharmaceutical malpractice. It was recommended that rules for filling vacant positions in DRAP be expedited, alongside efforts to strengthen inspection mechanisms for pharmaceutical products and vaccines. Members also stressed the importance of harmonising drug licensing procedures to reduce delays and ensure the availability of quality-assured medicines. The committee urged DRAP to adopt a more proactive approach in monitoring drug efficacy, availability and pricing to safeguard public health interests. The committee members also recommended enhancing the existing penalties for non-compliance of standards. Additionally, the need to prioritize local manufacturing of essential vaccines was emphasised to minimise reliance on imports and ensure a steady supply. The committee commended DRAP for its efforts to digitize the drug licensing application process. It was noted that a standardised harmonised form has been developed to streamline licensing procedures. The committee emphasised the importance of establishing clear and stringent rules for drug licensing to enhance transparency and efficiency. Additionally, the committee directed DRAP to share the finalised licensing rules in the next meeting. Briefing the panel, Dr Obaidullah, chief executive officer (CEO) DRAP said that the organisation was facing serious shortage of staff not only at senior level but junior level, adding that monitoring and controlling of spurious, substandard and unregistered drugs was not only DRAP's responsibility but largely provincial governments' were responsible for it as health after 18th constitutional amendment was a devolved subject. He said that the DRAP was making all possible efforts to ensure effective regulation across the board and to deal with the staff shortage board has sent a summary to the federal government. The committee discussed several issues such as the regulation of food standards, healthcare governance and recruitment practices. The committee members expressed concerns over the Ministry of Science and Technology's delay in addressing unresolved matters related to food product standards, particularly the introduction of front-of-package warnings. Recognising the adverse health impacts of ultra-processed foods, the committee recommended imposing a levy on such products. The revenue generated would support health promotion initiatives aimed at combating non-communicable diseases. The issue of administrative inefficiencies and recruitment delays at institutions such as Polyclinic and the Islamabad Healthcare Regulatory Authority (IHRA) was also discussed in depth. Members urged immediate action to ensure transparency and fairness in hiring practices. The committee directed the ministry to submit detailed reports on recruitment processes and measures to enhance institutional accountability in the next meeting. The meeting was attended by MNAs, Dr Shazia Sobia Aslam Soomro, Sabheen Ghoury, Farah Naz Akbar, Dr Nikhat Shakeel Khan, Aliya Kamran, Zahra Wadood Fatemi, Shahram Khan, Dr Amjad Ali Khan, Shabbir Ali Qureshi, Azimud Din Zahid Lakhwi in person, whereas, Nisar Ahmed, MNA attended virtually. The minister for NHSR&C, the secretary along with senior officers from the ministry and its attached departments attended the meeting. Copyright Business Recorder, 2025
Business Recorder
09-05-2025
- Health
- Business Recorder
Ministry reviews preparedness to deal with any health emergencies
ISLAMABAD: In the wake of Pakistan-India military tensions, the Ministry of National Health Services and Coordination held an emergency meeting to comprehensively review preparedness and formulate strategies to deal with any potential health emergencies. The meeting was held here on Thursday at the National Institute of Health (NIH) under the chairmanship of Federal Minister for Health Mustafa Kamal. During the meeting, Kamal urged the provincial governments to allocate additional hospital beds and ensure adequate stock of blood and essential medicines in anticipation of any crisis. The minister emphasised that federal hospitals must continue daily operations smoothly and remain fully functional in emergency situation without any disruption. Senior officials including the Director General Health, CEO DRAP, heads of federal hospitals, representatives of the Islamabad Healthcare Regulatory Authority, Director General Health from Sindh and Khyber Pakhtunkhwa, and the Director Health from Azad Jammu and Kashmir (AJK) participated in the meeting, along with other key stakeholders. Addressing the participants, Kamal stated, 'India is an unreliable adversary. We must remain fully prepared for all possible scenarios. The Ministry of Health and its subordinate institutions will stay on high alert.' The health minister directed the CEO of DRAP to ensure uninterrupted supply of vaccines and life-saving medicines. He also stressed to ensure alternatives arrangements for medicines currently imported from India. Furthermore, he instructed the NIH to immediately enhance its capacity for local vaccine production. Special instructions were issued to Polyclinic Hospital to make specific arrangements for the treatment of burn victims in case of emergency. The minister also directed that the medical needs of the armed forces be met on a priority basis. Copyright Business Recorder, 2025
