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Industry-led manufacturing model vital for Pakistan’s vaccine self-sufficiency: Expert

Pakistan should overhaul its vaccine security strategy and adopt an industry-led manufacturing model that places the private sector at the centre of future vaccine and biologics production to end Pakistan’s donor dependency. The call comes from biotechnology specialist Farooq Mustafa, Director Quality Operations and Biotech at Macter International, who has proposed a detailed policy framework advising the government to rapidly develop domestic capability to produce all essential vaccine antigens and biological drug substances.

He warns that Pakistan’s heavy reliance on donor agencies has become a national security risk and must be replaced with a sustainable, market-driven system by 2031.

Mustafa recommends that the government allow the private sector to take full responsibility for manufacturing, technology acquisition and innovation, while the state focuses on long term financing, large scale incentives, regulatory reform and infrastructure support. His framework argues that Pakistan can end donor dependency within six years if private companies already active in biological drug formulation and fill-finish operations are prioritised and given the right policy environment to scale.

At the heart of his recommendations is the creation of domestic capacity for at least five to seven vaccine manufacturing plants, owned and operated entirely by private companies. Mustafa urges the government to provide zero-cost or subsidised industrial land, twenty year interest free loans with long grace periods, tax holidays, duty-free import of specialised machinery and raw materials, and advance purchase agreements guaranteeing domestic demand.

He says these are essential first steps if Pakistan is to produce all thirteen antigens required for the national immunisation programme and the country’s broader biological drug needs.

Farooq Mustafa pushes for a strong governance structure to steer the reform process. He proposes establishing a National Vaccine Security Council chaired by the Prime Minister and including key federal and provincial ministers, defence officials, academics, private industry leaders and the president of the Pakistan Pharmaceutical Manufacturers Association.

This body would be responsible for strategic oversight, policy decisions, approval of international technology partnerships and coordination during emergencies. Alongside it, he recommends that the Special Investment Facilitation Council take charge of fast-tracking industrial projects, removing regulatory bottlenecks, guiding technology transfers and enabling public-private partnerships.

A major section of his framework focuses on transforming the Drug Regulatory Authority of Pakistan. Mustafa calls for DRAP to achieve WHO Level 3 qualification by 2027, which would allow Pakistan’s manufacturers to seek international recognition and export opportunities.

He proposes creating a dedicated vaccine regulatory unit, fast-track approval pathways, risk-based inspection systems, regulatory advisory committees that include private sector experts, and regulatory sandboxes to support innovative biotech firms.

The financial architecture he outlines centres on a National Vaccine Industry Support Fund financed through government allocations, immediate deployment of existing health reserves, international development loans and mandatory private investment. Mustafa recommends interest-free twenty year loans, subsidised working capital, fifteen year tax holidays, full first-year equipment depreciation and subsidised utilities.

Farooq Mustafa also proposes industrial land at zero or heavily discounted rates, pre-approved environmental clearances and ready-built waste management systems in pharmaceutical parks to reduce start-up barriers for manufacturers.

A large part of Mustafa’s plan is dedicated to strengthening research and academic systems. He advises the government to allocate ten billion rupees over five years for competitive university research grants, joint industry-academic research projects, PhD and postdoctoral programmes in vaccine sciences and international collaboration.

Shared BSL-3 containment labs, analytical testing centres, seed banks and pilot-scale plants are proposed to support both academia and industry. He also recommends major tax incentives for companies funding university research and significant government co-funding for clinical trials.

Human resource development is described as a crucial pillar for independence. Mustafa suggests training five hundred professionals annually in vaccine technologies, subsidising most of the cost of international training for companies, and integrating industry internships and placements into university programmes. He also calls for faculty exchange initiatives and sabbatical opportunities in private companies to help academic institutions acquire practical expertise.

Mustafa highlights that a self-sufficient vaccine industry must also target global markets. He proposes export-oriented strategies such as support for WHO prequalification, export credit guarantees, international marketing assistance, trade promotion activities, and regulatory harmonisation with target markets including Muslim countries where halal-certified vaccines could offer Pakistan a competitive advantage. For domestic market development, he recommends transparent public procurement mechanisms, insurance coverage for vaccines and structured partnerships with private healthcare providers.

The framework outlines several risks, including market volatility, technology transfer complications, regulatory delays, political shifts and international pressure on incentive structures. Mustafa recommends long term policy continuity, diversified industry participation, insurance and guarantee schemes, risk sharing mechanisms and continuous engagement with stakeholders. He also calls for environmental compliance, renewable energy integration and local community development in new pharmaceutical zones.

International cooperation is central to the plan. Mustafa urges the government to support private sector technology transfer agreements with China, Iran, Turkey, Malaysia and the UAE. He also suggests engaging multilateral institutions such as WHO, the Islamic Development Bank, the World Bank and the Asian Development Bank for financing, training and regulatory harmonisation.

In concluding his proposal, Mustafa warns that Pakistan’s annual vaccine bill could touch one hundred billion rupees by 2031 if external dependency continues. He says the financial and strategic cost of inaction will far exceed the investment required for a private sector–led system. He recommends immediate cabinet approval of a new vaccine security policy, formation of the National Vaccine Security Council, launch of long term loan facilities, allocation of industrial land, release of university research grants and international investment roadshows.

Mustafa argues that Pakistan now faces a defining moment. It can either continue relying on donors or build a competitive domestic vaccine industry based on private sector strength, government facilitation and university-driven research. The choice, he says, will determine whether Pakistan remains dependent or becomes a global player in vaccines and biotechnology.

(Farooq Mustafa is Director Quality Operations & Biotech., Macter International Ltd. Karachi, Pakistan)

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