WHO, UNAIDS Urge Pakistan to Locally Produce HIV and TB Drugs After Indian Supply Disruption
10 June 2025
Alarmed by Pakistan’s dependence on Indian-manufactured medicines for HIV/AIDS and tuberculosis (TB) treatment, global health agencies have called on Pakistani pharmaceutical firms to urgently initiate local production of these life-saving drugs.
The World Health Organisation (WHO) and UNAIDS believe that the country’s heavy reliance on imported antiretroviral therapies (ARVs) and TB medicines poses a significant public health risk, particularly in the light of strained trade relations with India.
In a high-level meeting involving the Drug Regulatory Authority of Pakistan (Drap), the Ministry of National Health Services, WHO, UNAIDS and other stakeholders, officials warned that most medicines for HIV/AIDS and TB currently being distributed under the UN and Global Fund-supported programmes in Pakistan are manufactured in India. With trade ties suspended, the continuity of care for thousands of patients now faces uncertainty.
According to health officials, an estimated 350,000 people in Pakistan are living with HIV, but only around 76,167 are registered with the National AIDS Control Programme, and 53,635 are receiving ARVs. Meanwhile, Pakistan reports over 500,000 to 600,000 new TB cases annually, making it one of the top five high-burden countries in the world. These figures highlight an urgent need for consistent and localised medicine supplies.
However, for Pakistani pharmaceutical products to be eligible for international procurement through WHO, Global Fund or UNAIDS programmes, they must be WHO-prequalified — a process that ensures safety, quality and efficacy based on international standards.
Officials at the meeting revealed that only four Pakistani pharmaceutical products currently held WHO prequalification status: Remington’s Levofloxacin 250mg tablets, PharmEvo’s dispersible zinc tablet and oral zinc solution, and Schazoo Zaka’s TB products manufacturing facility. The Getz Pharma has received WHO recognition for its Moxifloxacin (hydrochloride) 400mg film-coated tablet.
It was disclosed during the meeting that local pharmaceutical manufacturers have shown limited interest in pursuing WHO prequalification due to its demanding standards, such as strict compliance with Good Manufacturing Practices (GMP), readiness for global inspections and investment in process upgrades.
Drap officials acknowledged these challenges but emphasised the long-term value of achieving international recognition for local products. The special secretary of health stressed the fragility of Pakistan’s medicine supply chain and urged rapid movement toward self-reliance. He called for a mapping exercise to identify pharmaceutical manufacturers already exporting to countries with a Stringent Regulatory Authority (SRA), making them eligible for WHO’s abridged prequalification assessment. The aim is to accelerate the qualification process for drugs critical to Pakistan’s HIV/AIDS, TB and malaria programmes.
A representative from WHO explained the prequalification process and pledged technical support to elevate Pakistan’s regulatory system to the WHO Global Benchmarking Tool (GBT) Maturity Level 3—a level required for international trust in drug regulation.
UNAIDS Country Director for Pakistan and Afghanistan Trouble Chikoko lauded the health ministry’s leadership and underscored the urgency of local production. “We’ve requested all provincial governments to include ARVs and buprenorphine in their essential medicines lists. This will enable direct procurement by provinces, ensuring sustainability and continued access for patients,” he said.
Participants at the meeting, including representatives of WHO, Drap, CMU and leading Pakistani pharmaceutical companies, agreed that the government must take ownership of this transition by incentivising local manufacturers and offering strategic support.
It was decided that Drap will issue a call for expressions of interest (EOI) from local pharmaceutical manufacturers for WHO prequalification of HIV, TB and malaria drugs. The WHO will assist in developing the criteria for EOI and help explain the process to local firms. A consultative session with manufacturers and associations will also be held in coordination with the WHO, UNAIDS, and CMU.
According to a CMU supply chain update shared in the meeting, of the 680 WHO prequalified finished pharmaceutical products (FPPs), 147 are used for HIV/AIDS, TB, and malaria — and 124 of them are of Indian origin. Locally produced DRAP-registered but non-WHO prequalified drugs currently fulfil only 30 per cent of Pakistan’s treatment needs under these programmes.
Experts stressed the critical importance of raising awareness among domestic manufacturers about market potential, facilitating local production of priority drugs, and encouraging them to invest in WHO prequalification to ensure uninterrupted access to high-quality medicines for vulnerable populations in Pakistan.
The meeting was told that the UNAIDS country director had approached the provincial governments to allocate domestic resources for procurement of ARVs and medicines for opioid agonist maintenance treatment, and to include them in the provincial standard or essential medicines lists.
By M. Waqar Bhatti
Source: The News International
