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India’s production of affordable generic medicines sustains a global lifeline, but it must fortify quality assurance | The Leaflet

World Health Day 2025 Opinion Leaflet Specials

India’s production of affordable generic medicines sustains a global lifeline, but it must fortify quality assurance

Strengthening quality assurance at the time of approval of medicines at the State level and endorsing a pro-public health patent system will be crucial to sustain India’s ability to supply quality, affordable medicines worldwide

Leena Menghaney

Published on: 11 April 2025, 03:54 pm

India’s production of affordable generic medicines sustains a global lifeline, but it must fortify quality assurance

INDIA’S SUCCESS IN PRODUCING AFFORDABLE GENERIC MEDICINES has been decades in the making, built on strategic policymaking since the 1970s, regardless of the political party in power. The country’s ability to develop both active pharmaceutical ingredients (APIs) and finished formulations independently—without technology transfer from multinational corporations or high-income countries—has positioned it as a vital player in global health and security. The recent exclusion of pharmaceuticals from increased import tariffs by the Trump administration, for example, highlights the critical role that affordable generic medicines play in keeping healthcare costs under control, even in high-income settings.

However, this self-reliance in production of essential medicines is not an accident. It is the result of decades of public sector investment, strong position against increasing intellectual barriers beyond the requirements of the World Trade Organisation in trade negotiations (known as ‘TRIPS plus’ provisions), and a regulatory environment that has historically prioritised competition and accessibility over monopoly control over the market and supply chain of pharmaceuticals.

The pillar of global health

India’s role in supplying affordable medicines has been crucial in combating health emergencies such as drug-resistant tuberculosis, epidemics like HIV/AIDS, and public health crises like viral hepatitis. By cutting the costs of life-saving drugs by up to 99 percent, India has expanded treatment access in high-burden, resource-poor settings. The country has been a cornerstone in terms of providing affordable treatments for HIV/AIDS, tuberculosis, viral hepatitis, and malaria to public health programs in low- and middle-income countries. Increasingly, efforts are being made to explore the potential of India supplying medicines for non-communicable diseases and rare diseases.

By cutting the costs of life-saving drugs by up to 99 percent, India has expanded treatment access in high-burden, resource-poor settings.

Any weakening of India’s position in trade negotiations will allow the US and EU to seek extended patent monopolies and introduce new IP barriers on vital pharmaceuticals on behalf of their pharmaceutical corporations. It could entangle India’s National Drug Regulatory Authority in enforcing patent rights and data exclusivity, restrict the ability of Indian courts to provide relief in cases of patent abuse or dominant market positions, and limit generic competition. This would undermine patient access in India and globally, and deepen health inequities worldwide. Already Indian courts are grappling with the impact of product patents and balancing the push for patent enforcement from pharmaceutical corporations with the patient’s constitutional right to life. A series of writ petitions and interventions filed by parents of children with rare diseases seeking newer therapies that save lives demonstrates this.

The urgent need for a quality assurance approach to medicines

Protecting generic drug manufacturing capacity in India also requires consistent quality assurance in the supply of essential medicines—especially those destined for its domestic and middle- and low-income markets. Alerts on sub-standard medicines are routine in Indian states.The WHO has alerted that substandard medicines exported to Gambia and Uzbekistan from India. Inspections by Nepal’s National Drug Regulatory Authority revealed that several Indian companies were not complying with good manufacturing practices (‘GMP’).

Notably, these substandard drugs had been licensed and GMP certified not by India’s Central Drugs Standard Control Organization (‘CDSCO’), but by various State Licensing Authorities (‘SLAs’), which means that there is a critical gap in addressing quality in the current drug regulatory system.

Currently, approval of medicines and oversight at the post licensing stage in India is fragmented between CDSCO and the SLAs under the Drugs and Cosmetics Act. While the CDSCO is responsible for the approval of new drugs, the regulation of older formulations—those approved more than four years ago—falls under the jurisdiction of the SLAs. With 28 SLAs, licensing authorities in 8 union territories and the CDSCO, there are 37 distinct authorities involved in drug licensing and regulation, resulting in a fragmented system that often leads to inconsistencies in quality assurance.

This challenge is further compounded by the confusion between quality control and quality assurance among policy makers. Quality control focuses on testing the finished pharmaceutical product for contamination and whether it has sufficient API, mostly conducted at the time of procurement and delivery. Quality assurance focuses on preventing quality of the medicine from deteriorating throughout its shelf life. Both are important to ensure that sub-standard medicines do not enter the supply chain.

With 28 SLAs, licensing authorities in 8 union territories and the CDSCO, there are 37 distinct authorities involved in drug licensing and regulation, resulting in a fragmented system that often leads to inconsistencies in quality assurance.

The lack of quality assurance at the time of approval is a significant gap. The CDSCO has made progress by integrating the quality assurance approach by requiring that manufacturers submit a ‘common technical dossier’ for approval of new drugs. This ensures comprehensive review of the medical product dossier with information on a drug’s formulation, the source of its ‘active pharmaceutical ingredient’, manufacturing process, and stability studies that take into account climatic variations such as high temperatures and humidity. It also includes in vivo or in vitro equivalence testing and biowaivers based on the Biopharmaceutical Classification System to mitigate the risk of therapeutic inequivalence, along with compliance with good manufacturing standards.

However, such reform must extend beyond the CDSCO. State-level agencies must also be included in efforts to strengthen the quality assurance framework.

Middle- and low-income countries will not stand up to protect affordable generic drug manufacturing in India when it comes under pressure from Big Pharma and the governments that back these corporations unless it ensures quality for all essential medicines already on the market—both domestically and those meant for export. This is especially critical for low-income countries, where national drug regulatory authorities often lack the resources to independently assure the quality of imported medicines from manufacturing sites in India.

A failure to address these vulnerabilities will undermine public health by contributing to drug resistance. Further, treatment providers do not want to adopt good practices such as generic prescription as they prefer to prescribe expensive brands that they think are more likely to not be substandard, thus driving up costs for patients. It also leaves India's generics industry open to criticism and attack from multinational pharmaceutical corporations that seek to discredit generic medicines to protect their own market dominance.

Defending India’s competitive edge for public Health

The pressure from Big Pharma to weaken India’s capacity to produce generic medicines are not new. Labelling Indian generics as counterfeit has been a longstanding tactic to block legitimate trade in affordable medicines. If India fails to fortify its quality assurance for medicines, such attacks will gain traction, potentially restricting access to life-saving drugs for millions worldwide. This is why it is imperative to consolidate the progress in quality assurance made in the areas of HIV, hepatitis, TB, and malaria and extend them to all essential medicines.

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