Generic medicine in India

These medications contain the same active ingredients, dosage form, strength, route of administration, quality, and intended use as their brand-name counterparts but are typically sold at significantly lower prices.

[1] The Indian generic medicine market has risen to international prominence due to the country's ability to produce affordable, high-quality medications, particularly following the 1970 Patent Act which permitted domestic companies to manufacture drugs using alternative processes.

[3] Key initiatives include the Pradhan Mantri Bharatiya Janaushadhi Pariyojana (PMBJP), launched in 2016, which aims to provide affordable, high-quality generics to all citizens, with a particular focus on marginalized groups.

[2][7] Despite these efforts, the promotion of generic medicines faces challenges such as public perception issues, concerns about quality assurance, and economic barriers, especially affecting access in rural areas.

[8][9] As the Indian generic pharmaceutical sector continues to expand, ongoing government support and public health campaigns are critical to addressing these challenges and enhancing healthcare outcomes.

[10] Ultimately, generic medicines play a vital role in the Indian healthcare system by offering substantial economic benefits and improving health equity across the nation.

[2][3] Furthermore, the Ayushman Bharat PM-JAY scheme, launched to provide health insurance coverage for vulnerable families, has underscored the importance of generic medicines by ensuring that beneficiaries have access to essential medications during secondary and tertiary care hospitalization.

[3] As India continues to solidify its position as a global leader in the production and export of generic medicines, sustained policy support and innovation within the sector will be crucial in addressing the healthcare needs of its population and beyond.

Launched in November 2016, the Pradhan Mantri Bharatiya Janaushadhi Pariyojana (PMBJP) is a significant initiative designed to provide affordable, high-quality generic medicines to citizens throughout India.

By offering a wide range of generic alternatives at considerably lower prices, the PMBJP has empowered communities and contributed to improved health outcomes nationwide.

[5][14] The primary objectives of the PMBJP include: The Jan Aushadhi initiative, which commenced in 2008 under the Department of Pharmaceuticals, plays a vital role in promoting generic medicines.

[4][7] The government has also implemented regulatory reforms to streamline the approval process for generic drugs, making it easier for more manufacturers to produce and distribute these affordable options.

[4] Moreover, efforts to support the domestic pharmaceutical industry include incentives for manufacturing generic drugs and promoting exports, thereby bolstering the "Make in India" campaign and creating job opportunities through initiatives like the Jan Aushadhi Pariyojana.

While the Government of India has established the Pradhan Mantri Bharatiya Janaushadhi Pariyojana (PMBJP) to ensure quality assurance through accredited laboratories,[17] gaps still exist within the broader regulatory framework.

[7] The absence of a universally implemented and systematic approach to guaranteeing the quality and safety of all generic drug production undermines efforts to promote these more affordable alternatives.

[8] Doctors often prescribe brand-name medications due to established trust and perceived efficacy, which limits the adoption of generics, despite their lower costs and equivalent effectiveness.

[8] The Indian government has made affordable healthcare a priority, implementing initiatives such as the Pradhan Mantri Bharatiya Janaushadhi Pariyojana (PMBJP) to encourage the prescription and use of generic medicines.

[19][20] Expanding the range of products available and implementing digital initiatives could also be crucial in overcoming barriers to access and ensuring sustainable growth in India's generic medicines sector.

The Indian pharmaceutical industry is well-positioned to capture a substantial share of the global market, particularly with a significant patent cliff expected by 2030, involving over 20 drugs valued at approximately $251 billion.

Initiatives like the Pradhan Mantri Bharatiya Janaushadhi Kendra (PMBJK) aim to enhance healthcare accessibility by providing affordable generic medicines, particularly for economically disadvantaged populations.

[23] The Indian pharmaceutical industry, currently the third largest globally by volume, has the potential for significant growth, with projections indicating a market size of around USD 120-130 billion over the next decade.