India’s pharmaceutical industry is projected to target a size of $ 130 billion by 2030, more than double its current size of $ 58 billion in 2024. As the “Pharmacy of the World,” India holds a unique position globally, and maintaining trust, reliability, efficacy, and safety in health care products is pivotal for sustaining this growth and enhancing its competitive advantage across the global health care ecosystem.
In January 2024, the government took a significant step by notifying Schedule M, ensuring that Indian drug manufacturing guidelines align with global standards, benefiting both patients and the industry. However, the compliance deadline for Good Manufacturing Practices (GMP) under Schedule M of the Drugs and Cosmetics Act was extended from January 1, 2025, to December 31, 2025, emphasising the need to reinforce this foundation. Industry bodies representing micro, small and medium enterprises (MSMEs) have requested an extension until December 31, 2026, citing the need for more time to complete necessary upgrades, secure funding, and provide adequate training.
India has earned its position as a global pharmaceutical leader. In 2023-24, pharmaceutical exports were valued at $ 22 billion, making them the fifth-largest export category and contributing 5% to India’s total exports. As the largest exporter of medicines among developing nations and ranking 11th globally, the Indian pharma industry has achieved remarkable milestones. However, recent incidents including substandard cough syrups linked to fatalities and contaminated eye drops highlight the critical importance of prioritising quality.
The quality of pharmaceutical products is fundamental to the pharma industry success in global markets. Ensuring quality safeguards, the safety, efficacy, and compliance of medications, thereby building trust among patients and consumers. Importing countries have established stringent mechanisms and processes to assess the quality of pharmaceuticals sourced from other nations. The United States Food and Drug Administration (US FDA), for instance, conducts rigorous inspections of manufacturing facilities in India, granting certification to those that meet its regulatory standards.
Currently, approximately 650 Indian facilities hold US FDA approval, the second largest globally, next to the US, representing nearly a quarter of all US FDA-approved facilities outside the US. Similarly, the European Medicines Agency (EMA), responsible for evaluating and supervising pharmaceutical products, has certified 380 facilities in India. However, this certification process is highly resource-intensive and costly. Thanks to ongoing collaboration between the government and industry stakeholders, Indian pharmaceutical companies have made significant progress in meeting the high standards set by the US FDA. Recent data indicates a reduction in adverse outcomes during inspections of biologics, drugs, and devices, reflecting the industry’s growing alignment with global manufacturing standards.
The Indian pharmaceutical industry is witnessing a rise in quality standards, driven by a combination of factors:
- Increased regulatory scrutiny: The Indian government has tightened regulations and inspections to ensure adherence to Good Manufacturing Practices (GMP). This has led to improved manufacturing processes and quality control measures within the industry.
- Global market demands: As India aims to expand its global market share, meeting international quality standards like those set by the US FDA and the EMA is crucial
- Focus on patient safety: Indian pharmaceutical companies are increasingly prioritising patient safety, recognising that quality is paramount for building trust and maintaining a strong reputation.
- Technological advancements: The adoption of advanced technologies like automation, data analytics, and Artificial Intelligence is enhancing quality control processes and enhancing process efficiency
Upgrading manufacturing standards is imperative for India to retain and strengthen its leadership in the global pharmaceutical industry. Compliance with international frameworks like those of the FDA, EMA, and WHO-GMP ensures the production of high-quality medicines while enhancing the credibility of Indian pharma companies.
Joining the Pharmaceutical Inspection Co-operation Scheme (PIC/S), an international association of 56 regulatory authorities, represents a strategic opportunity for India. By aligning India’s GMP standards with international benchmarks, PIC/S membership could help restore trust in Indian pharmaceuticals, especially after incidents involving contaminated syrups and counterfeit drugs.
Membership in PIC/S offers significant benefits, including access to global markets, where products from PIC/S member countries are more readily accepted, facilitating exports. Furthermore, aligning with international standards supports India’s ambition to increase the manufacturing sector’s Gross Domestic Product (GDP) contribution from 16% to 25% by 2047.
India’s pharmaceutical industry stands at a pivotal moment. By prioritising quality as a driver of competitive advantage, the sector can sustain its growth trajectory, address global challenges, and continue its legacy as a trusted provider of affordable, high-quality medicines to the world.
This article is authored by Ranjit Barshikar, CEO, QbD International, CGMP Consulting, United Nations Adviser.
