India-based drugmakers need to upgrade manufacturing standards to protect pharmaceutical exports. The industry faces scrutiny over quality control, impacting new drug approvals. Rising cost-containment measures in key markets create opportunities.
Key View
- India-based drugmakers will need to invest in improving manufacturing standards to meet rising pressures on drug quality to protect pharmaceutical exports.
- India will continue to be a dominant force in global generic drug manufacturing and remain the primary supplier of generics in the US, but the industry continues to face scrutiny over quality control issues which will impact the approval rate of new drugs.
- Rising cost-containment measures across key developed markets, such as the US and the EU, will create new prospects for India-based generic drug manufacturers.
India-based drugmakers will need to invest in improving manufacturing standards to meet rising pressures on drug quality to protect pharmaceutical exports. On September 20 2024, India’s Department of Pharmaceuticals (DoP) announced it will double the financial incentive for drug manufacturers to upgrade their manufacturing facilities to INR20.0mn (USD0.2mn). The announcement follows a series of drug toxicity cases surrounding medicines manufactured in India, resulting in fatalities in North America, Africa and Central Asia, thereby raising serious concerns around India’s pharmaceutical exports. In 2023, the US FDA conducted more than 200 inspections in India, representing a significant increase following a lull in unannounced inspections during the Covid-19 pandemic. In January 2023, the Ministry of Health and Family Welfare issued the revised Schedule M, which outlines the Good Manufacturing Practices (GMP) and updated requirements concerning premises, plants and equipment for pharmaceutical products, aiming to elevate the quality standards of India-based drugmakers. In February 2024, the US FDA announced it will increase inspections of India’s drug manufacturing units amid growing concerns over the quality of drugs.
India’s pharmaceutical industry has been a vital contributor to the global healthcare sector, yet concerns regarding the quality and safety of medications have occasionally tarnished its reputation. The Indian government’s recent focus on raising pharmaceutical quality standards marks a significant shift towards ensuring the safety and efficacy of its medical products. Enforcing stringent regulations and boosting compliance with international standards can help elevate the industry’s credibility and effectiveness on the global stage.
Strengthening regulatory frameworks is a critical aspect of this initiative. By enhancing inspection processes, mandating rigorous quality control measures, and encouraging transparent practices, the government aims to mitigate the risks associated with low-quality production. This proactive approach not only safeguards public health but also primes Indian pharmaceutical companies for better integration into international markets, thus paving the way for expanded export opportunities.
Improving quality standards will inherently enhance India’s external positioning in the pharmaceutical domain. Globally recognized certifications and a robust track record of compliance will foster trust and reliability among overseas clients and regulatory bodies. This commitment to excellence can translate to greater market share, elevated foreign investments, and a bolstered reputation as a global pharmaceutical hub, thereby contributing significantly to the nation’s economic growth and international standing.