India-based drugmakers must enhance manufacturing standards to address quality concerns impacting pharmaceutical exports. Amid rising scrutiny, the government is incentivizing upgrades to improve compliance and maintain global dominance in generics.
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.
The Indian pharmaceutical industry has long been a global leader in generic drug manufacturing. However, recent concerns over quality standards have prompted the Indian government to prioritize raising pharmaceutical quality benchmarks. By implementing stricter regulations and ensuring adherence to international standards, India aims to enhance the reputation of its pharmaceutical sector on the global stage.
Improving quality standards not only addresses safety concerns but also increases the competitiveness of Indian pharmaceutical companies. As countries tighten regulations around drug imports, India stands to benefit significantly from consistent high-quality products. This change will likely lead to increased investments from international pharmaceutical companies and greater access to global markets, strengthening India’s position as a vital player in the global pharmaceutical supply chain.
Moreover, enhanced quality standards will contribute to public health both domestically and internationally. By fostering trust in India’s pharmaceutical products, the government can help improve accessibility to essential medicines worldwide, ultimately supporting the country’s soft power and reinforcing its status as a responsible global health partner.
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