Vikas Biyani
India’s pharmaceutical industry, widely recognised as the ‘Pharmacy of the World,’ faces a significant threat as substandard Isopropyl Alcohol (IPA) and non-pharmacopoeia grade IPA from China floods the market. This alarming trend not only endangers public health but also undermines India’s self-reliance journey and its global standing as a quality manufacturer of pharmaceutical products.
This critical solvent, especially in its pharmacopoeia-grade form, is essential for manufacturing safe and effective drugs and medical supplies. However, the growing influx of substandard and non-pharmacopoeia grade IPA, primarily from China, poses grave risks. By FY 2023, Chinese imports accounted for 64 per cent of India’s IPA supply, up from 57 per cent in FY 2020. The use of this substandard material compromises the quality and safety of pharmaceutical products, threatening public health on a large scale.
India’s reputation as a global provider of affordable, high-quality medicines is at stake. The use of non-pharmacopoeia grade IPA can severely compromise the efficacy and safety of life-saving drugs. With 75 per cent of IPA consumption in India directed towards the pharmaceutical industry, ensuring the use of only quality IPA including pharmacopoeia grade IPA as per pharmaceutical industry requirement is crucial and a matter of public safety.
The unchecked dumping of underpriced, substandard IPA from China is also a direct threat to India’s efforts toward Atmanirbhar Bharat (self-reliant India). As local producers struggle to compete with the flood of low-cost imports, India’s ability to maintain its current production capacities is at risk. Expanding new domestic capacities may become financially unviable under current market conditions, potentially disrupting the country’s strategic objective of self-reliance on essential pharmaceutical supplies.
India’s journey towards Atmanirbharta in the pharmaceutical sector is severely affected if the influx of substandard IPA and non-pharmacopoeia grade IPA continues unchecked. This will not only make public health suffer, but the long-term viability of India’s domestic pharmaceutical production could collapse, much like what happened with Penicillin-G in the early 2010s. That collapse led to a dependency on imports and exposed the sector to sharp price hikes and supply disruptions.
In response to this critical issue, the Directorate General of Trade Remedies (DGTR) has made recommendations for the imposition of anti-dumping duties on Chinese IPA imports. Once implemented by the government, this positive step will provide crucial support to the domestic industry, helping stabilise prices, safeguard local jobs, and ensure the continued production of high-quality, safe pharmaceutical products.
The DGTR’s recommendation for anti-dumping measures is a critical intervention. It will help to achieve Atmanirbharta in the pharmaceutical sector by ensuring the availability of quality inputs from domestic industry, reinforcing public health safety, and upholding our country’s position as a global leader in pharmaceuticals. Swift implementation by the government is essential to prevent long-term damage to the sector and to ensure that India continues to provide high-quality, affordable medicines to the world.”
As India strives to retain its leadership in global pharmaceutical exports, valued at INR 2.32 trillion in FY 2022-23, protecting the quality of all input materials including solvents is paramount. By supporting domestic industries and regulating substandard imports, India can ensure that its pharmaceutical sector remains resilient, globally competitive, and aligned with its Atmanirbhar Bharat vision.
Vikas Biyani is a seasoned FDA Regulatory Consultant with extensive
experience in the Food and Drug Administration, Maharashtra
