New Delhi [India], October 3 : India's pharmaceutical industry is facing a serious threat due to the increasing import of substandard Isopropyl Alcohol (IPA) and non-pharmacopoeia grade IPA from China, according to industry experts.
IPA is commonly used as a disinfectant and cleaning agent, especially in medical devices, while non-pharmacopoeia grade IPA refers to a lower-purity version not suitable for medical or pharmaceutical purposes due to possible impurities.
Experts have raised concerns that this trend is not only putting public health at risk but also weakening India's self-reliance and global reputation as a high-quality manufacturer. The unregulated dumping of low-priced substandard IPA from China is the major reason for this.
"The unchecked dumping of underpriced, substandard IPA from China threatens India's efforts towards Atmanirbhar Bharat. Local producers struggle to compete, risking our production capacities and self-reliance on essential pharmaceutical supplies," said Vikas Biyani, an expert in FDA regulatory compliance and manufacturing of injectables.
Experts also adds that the unregulated dumping of low-priced, substandard IPA from China is undermining India's efforts towards becoming self-reliant, as envisioned by the Atmanirbhar Bharat initiative. Local producers find it difficult to compete with these cheaper imports, putting India's production capacity at risk.
By the end of FY 2023, Chinese imports made up 64 pc of India's IPA supply, up from 57 pc in FY 2020.
Vijaykumar S. Singhavi, another expert in pharmaceutical technology and regulatory affairs adds the use of substandard materials compromises the safety and effectiveness of pharmaceutical products, posing a significant threat to public health.
"Substandard solvents can lead to incomplete reactions or the formation of unwanted by-products. This means the active pharmaceutical ingredient (API) may not be produced in the correct form or quantity, reducing the drug's effectiveness. Using inferior solvents can result in lower yields during the manufacturing process. This means that less of the final product is produced from the same amount of raw materials, increasing costs and reducing efficiency,"
Under such a situation building new domestic IPA production capacities are financially unviable.
On Industry complains, the anti-dumping investigation of the Directorate General of Trade Remedies (DGTR) has recommended imposing anti-dumping duties on Chinese IPA imports.
The DGTR investigation says, "The Authority recognizes that the imposition of the anti-dumping duty would remove the unfair advantage gained by the dumping practices, prevent the decline of the domestic industry, and help maintain the availability of a wider choice to the consumers of the subject goods."
The DGTR justifies the anti-dumping investigation in this case and says "the Authority in this reference, observes that there is no prevailing specific law prohibiting the initiation of an investigation against one country, even if imports from other countries are substantial.
Therefore, the current investigation does not contravene any legal standards simply because it focuses solely on Chinese imports to assess injury."
The DGTR recommendations are pending with the finance ministry for a final call of imposing anti-dumping duty on IPA imports from China.
India's pharmaceutical exports, valued at Rs 2.32 trillion in FY 2022-23, are a major part of its global standing. By regulating substandard imports and supporting domestic industries, India can safeguard its pharmaceutical sector and remain competitive in the global market says Industry.