Last Updated on February 7, 2022 by The Health Master
Isopropyl Alcohol IP will uplift the prestige of the Pharma sector
The pandemic has set many new normals to follow. This has been particularly true in the business world, which has been forced to adopt and adapt to practices that can ensure continuity with fewer disruptions.
While we have significantly moved toward being a contactless world with a lot of digitization put in place to ensure health and safety while returning to normalcy, some areas still need a closer look and attention.
Health and wellbeing With having acquired a center stage, we have heard lots of discourses on do’s and don’ts to avoid the deadly virus.
But a sector that needs to pay heed and ensure course correction is the one that has been at the focal point during the past 2 years and more.
Take the example of isopropyl alcohol, commonly called IPA, which is a vital input used in the pharma sector. It has been at the forefront of the war against the deadly virus because of its widespread use in disinfectants and hand sanitizers.
The demand for it went up exponentially resulting in certain factors being neglected which could hurt negatively.
Several hand sanitizer manufacturers have mushroomed all over the place to meet the high demand for the product.
Safety of the masses has been relegated by using non-recommended, substandard & cheap solvents for making hand sanitizer and to make a quick buck out of the situation throwing it out of the window.
The pharmaceutical sector is the primary end-user of IPA in India, consuming around 70-75 percent of the overall IPA available. It consumed roughly 170,000 MT. of the overall IPA demand in FY21.
Also known as isopropanol, Isopropyl Alcohol (IPA), is used to make several industrial and household compounds. It has a lot of uses in the pharmaceutical industry, especially in the synthesis of bulk medicines and drug formulations.
The problem lies exactly in the huge demand for the product. Sadly, of the 170,000 MT of IPA consumed by the pharma industry, only about 12 percent is pharma grade, meeting Indian and other pharmacopeia standards, which means a huge part of it is non-pharma grade.
Tho the law needs pharma companies to use pharma-grade IPA in manufacturing various pharma products, the ground reality is starkly different.
The majority of IPA consumed by the Indian Pharma industry is that of the non-IP grade, which fails to meet various critical parameters covered in Pharmacopeia Standards across the world.
This failure to meet these parameters eventually leads to the usage of substandard material and ultimately compromises the quality of the drugs manufactured.
The China impediment
The market for Isopropyl Alcohol has had its share of issues in India, the Chinese effect being one of the worst.
With a large number of products that China manufactures at a reasonably low-cost advantage, surplus quantities from there are sought to be exported to countries like India which have low regard for quality and high regard for lower prices.
Europe and the United States have been fighting the Chinese onslaught of lower-priced quality compromised products via stringent regulatory measures.
With export to the EU being difficult and stiff resistance from the US markets on account of an additional duty imposed, IPA imports from China to countries like India have increased significantly from 8% in 2016-17 to 57% in 2019-20.
Lower customs duty rates have also aided the rise in imports. India would still be able to compete for ith the low-cost imports if the duty rates had not been decreased as a result of WTO requirements.
The result is a high import of IPA that continues to fail in several essential metrics, posing a risk to the Indian pharmaceutical industry and the consumer.
All major consuming nations, including the United States, Europe, and China, demand that IPA used in the medication manufacturing process meet their country-specific Pharmacopoeia standards for pharma products sold to those countries.
What is the risk?
Imported IPA that is not Pharmacopeia grade fails on various fronts. From the identification of unsaturated hydrocarbons to UV absorbance rates and rapidly carbonizable material, there is too much at risk for the consumer when it gets used by the pharma industry.
Solvents such as IPA, Toluene, Acetone, and others are imported in bulk and combined inshore tanks at ports. When it comes to comingled solvent storage, source traceability, which is one of the most critical aspects required by the pharmaceutical business, is absent.
As a result, there is always the risk of contamination, which is something that an enterprise dealing with so many human lives cannot afford.
Another area of concern is the rampant use of foreign excipients in the production of pharmaceuticals. Imported excipients, particularly solvents, must be carefully examined by regulators in terms of health hazards and the likelihood of contamination.
Using industrial-grade (non-Pharma grade) IPA carries a lot of danger. As a result, mandating the use of IPA with India Pharmacopeia (IP) certification in pharma is vital, keeping in mind the health of Indian customers and the prestige of the Indian Pharma business.
All this points to the fact that
Indigenous industries need protection from rising imports, particularly from China, which has hurt it. The government can employ tariffs and non-tariff measures to protect the sector. Under the provisions of India’s trade remedies, IPA requires a safeguarding responsibility.
The DGTR has already conducted a safeguard quantitative limitation investigation into IPA imports into India. It is necessary to make efforts such as establishing BIS standards for IPA and including UV absorbance and other key tests in the Indian Pharmacopeia.
The government should educate the public about the dangers of using imported IPA, particularly in the pharmaceutical business. Looking ahead, the domestic segment must band together and rise to the occasion to fulfil the growing demand for IPA.
By Vijaykumar S Singhavi, Ex Drug Inspector, FDA
DISCLAIMER: The views expressed are solely of the author and ETHealthworld does not necessarily subscribe to it. ETHealthworld.com shall not be responsible for any damage caused to any person / organisation directly or indirectly)
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