BIS Standard For IPA Imports: Critical For Securing Pharma Supply Chain

Recently, concerns have been raised about the quality of medicines that are being sold in the Indian market, as the Central Drugs Standard Control Organisation (CDSCO), an apex body responsible for approval of new drugs and clinical trials identified over 50 drugs that failed to meet quality standards. This issue underscores the broader challenge of maintaining stringent quality controls in the pharmaceutical supply chain, not only for finished products but also for critical raw materials like isopropyl alcohol (IPA).

Isopropyl alcohol, commonly known as IPA, is a key chemical that is widely used in the Indian Pharmaceutical Industry. IPA serves as a key solvent in products such as APIs (Active Pharmaceutical Ingredient) that helps in the dissolution of a variety of compounds to enhance the effectiveness of medications. Additionally, IPA also functions as an excipient, helping to stabilize and improve the absorption of drugs. Given its essential role in drug formations, the quality of IPA directly impacts the safety and efficacy of medicines produced in India.

Quality of the input material in the pharmaceutical industry is paramount because it directly affects the effectiveness of the medications produced. Even slight variations or impurities in raw materials like IPA can compromise drug formulations, leading to ineffective treatments or harmful side effects. In an industry where the room for error is extremely limited, ensuring that all input materials meet the highest standards is crucial to protect public health and maintain compliance with stringent regulatory requirements.

In India, Indian Pharmacopoeia Commission, an autonomous institution of the Ministry of Health and Family Welfare sets the standards for medicines in India, ensuring the quality and standards adhering to strict quality control and good manufacturing practices. The domestic IPA industry is known to conduct comprehensive quality control tests at every stage of production and regular analysis is done using advanced techniques such as gas chromatography (GC) to ensure that IPA meets the pharmaceutical industry standards and requirements thereby ensuring the safety of the end user.

However, quality becomes a prominent concern when IPA is imported into India from foreign countries, which often do not abide by pharmaceutical industry standards. This is particularly due to the transportation and storage practices involved. Imported IPA is often shipped in bulk tankers and stored on shared tanks at various Indian ports. These tanks are frequently used for multiple shipments and multiple cargoes from different countries. This co-mingling can compromise the quality and consistency of the product, which is especially critical for the pharmaceutical industry.

Additionally, IPA imports from countries such as China are typically of Non-Pharmacopoeia IPA and substandard technical grade that do not meet the stringent standards of the Indian Pharmaceutical industry. Consequently, this variation in quality renders such imports unsuitable for manufacturing medicines in India as it can compromise the quality and safety of medicines, leading to potential health risks, regulatory issues, and production disruptions. For a country known as the “Pharmacy of the World”, exporting 20% of the global generic drugs, such risks could potentially damage India’s global reputation, resulting in increased global scrutiny, a loss of market share in key international markets.

Despite the lower quality, China continues to dump Non-Pharmacopoeia IPA and substandard technical grade IPA into the Indian market. Furthermore, China should not be taken as a reliable supplier of IPA to India. In FY20, China accounted for 57% of the total IPA imports into India, whereas during the pandemic it came down to just 32% when India was in dire need of IPA for hand sanitizers. Subsequently post the pandemic period, the Chinese stepped up the exports to India to reach the level of 64% during FY 23. This erratic pattern of dumping of technical-grade IPA by foreign countries like China can stifle India’s Pharma supply chain and thereby impact the quality of the end products produced by an $65 billion sector along with risking the end consumer safety.

A necessary and strategic way to tackle substandard IPA imports entering into India could be mandating BIS (Bureau of Indian Standards) certification for both domestic and global producers. This certification will help in ensuring that IPA used in the pharmaceutical industry will meet a consistent level of quality and safety, regardless of the source. Thereby, the probability of contamination or impurities entering the drug manufacturing process will be drastically reduced.

Globally, similar certification standards have been successfully implemented in other countries in order to ensure safety of medicines produced. In the pharmaceutical industry, for example, the FDA (Food and Drug Administration) in the US mandates rigorous quality controls for imports, which has resulted in fewer contamination incidents. In 2018, FDA tightened regulations that required manufacturers to meet stricter quality standards for APIs (active pharmaceutical ingredients) after witnessing that several batches of the blood pressure medication Valsartan being imported from countries like China, contained N- nitrosodimethylamine, a probable cancer-causing chemical. As IPA itself is a key solvent and excipient in the production of APIs and drug formulations, India could use similar standard and quality checks to ensure the quality of this critical raw material is not compromised.

While some may argue that making BIS standard mandatory in respect to IsoPropyl Alcohol  could slow down imports or increase costs, C-DEP’s research found that the actual cost impact on the end consumer would be negligible, between 0.25-1%. This is a small price to pay to ensure public health safety and protect India’s pharmaceutical supply chain from unreliable sources.

Therefore, making the BIS standard mandatory in respect to IsoPropyl Alcohol is not just a regulatory necessity but a strategic imperative to safeguard the quality and reliability of our medicines.  As IPA is a critical input to India’s pharmaceutical industry, maintaining stringent quality control is crucial for ensuring the safety and efficacy of medicines.

 

Views expressed in this article are of the authors. Dr. Jaijit Bhattacharya is the President of Centre for Digital Economy Policy Research; Vrinda Khanna is a policy analyst at C-DEP.