Isopropyl alcohol: CDSCO to make IP mandatory in Pharma

The health ministry instructed the central drug regulatory authority to take necessary steps to address the issue.

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CDSCO DCGI FDA

Last Updated on September 18, 2021 by The Health Master

The Central Drugs Standard Control Organization (CDSCO) is planning to make Indian Pharmacopoeia (IP) mandatory for all isopropyl alcohol used in pharma applications.

It has written to state and Union territory drugs controllers twice seeking their inputs on making IP compulsory for isopropyl alcohol used in drug application.

The CDSCO move comes after a representation from Deepak Fertilizers and Petrochemical Corporation Limited (DFPCL), a leading manufacturer of industrial chemicals in India. DFPCL is the largest and sole manufacturer of isopropyl alcohol in the country catering to 40 per cent of domestic demand.

DFPCL in its representation to the Union health and family welfare ministry stated that pharmaceutical manufacturers are not using IP grade isopropyl alcohol in drug application. This in turn impacts the quality of pharmaceutical products.

However, monograph of isopropyl alcohol is included in Indian Pharmacopoeia as pharmaceutical aid (solvents).

Besides its use in pharma application as solvent, isopropyl alcohol is a key ingredient in hand sanitizer manufacturing.

Isopropyl alcohol is a colorless, flammable chemical compound with a strong odor. It dissolves a wide range of non-polar compounds. It also evaporates quickly, leaves nearly zero oil traces, compared to ethanol, and is relatively non-toxic, compared to alternative solvents. Isopropyl alcohol is esterified to give isopropyl acetate, another solvent.

The health ministry instructed the central drug regulatory authority to take necessary steps to address the issue.

Acting on the health ministry’s instruction, CDSCO decided to make IP mandatory for all isopropyl alcohol used in pharma applications.

It dashed off a letter to state and UT drugs regulators on August 3, 2021seeking their inputs in regard. Due to lack of responses from state and UT drugs controllers, CDSCO again has written to them seeking their comments on the issue on September 13, 2021.

All state and UT drugs controllers are once again requested to submit the information to CDSCO at the earliest, said Dr VG Somani, drugs controller general of India.

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