Indian Pharmacopoeia (IP) certification should be made mandatory for isopropyl alcohols (IPA) used in pharma applications by the Union Government, as usage of imported IPA is fraught with risks. IPA, commonly called isopropanol, is a colourless, flammable liquid with a strong odour.
Indian IPA manufacturers allege that cheap imported IPA, fails to meet various critical parameters covered in Pharmacopeia Standards such as UV absorbance test, identification of unsaturated hydrocarbons and rapidly carbonizable material. They further added use of such sub-standard non-pharma grade IPA adversely affects the quality of the drug exposing millions of Indian consumers to severe health hazards.
It also jeopardises the reputation of the country’s pharma industry. Indian government is yet to impose stiff rules to curb the use of imported excipients and solvents including IPA by the pharma industry. Keeping in mind the health of Indian consumers as well as the stature of the Indian pharma industry, it is critical to mandate the use of IPA with Indian Pharmacopeia (IP) certification in pharma. Vikas Biyani [Retd. Asst. Commissioner, Maharashtra FDA] said Isopropyl alcohol is a key solvent for multiple drugs that carries a similar risk of contamination and health hazard, hence requiring urgent attention.”