The Union Government should make Indian Pharmacopoeia (IP) certification mandatory for isopropyl alcohols (IPA) used in pharma applications as usage of imported IPA is fraught with risks. 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.
IPA, commonly called isopropanol, is a colourless, flammable liquid with a strong odor. It is used in the manufacture of a wide variety of industrial and household chemicals and finds major applications in the production of bulk drugs and drug formulations which are vital in the pharma manufacturing process. Vikas Biyani, Retd. Asst. Commissioner, Maharashtra FDA, said, “Indian pharmaceutical sector consumes roughly 170,000 MT of the overall India IPA demand of around 240,000 MT in FY21. Of the 170,000 MT of IPA consumed by the pharma Industry, only about 12 % is pharma grade, meeting Indian and other Pharmacopeia Standards. The rest is non-pharma grade”.
