Non-IP grade Iso Propyl alcohol usage puts consumers at risk

Jeopardising health & well-being

• Out of 170,000 MT of IPA consumed by Indian Pharma Industry, only about 12% is pharma grade meeting Indian and other Pharmacopoeia Standards

• The rest is non-pharma grade

• Section 16 of the second schedule of drug and cosmetics Act mandates the usage of IP specs for pharma application

• But the ground reality remains that majority of IPA consumed in Pharma industry is purchased as a non-IP grade

Hyderabad: A whopping 88 per cent of Iso Propyl Alcohol consumed by the Indian Pharma Industry as the raw material to produce pharma drugs, is non-IP (Indian Pharmacopeia) grade, putting the health and well-being of Indian consumers and the reputation of Indian Pharma industry at risk.

Iso Propyl Alcohol has its application embedded, not only in the pharma industry but also in the hand sanitizer segment, which is so widely and commonly used by Indian consumers at home, offices, cinema halls, shopping malls, airports, railway stations, education institutes, and hotels and restaurants.

It is observed that out of 170,000 MT of IPA consumed by the Indian Pharma Industry, only about 12 percent is pharma grade meeting Indian and other Pharmacopoeia Standards, and the rest is non-pharma grade. According to Vijaykumar Singhavi, an industry and a regulatory expert, who was formerly a Technical Officer at FDA, Maharashtra state, "Section 16 of the second schedule of drug and cosmetics Act mandates the usage of IP specs for pharma application, but the ground reality remains that majority of IPA consumed in Pharma industry is purchased as a non-IP grade."

"The non-pharma grade IPA used in the pharmaceutical industry may fail to meet various critical parameters covered in various Pharmacopeia Standards, such as UV Absorbance Test, Benzene & R Substance, Non-Volatile Residue / Substance, Acidity or Alkalinity", Singhavi said adding: "The failure to meet these parameters, eventually leads to usage of substandard material and ultimately compromises the quality of the drug."

Isopropyl alcohol (IPA) can be manufactured by two alternative routes using propylene or acetone as raw materials. Most global players in the USA and Europe use propylene as feedstock to produce IPA, whereas many Chinese and Korean producers use acetone as feedstock to produce IPA.

While IPA produced from the propylene route may have some normal propyl alcohol and acetone in traces in the final product but do not pose any issue for pharma applications. Whereas IPA produced from acetone is likely to have benzene, as acetone is a co-product in phenol production for which benzene is a feedstock along with propylene. This could pose challenges for pharma producers, Singhavi said. Even the imported IPA, stored in commingled tanks at Indian ports may not meet the purity standards prescribed by various Pharmacopoeia standards. Usage of such imported IPA may pose a risk to Indian consumers and the reputation of the Indian Pharma industry, Singhavi said.