Government should make IP certification mandatory for IPAs used in pharma industry

Vikas Biyani, Retired Assistant Commissioner, Maharashtra FDA, explains why it is critical to mandate the use of IPA with the Indian Pharmacopeia (IP) certification in pharma

The 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.

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 the use of such sub-standard non-pharma-grade IPA that 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 odour. It is used in the manufacturing 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. It is also used as a common ingredient in products such as hand sanitisers, antiseptics and disinfectants.

Indian pharma 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 per cent is pharma grade, meeting Indian and other pharmacopeia standards. The rest is non-pharma grade.

Incidentally, solvents such as IPA, Toluene, Acetone and others are imported in bulk and stored in a commingled fashion in shore tanks located at Kandla, Vizag, and other ports. These solvents get contaminated at the various handling stages starting from loading at the port to getting delivered to end-users. The contamination, industry players claim, either comes from tank cars or dissolutions of lacquers from the inside coating of metal vessels.

As a result, imported IPA stored in commingled tanks at Indian ports does not meet the pharmacopoeia standards. If used to produce medicines, they contaminate the drug, change its quality and deteriorate its shelf life. Therefore, imported excipients, especially solvents, must be carefully examined by regulators for traces of contamination. Traceability of source, which is one of the important parameters carefully pursued by the pharma industry, is completely missing when it comes to comingled storage of solvents

Even though Section 16 of the second schedule of The Drugs and Cosmetics Act mandates IP specifications for pharma application, IP standards strengthened by the Indian Pharmacopoeia Commission (IPC) and FDA authorities of states like Goa, Maharashtra and Uttarakhand have directed drug manufacturers to use only pharma-grade IPA, the ground reality is different. The Indian pharma industry is using IPA that does not fulfil pharmacopoeia criteria which is dangerous and hazardous to health.

It may be noted that nations, including the US, Europe and China demand that IPA used in the drug manufacturing process meet their individual pharmacopoeia criteria for medications exported to these countries. China Food and Drug Administration (CFDA) too has exhibited concern about the quality of drugs entering Chinese soil by imposing stringent regulations not only on the final products, but also on all ingredients including excipients. Indian pharma companies like Aurobindo Pharma, Alembic Pharma, Cipla and Dr Reddy’s Laboratories planning to tap the large Chinese market will have to get all ingredients, needed for the production of drugs and related ingredients such as APIs, intermediates and excipients, approved by CFDA compulsorily.

Indian government is yet to impose stiff rules to curb the use of imported excipients and solvents including IPA by the pharma industry.

The recent embarrassing incident in Gambia due to contaminated cough syrup, originating from an Indian company, highlights how contaminated raw materials are being used by the pharma industry, severely compromising the quality of drugs and risking the lives of millions not only in India, but globally too.

This incident has also tarnished India’s reputation as a pharmacy to the world. In this particular case, the World Health Organization (WHO) has already issued global alerts against the Indian company. In response, various FDA authorities such as Maharashtra and Karnataka have also issued circulars stating that all pharma manufacturers need to procure solvents complying to pharmacopeial standards directly from manufacturers. While actions are now warranted, a proactive approach would have prevented such an incident. Isopropyl alcohol is a key solvent for multiple drugs that carries a similar risk of contamination and health hazard, hence requiring urgent attention.

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 the Indian Pharmacopeia (IP) certification in pharma.

Indian Pharmacopoeia standardsIP certificationIPAisopropyl alcoholsMaharashtra FDAVikas Biyani
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  • soundos

    Good article , thanks!!!!!!!