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Industry keen to find mechanism to ascertain industrial & pharmacopoeial grade of ingredients in cough syrups
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Nandita Vijay, Bengaluru
June 30 , 2023
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Indian pharma now sees the need to find a mechanism to immediately ascertain industrial and pharmacopoeial grade of any active ingredient that goes into the manufacture of cough syrups.
This comes close on the heels of the recent media report on the Noida-based Marion Biotech, the manufacturer of cough syrups, containing a toxic industrial-grade ingredient rather than the authentic pharmaceutical version that led to the fatality of 18 children in Uzbekistan in December 2022.
The latest investigation, according to a media report, stated, “The company, Marion Biotech, bought the ingredient: propylene glycol (PG) from trader Maya Chemtech India. But, Maya did not have a license to sell pharmaceutical-grade materials and ‘dealt in industrial-grade only,’ according to a source at the firm with knowledge of the Marion investigation.”
In its early inspection during December 2022, India’s drug regulatory CDSCO stopped the manufacture after the Ministry of Uzbekistan's allegation that the cough syrup manufactured by the Indian company resulted in the tragic end of 18 children.
Upset over the news about the contaminated paediatric cough syrup, Harish K Jain, President, Federation of Pharmaceutical Entrepreneurs (FOPE) and Karnataka Drugs and Pharmaceutical Manufacturers Association (KDPMA) said “This act looks like more of omission, negligence and failure of management oversight. This kind of incident once again underlines the fact that every pharma company in the country needs to put in place a robust quality management system. Having said that, India also needs regulatory surveillance on manufacturing, distribution and supply chain of not only APIs (active pharmaceutical ingredients), but also excipients.”
Agreeing with Jain was Kaushik Desai, Secretary General, International Pharmaceutical Excipients' Council of India (IPEC India) who pointed out, “Such findings disturb the common man. The industry shall respond to clear the misconception of using only standardised PG in liquid products with more focus on paediatric products. While the regulatory body will do their bit in ensuring that the excipient like PG is used of standard quality, the industry also needs to initiate development efforts to replace PG in their liquid products wherever possible to avoid use of industry grade instead of pharmacopoeial grade by vested interested parties and educate people at large.”
“We need to put in a place a mechanism to instantly ascertain industrial grade and pharmacopeial grade of any active ingredient that goes in the manufacture of cough syrups or any drug to prevent such catastrophic incident,” added Desai.
There are guidance documents available with IPEC India on the supply certification and GMPs exclusively for excipients which could be an ideal reference tool in ensuring quality standards. This is because those supplying industrial grade of the ingredient in cough syrups and other liquid products may not be only propylene glycol, ethylene glycol and diethylene glycol in pharmaceutical grade. It definitely mandates the need to specify the source of every ingredient when submitting for regulatory clearances and export documentation. While it may be a challenge to do this, yet this information on the source of ingredients is critical to prevent any untoward tragedy, said Desai.
In October 2022, after 66 children succumbed to the spurious quality of four cough syrups had the Karnataka drugs control department insisted that all the cough syrup manufacturers dealing in ethylene glycol and diethylene glycol will need to procure solvents like glycerin and propylene glycol complying to pharmacopeia standards directly from manufacturers under para 10 of the Schedule M of the Drugs & Cosmetics Act, 1945.
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