Death by Cough Mixture

India is one of the world’s leading pharmaceutical players supplying key drugs to many countries, particularly in the developing world, including 60 percent of the world’s vaccines. 

 

But recent cough syrup-related deaths are greatly damaging its reputation. 

 

Last year, Indian-made cough syrups were linked to the deaths of 66 children in Gambia. After a Gambian parliamentary enquiry and a World Health Organization investigation, the WHO announced on October 05, 2022, that four cough syrups made by Sonepat, Haryana-based Maiden Pharmaceuticals Limited, were “contaminated” and “substandard”. 

 

In December, the Uzbekistan health ministry reported that 18 children in the country had also died from side effects of cough syrup produced by an Indian pharmaceutical firm, Marion Biotech based in Uttar Pradesh. The WHO issued a warning against two of the company’s cough syrups – and said that laboratory analysis showed both products contained “unacceptable amounts of diethylene glycol and ethylene glycol", chemicals often meant for industrial use. 

 

Gambia and Uzbekistan are not random incidents. In the past, cough syrups have been linked to other mass poisonings of children in India as well as other countries. 

 

This deadly mess can be attributed to India’s longstanding laxness in regulating its booming pharmaceutical industry. 

 

On June 20, Union Health Minister Mansukh Mandaviya came out to declare there is zero tolerance on spurious medicines. He promised an extensive risk-based investigation to ensure the quality of Indian medicines. 

 

And yesterday, the country’s health ministry admitted that they found multiple deficiencies among drugmakers following wide-ranging inspections across the industry, including a lack of raw materials testing. 

 

Indian authorities had stepped up scrutiny of drugmakers in recent months after some cough syrups made in the country were linked to the deaths of at least 95 children overseas. (There was no mention of fatalities in India itself). 

 

The said ministry announced that risk-based inspections of 162 factories and 14 public laboratories found issues including “poor documentation, lack of process and analytical validations, absence of self-assessment, absence of quality failure investigation, (and) absence of internal product quality review”. 

 

They also flagged an absence of raw materials testing, a lack of measures to avoid cross-contamination, an absence of professionally qualified employees, and faulty design of manufacturing and testing areas. 

 

Since then, the government have ordered four drugmakers to cease production of the cough syrups.

Todate, the WHO have red-flagged seven contaminated India-manufactured cough syrups: Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, Magrip N Cold Syrup, AMBRONOL syrup, DOK-1 Max syrup, and Guaifenesin. Four of these have been identified in Gambia, two in Uzbekistan, and one in the Marshall Islands and Micronesia.