Maiden Pharma Cough Syrup Row

It was brought up once more in Gambia that Maiden Pharmaceuticals' cough syrups may have contributed to the deaths of 70 children there.

Parliamentary committee suggestion 

According to the BBC, a parliamentary committee in the Gambia has suggested that "an Indian cough syrup maker suspected of killing at least 70 children in the West African country" be prosecuted.

It was impossible to contact the Union Ministry of Health for comment on the situation. It was also impossible to contact Maiden Pharma for comment.

The Gambian parliamentary committee, according to the article, agreed after weeks of inquiry that authorities should take strong actions, including banning all Maiden Pharmaceutical products in the nation and pursuing legal action against the company.

Tested cough syrups 

The results demonstrate that the four cough syrups tested—Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup—were tainted with diethylene glycol and ethylene glycol.

Letter to WHO 

In sharp contrast, the Indian regulator discovered the opposite when it examined samples of cough syrup from Maiden Pharma's Sonipat plant. In a letter to WHO, the Drugs Control General of India (DCGI) V G Somani stated that samples of the four cough syrups manufactured by Maiden Pharma that were supplied to government laboratories for testing met all requirements.

Excipients 

The Indian regulator had stated that DEG and EG were not found in these products, hence these were not discovered to be tainted. Propylene glycol was one of the excipients purchased from Goel Pharma Chem in Delhi, which had brought them over from South Korea.

Glycerine was obtained from Goel Pharma Chem once more; Adani Wilmar had originally provided it. Additionally, it was discovered that excipient samples taken from Maiden Pharma's manufacturing facility comply with standards.

Maiden pharma plant 

However, Indian officials decided against reopening the Maiden Pharma plant, claiming that the closure was required owing to violations of good manufacturing standards for food (GMP). A joint team made up of inspectors from the state FDA and CDSCO will visit the plant for another check before it can be permitted to be reopened, according to the Haryana state regulator.

Analysis of WHO 

However, according to the WHO, samples examined in Ghana and Switzerland were determined to be tainted.

A WHO representative told Business Standard that tests conducted by laboratories under contract with the organization in Ghana and Switzerland on products thought to be cough syrups from the Gambia revealed excessive levels of ethylene glycol and diethylene glycol. These tainted syrups are harmful and never should be included in medicine.

"One of WHO's responsibilities is to publish global notifications regarding potential threats. WHO says it stands by the decisions made.