Maiden Pharma's cough syrups, under WHO scanner, not sold in India: Sources

Delhi-based Maiden Pharmaceuticals, whose cough syrups have come under the scanner of the World Health Organization and the Indian regulator for contamination and linked to the deaths of 66 children in the West African country of Gambia, does not market these products in India, trade sources said. Rajiv Singhal, general secretary of the All India Organisation of Chemists & Druggists (AIOCD), said the body had reached out to the company, which stated this.
 

“The company told us these were only for export markets. We have also asked the DCGI (drug controller general of India) for directions on what to do next,” he added.
 

Moreover, reports suggest the company claimed it would recall the products from Gambia after it received instructions from the government to do so.
 

In what can be a blow to India’s image as the “pharmacy of the world”, cough syrups manufactured by the Indian company were found to contain “unacceptable” amounts of diethylene glycol and ethylene glycol, which can be toxic and can cause kidney damage.
 

Meanwhile, the Indian regulator is awaiting evidence of links between the cough syrups and the deaths in Gambia.
 

The Central Drugs Standard Control Organisation (CDSCO) has started investigation to ascertain the facts in association with the state drug controller of Haryana, where the company has its manufacturing plant. It makes products like paracetamol, common cough syrups, medicines for dysentery, etc.
 

On September 29, the WHO informed the DCGI about the deaths in Gambia and suspected links with Maiden Pharma.

“The CDSCO took up the matter immediately with the Haryana State Regulatory Authority, under whose jurisdiction the drug manufacturing unit of Maiden Pharmaceutical, Sonepat, is located,” the Union Health Ministry said on Thursday. From the preliminary enquiry by the CDSCO, it had been found that Maiden Pharma is a manufacturer licensed by the state drug controller for products such as Promethazine Oral Solution BP, Kofexnalin Baby Cough Syrup, MaKoff Baby Cough Syrup and MaGrip n Cold Syrup, it said. It has permission to make these products for export only, the Union government said.
 

“The company has manufactured and exported these products only to Gambia,” it added.
 

Meanwhile, reports suggest Maiden Pharma officials indicated they might recall the products upon government orders, and they were awaiting the results of government analysis.
 

Calls made to Maiden Pharma went answered, and an email did not get a reply till the time of going to press.
 

Haryana health Minister Anil Vij told reporters that the government has sent samples of the four cough syrups in question to the Central Drugs Laboratory, Kolkata, for testing.
 

Promoted by Naresh Kumar Goyal, Maiden Pharma clocked a Rs 38.07 crore turnover in FY21 with an Ebitda of Rs 91.41 lakh and profit after tax of Rs 5.82 lakh, showed data from Tofler.  
 

Sources say that the company had come under the scanner of the Jharkhand drugs controller for allegedly selling sub-standard paracetamol syrup in 2013-14.

Pharma industry insiders said most contamination-related problems arose due to solvents.

“At times, solvents unfit for human consumption make their way into the pharma supply chain. The manufacturer needs to have robust quality assurance and control systems in place to pick this up,” said a senior executive of an Ahmedabad-based firm.

Legal experts say that if a causal link between the deaths of children and the cough syrup are established, then the company can be prosecuted under the Drugs and Cosmetics Act in India.    

About Maiden Pharmaceuticals 

• Promoter Naresh Kumar Goyal; Vinod Kumar and Vivek Goyal are directors 
• Makes paracetamol, common cough syrups, dysentery medicines 
• Established in 1990

Diethylene glycol poisoning events

1972: DEG poisoning in Chennai

2020: 11 children from Jammu died in PGIMER Chandigarh

1937: 100 adults and children died in US

Source: The Truth Pill: The Myth of Drug Regulation in India by  Dinesh S Thakur & Prashant Reddy T (book releases on October 10, Publisher: Simon & Schuster India)