DCGI calls out WHO for 'prematurely' blaming Maiden Pharma for cough syrup linked deaths in Gambia

The Indian health authorities halted production at Maiden's main factory in Sonepat near New Delhi in October after a WHO report said the company's cough and cold syrups might be connected to the deaths of 69 children in Gambia this year.

However, in the letter to the WHO dated December 13, Somani said that tests on samples of Maiden's products had "been found to be complying with specifications" and no ethylene glycol or diethylene glycol was detected in them.

PTI reports that the Central Drugs Standard Control Organisation (CDSCO) in coordination with State Drug Controller, Haryana had carried out a joint investigation of Maiden Pharmaceuticals in Kundli, Sonepat to ascertain the facts that allegedly led to the death of 66 children in the West African country.

During the investigation, it was revealed that the State Drug Controller, Haryana had given licenses to the company for manufacture of four drugs for export only, Minister of State for Chemicals and Fertilisers Bhagwanth Khuba said in a written reply in the Rajya Sabha on December 13.

The four drugs are Promethazine Oral Solution BP, KOFEXMALIN Baby Cough Syrup, MaKOFF Baby Cough syrup and MaGrip n Cold Syrup. These drugs are not licensed for manufacture and sale in India and are not marketed or distributed here, he added.

"Further, control samples of the aforementioned drugs were drawn and sent for test and analysis to Regional Drug Testing Laboratory, (RDTL) Chandigarh by the investigating team. As per the report of the Government Analyst, the samples have been declared to be of standard quality," the minister said.

As per the reply, the samples were also found negative for both Diethylene Glycol (DEG) and Ethylene Glycol (EG).

The U.N. agency said in October that its investigators had found "unacceptable" levels of diethylene glycol and ethylene glycol, which can be toxic and lead to acute kidney injury, in the products manufactured by Maiden.

Taking note, the Haryana State Drugs Controller had stopped all the manufacturing activities of Maiden Pharmaceuticals at Sonepat.

Also Read: 5 Days After WHO Alert, Maiden Pharma Breaks Silence On Cough Syrup Deaths In Gambia

The Indian government had formed a technical committee of subject experts to examine and analyse the details. Medical Dialogues team had earlier reported that the four-member committee, headed by Y K Gupta, vice-chairperson, the standing national committee on medicines, requested specific information from WHO on further details essential to establish causality.

Also Read: Expert Committee Holds First Meeting To Examine WHO Claims On Maiden Pharma Case

Lately, the Drugs Controller General of India (DCGI) has confirmed that the cough syrup samples taken from the plant weren't found to be contaminated, adding that the results of the tests had been sent to a panel of experts for further action.

Somani, in his letter stated, "India has been committed to rigorous monitoring and oversight to ensure that the highest standards of manufacture are maintained in quality control of drugs and cosmetics. In the aftermath of the alerts received from WHO regarding the incidents in Gambia, an independent inspection was conducted on the premises of Maiden Pharmaceuticals, the firm in question. A show cause notice was issued to the firm under provisions of India's Drugs and Cosmetics Act for violation of various Good Manufacturing Practices (GMP), and for not producing the complete records of manufacturing and testing as per the extant rules. Considering the observations made during the inspection, the manufacturing activities of the firm were stopped forthwith in the public interest CDSCO has already Informed WHO in this regard. It is to emphasize that the above action was taken exclusively for GMP violations by the firm."

"Further, WHO had been informed that the samples of these 04 products in question were drawn and sent for testing to Government Laboratory as per extant rules. As per the test reports received from the Government laboratory, all the control samples of the 04 products have been found to be complying with specifications," the letter added.

News agency ANI reports that the letter also noted that all the alerts and the communications received from the onset of the Gambia have contained references to the deaths of the children and have been formulated in such a manner as to hint that cough syrup consumption was the primary cause of the mortality.

It further stated that the previous email, dated September 29, 2022, contains "...whose cause of death, or a significant contributing factor was suspected to be the use of medicines which may have been contaminated with Diethylene Glycol or Ethylene glycol."

"It is clear that perhaps premature deduction was drawn on September 29th itself regarding the cause of death. Every subsequent alert or publication from the WHO only seems to be a reaffirmation of this deduction, without waiting for independent verification," the letter said.

The drugs officer also highlighted in his letter that the statement issued by the global agency in October this year was 'amplified by global media', which led to a narrative being built internationally targeting the quality of Indian pharmaceutical (pharma) products.

"This, in turn, has adversely impacted the image of India's pharma products across the globe, and caused irreparable damage to the supply chain of pharma products, as well as the repute of the national regulatory framework, over an assumption that has yet not been substantiated by WHO or its partners on the ground," Somani said in a strongly worded letter.

The drug regulator has been writing to the WHO continuously ever since the incident asking them to share the details. However, in the letter he said that in the present communication WHO has declared its mandate to be of "identification of global public health risks alone" and has announced that the responsibility of "establishment of causality of deaths" rests with the countries in question.

"This is a strangely contrary position to the one adopted in the earlier communications where WHO had affirmed its commitment to provide granular details of the incident on causal relation. It is also a departure from the inflections expressed in the statements issued earlier by the WHO," the letter said.

As per a recent media report in The Economic Times, the drug regulator has asked the WHO to provide details to the technical committee of subject experts constituted by the government to arrive at the conclusion based on all the facts and evidence available. "We would be more than willing to consider permitting WHO representatives to interact with this technical committee," the letter said.

Meanhwhile, commenting on the latest development, Maiden Managing Director Naresh Kumar Goyal told Reuters, "I have full faith in Indian regulatory and judiciary processes. I have not done anything wrong."

"We will now try to request the authorities to reopen the factory. But I don't know when that will happen. We are still waiting," Goyal added.