Gambia Children Deaths: Is India To Be Blamed? | UnBreak the News with Prema Sridevi | Ep:96

​​The World Health Organisation has sounded a global alert over four cough syrups that an Indian company manufactured. The Indian pharmaceutical company exported these drugs to The Gambia. The four cough syrups are believed to have caused the death of 66 children in the West African nation. The Indian government has asked the WHO to share the evidence of the link between the syrups and the deaths. The Ministry of Health and Family Welfare in India has pinned the responsibility on the importing country, absolving itself of any blame. Who is to be blamed for the death of the 66 children? Prema Sridevi UnBreaks this News for you! 

(Produced below are the abridged version of the transcripts of the video explainer from Episode: 96 | UnBreak the News with Prema Sridevi | Title: Gambia Children Deaths: Is India To Be Blamed?) 

​​The World Health Organisation has sounded a global alert over four cough syrups that an Indian company manufactured. The Indian pharmaceutical company exported these drugs to The Gambia. The four cough syrups are believed to have caused the death of 66 children in the West African nation. The Indian government has asked the WHO to share the evidence of the link between the syrups and the deaths. The Ministry of Health and Family Welfare in India has pinned the responsibility on the importing country, absolving itself of any blame. Who is to be blamed for the death of the 66 children? Let’s UnBreak this news!

The World Health Organisation has sounded a global alert and has said that the death of 66 children in Gambia could be linked to the medicines manufactured by an Indian company Maiden Pharmaceuticals Limited. 

In a press release, the WHO stated: “The four products are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup. The stated manufacturer of these products is Maiden Pharmaceuticals Limited (Haryana, India). To date, the stated manufacturer has not provided guarantees to WHO on the safety and quality of these products. Laboratory analysis of samples of each of the four products confirms that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants. To date, these four products have been identified in The Gambia, but may have been distributed, through informal markets, to other countries or regions.”

The press statement issued by the World Health Organisation on the Indian company Maiden Pharmaceuticals that manufactured the four cough syrups which is believed to have caused the death of 66 children in Gambia | Source: WHO

The Republic of The Gambia is one of the poorest countries in the world. The deaths of the children have completely devastated their families. Who should take the onus for these deaths? 

The Indian government absolved itself from any responsibility and, in a press statement, said: “It is a usual practice that the importing country tests these imported products on quality parameters and satisfies itself as to the quality of the products before the importing country decides to release such products for usage in the country. It has also been informed by the WHO that the certificate of analysis will be made available to the WHO in the near future and WHO will share it with the Indian regulator, which is yet to be done. The exact one-to-one causal relation of death has not yet been provided by the WHO to CDSCO.”

Tedros Adhanom Ghebreyesus, Director General, World Health Organisation addressing a press conference | Photo courtesy: WHO

The Central Drugs Standard Control Organisation (CDSCO) is India’s national regulatory body for pharmaceuticals, cosmetics and all medical devices. In its own words, the CDSCO states: “Under the Drugs and Cosmetics Act, CDSCO is responsible for the approval of Drugs, the conduct of clinical trials, laying down the standards for Drugs, control over the quality of imported Drugs in the country and coordination of the activities of State Drug Control Organisations by providing expert advice with a view of bringing about the uniformity in the enforcement of the Drugs and Cosmetics Act.”

While the Ministry of Family and Health Welfare in India speaks of the responsibility of the importing country (Gambia), it is silent about the role CDSCO plays in regulating the affairs of the export of drugs to foreign nations. Below is a certificate issued by CDSCO to a company in Telangana that wanted to export a few drugs to the European Union (EU).

A copy of the certificate issued by the CDSCO to a Telangana-based company for the export of drugs to the European Union (EU) | Source: CDSCO

The drugs were manufactured at a plant in Medchal in Telangana. As is evident from the document, the drug regulator had conducted unannounced inspections of the plant in Telangana to see if the drugs had conformed to the quality standards so that they could be sent to the European Union for human consumption. 

The document related to the certification reads: “The manufacturer is subject to regular, strict and transparent controls and to the effective enforcement of Good Manufacturing Practice, including repeated and unannounced inspections, so as to ensure the protection of public health equivalent to that in the EU… The Written Confirmation will be withdrawn in the event of non-compliance with Standards… In the event of any drug found not of standard quality, the same shall be reported to this office within seven days of receipt of the report.” 

In the case of the Telangana-based company, the CDSCO did quality checks to ensure that it complied with the European Union (EU) standards. It is still unclear if the CDSCO applied the same yardstick in the case of Maiden Pharmaceuticals, which had exported the drugs to Gambia.

In the past, Maiden Pharmaceuticals was in the thick of controversy over their substandard quality of production of drugs. According to media reports, their drugs were found to be substandard during lab tests in Kerala on at least five occasions in the past nine months. 

Critics have asked the government why the company was allowed to operate when it had repeatedly violated manufacturing standards. The WHO has indicated that the pharma company may have sold the drugs exported to Gambia to other countries as well through informal markets. The Indian government, however, has quickly admitted that Maiden Pharmaceuticals has manufactured and exported products only to Gambia. The Indian authorities have stated that the samples of all four drugs have been collected and sent for testing to the Regional drug Testing Lab in Chandigarh by the CDSCO.

Meanwhile, the pharma company has claimed on its website that it has a production capacity of 600 million capsules, 18 million injections, 0.3 million tubes of ointments, 2.2 million syrups and 1200 million tablets. The company not just sells its drugs to Asia, Africa and Latin American countries but also to Indians. The enormity of the company’s production capacity and the non-conformity of manufacturing standards of drugs is a matter of serious global public health concern.

In the past, the Bihar government had blacklisted Maiden Pharmaceuticals for supplying substandard drugs in 2011. As per the Bihar government’s official order, the company had supplied ‘spurious’ and ‘substandard’ medicines in the state several times.

The Indian drug regulator has kicked off a probe against the company. But the question remains if the lives of 66 children in Gambia could have been saved if the Indian drug regulator had acted against the pharma company when states in India had raised the alarm.