Cough Syrups Made In India Allegedly Kill 12 Children In Cameroon- Make In India Campaigns Forget Standards And Responsibility

Cough Syrups causing deaths

Following the tragic deaths of a dozen kids in Cameroon, ‘Made in India’ cough syrups have yet again become a topic of discussion. The cough medicine that officials assume is to blame for the sad fatalities in the central African nation includes a label suggesting that it was manufactured in India.

More than twelve kids have died in Cameroon in recent months, with officials tying the deaths to a cough medication produced in India. Photographs of the pharmaceutical packaging disclosed a license to manufacture identification number that corresponds to Indore-based Riemann Labs in India.

Cameroonian officials are currently investigating the outbreak’s cause and want to examine Naturcold samples linked to the casualties, Filbert indicated in a text message dated June 5. This finding raises the possibility of a third mass mortality connected to imported Indian cough syrups within less than a year’s time. Over 60 children were murdered by drugs produced by two other Indian businesses last year in the Gambia and roughly 20 in Uzbekistan.

In such instances, it was discovered that the syrup prescriptions included diethylene glycol and ethylene glycol, two hazardous substances. Two more Indian businesses, in addition to the ones already mentioned, are suspected of producing similarly contaminated syrups that were discovered in Liberia and Marshall Island, however no injuries have been recorded in those instances.

Toxic cough syrups represent a major danger in recent months, with the UN attributing the sale of poisoned syrups to nine nations thus far. Last year, the medications were connected to the deaths of almost 300 newborns across three continents.

Photographs of a Naturcold drug box reveal a manufacturing authorization number that matches the one held by Riemann Labs Pvt. Ltd., situated in Indore, Madhya Pradesh, India. The images, released by Eko Eko Filbert, a regional health authority in Cameroon, do not identify the maker. Riemann director Navin Bhatia said in an interview that the medications in the photo resemble theirs. However, duplicacy, or when a medicine is disguised to seem like the product of another firm, is rampant in some regions of Africa, according to Bhatia.

They look like ours, but we cannot be sure. There is so much duplicacy there. Based on the quality of our product, it is doubtful. I am 110% sure that my product is not contaminated — what we sent from here. We pay extra attention to quality. Everything is done to ensure safety.

– Navin Bhatia

According to Filbert, the medication was likely smuggled into Cameroon because it was not permitted to be imported there. He said that the origin of the narcotics was unknown to the authorities. By that time, he claimed, 12 kids had already died.

The bottle of cough medicine was manufactured in March 2022, in accordance to the product labeling that can be seen in the photographs. It features the name and emblem of the marketing firm Fraken International, which has a UK address. Emails and LinkedIn messages sent to that address failed to get through to the intended recipients.

According to Bhatia, Riemann last manufactured a batch of Naturcold for Fraken at the beginning of 2022 and sent it to an exporter who claimed to have sent it to Cameroon. He said that Riemann is one of numerous Indian businesses that produced the item.

Glycerin and propylene glycol are important syrup basic ingredients. According to Bhatia, Riemann only purchases these compounds from reputable producers in sealed containers and then has a third-party lab analyze them before usage. He said that they give quality considerable consideration. He additionally added that safety is their first priority and they do everything to ensure it.

Investigations begin

With regard to the Madhya Pradesh Food and Drug Administration, considering Indian drugmakers have gained negative notoriety in barely a year, they have started a preliminary investigation into the matter. An anonymous official added, “Based on your questions, we have sent a team to investigate, and we are waiting for the reports.”

WHO on contamination of cough syrups

In the words of the World Health Organization (WHO), 300 children have passed away in three countries as a result of using contaminated cough syrups.

On the fifth of October in 2022, WHO released a medical product warning for four items, Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup, with a particular emphasis on the Gambia.

It announced a different alert on the sixth of November 2022. This one centered around the nation of Indonesia pertaining to a total of eight items — Termorex syrup (batch AUG22A06 only), Flurin DMP syrup, Unibebi Cough Syrup, Unibebi Demam Paracetamol Drops, Unibebi Demam Paracetamol Syrup, Paracetamol Drops (manufactured by PT Afi Farma), Paracetamol Syrup (mint) (manufactured by PT Afi Farma), and Vipcol Syrup. On the eleventh of January it also released a warning about two products, AMBRONOL syrup and DOK-1 Max syrup, with an eye toward Uzbekistan.

In a statement, the organization stated that during the past four months, several incidences of without a prescription cough syrup for kids being verified or suspected to have excessive amounts of diethylene glycol as well as ethylene glycol contamination had been reported by nations.

According to the report, the pollutants include dangerous substances used as antifreeze along with industrial solvents that should never be present in medications since they may be lethal even in little doses. Despite knowing that no fewer than seven nations have been impacted, WHO continues to maintain that the cases in only three countries are linked to greater than 300 deaths. Children below the age of five have constituted the majority of the fatalities.

The WHO advised all major players in the supply chain for medical supplies to respond immediately and in concert because the instances were not singular. While examinations are still ongoing, Rutendo Kuwana, the WHO team lead for events involving substandard and counterfeit medications, declined to identify the six additional nations the organization is collaborating with.

He cautioned that because tainted barrels of a key component can still be present in warehouses in a few years, contaminated medications might still be available. Both cough syrups and their main component, propylene glycol, have a two-year shelf life.

This is a constant risk, Kuwana added.  According to WHO’s working premise, one or more vendors mingled the less expensive dangerous liquids with the legal chemical in 2021 when the price of propylene glycol increased, Kuwana added. He neglected to address the location of the providers and noted that establishing this was challenging due to hazy supply networks.

Since 2001, the WHO has been recommending against providing cough syrups to kids below the age of five since there is not enough data to know how helpful they might be or what potential adverse reactions that they could cause.

Although the last wave of fatalities was the bloodiest on record, there is evidence of at least five occasions in the past 50 years in which paracetamol and cough medications have been poisoned with toxic substances in nations like India and Panama.

In a statement, WHO calls upon governments and regulatory agencies to identify any of the low-quality healthcare products that have been detected or identified in the aforementioned WHO medical warnings as possible sources of fatalities and illness and remove them from distribution within their corresponding markets; make certain that every one of the medical products in the markets they operate in have been authorized for transaction by the appropriate regulatory bodies and are only available from authorised/licensed vendors; and additionally, in accordance to globally recognized norms and regulations, allocate the necessary resources to enhance and expand based on risk examinations at the manufacturing locations under their control.

Governments ought to strengthen market surveillance, including risk-based aimed examination, for medical products introduced into the markets they regulate, including black markets. They should also implement and uphold laws and other pertinent legal measures, as necessary, to help battle the production, distribution, and/or use of subpar and counterfeit medicines.

The Indian government needs to follow all these recommendations not just to fulfill its responsibilities to other countries but also to safeguard the lives of these young children. Outside of India, such tainted cough syrups that resulted in deaths might have been identified; however, due to several complexity and different health issues, it can be challenging to determine the actual cause of death at times in our country. Even the number of persons who have been impacted by such cough syrups and related medications won’t be known.

The Indian government needs to wake up and start acting to not only to promote “Make in India” but also focus on reiterating the rules and regulations that must be adhered to when developing goods and services here.