According to a show cause notice issued to the company, the company was unable to produce a log book of the equipment and instruments used to manufacture and test the drugs in question.
A week after the World Health Organization reported that up to 66 children in the Gambia may have died after consuming Indian-made cough syrups, the Haryana government has halted all drug production at a plant linked to it. Major irregularities were discovered at the facilities of Maiden Pharmaceuticals, the syrups’ Haryana-based manufacturer. The matter has been growing indeed.
“Sonipat’s pharmaceutical company sent samples of three WHO-recommended drugs to the Central Drug Lab in Kolkata. The reports have not yet arrived; action will be taken once they do “Haryana Health Minister Anil Vij told ANI that a joint inspection by the Central and Haryana state drug departments discovered around 12 manufacturing flaws.
“With this in mind, it has been decided that total production will be halted,” Mr. Vij added.
According to a show cause notice issued to the company, the company was unable to produce a log book of the equipment and instruments used to manufacture and test the drugs in question.
The batch numbers of potentially hazardous chemicals obtained for the manufacture of cough syrups have not been disclosed. Propylene Glycol, Sorbitol Solution, and Sodium Methyl Paraben are among the chemicals.
The company failed to validate the processes and methods used in the production of the syrups in question. A batch of propylene glycol that the company tested and declared to be of “Standard Quality” failed in several ways.
Investigators of the Haryana cough syrups in question received no in-process testing reports.
There are discrepancies between the date of manufacture and the product permission granted.
The Haryana State Drugs Controller has given the company seven days to respond to its show cause notice, after which the company’s manufacturing license may be suspended or cancelled, and further legal action may be taken.
The medicines, according to WHO Director-General Tedros Adhanom Ghebreyesus, were cough and cold syrups manufactured by Maiden Pharmaceuticals Limited. “The WHO is conducting additional investigations with the company and regulatory authorities in India,” he said, adding that the loss of young lives as a result of the products was “beyond heartbreaking for their families.”
Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup are the four products. According to the World Health Organization, the manufacturer “has not provided guarantees to WHO on the safety and quality of these products to date.”
While the contaminated products have so far only been found in The Gambia, the WHO chief believes they may have been distributed to other countries. To prevent further harm to patients, WHO has recommended that all countries detect and remove these products from circulation.
Substandard medical products, according to WHO, are those that do not meet their quality standards or specifications. As a result, they are “out of specification,” according to the health organization.
Each of the four products contained unacceptable amounts of the contaminants diethylene glycol and ethylene glycol, according to laboratory analysis of samples.
According to the WHO, diethylene glycol and ethylene glycol are toxic to humans and can be fatal if consumed.
“Toxic effects may include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury, which may result in death,” the warning stated.
In July, medical officers in Gambia issued an alert after dozens of children became ill with kidney problems. The deaths perplexed doctors until a pattern emerged: children under the age of five became ill three to five days after taking a locally sold paracetamol syrup.
Mustapha Bittaye, the Gambia’s director of health services, said similar problems had been detected in other syrups but that the ministry was awaiting confirmation of the results.
He stated that the number of deaths has decreased in recent weeks and that the sale of Maiden Pharmaceuticals products is now prohibited. However, he claims that some of the syrups were still being sold in private clinics and hospitals until recently.
According to its website, Maiden Pharmaceuticals manufactures medicines in India, which it then sells both domestically and to countries in Asia, Africa, and Latin America.
“I was shocked to hear…” Maiden Pharma finally speaks out about cough syrup deaths in the Gambia.
Maiden Pharmaceuticals, an Indian pharmaceutical company, expressed shock on Saturday following media reports of 66 children dying in the Gambia after consuming cough syrup manufactured by them.
“We are shocked to hear the media reports regarding the deaths and deeply saddened on this incident,” the pharma company said in an exclusive statement to ANI. “However, we received the official information from our agent in the Gambia on October 5, 2022, and on the subsequent date, a World Health Organization alert was issued against us.”
Maiden Pharmaceuticals has come under scrutiny after 66 children died in the Gambia after consuming cough syrup manufactured in India.
“We have been in the field of medicines for over three decades and have been diligently following the protocols of the health authorities including Drugs Controller General (India) and the State Drugs Controllers, Haryana,” said company Director Vivek Goyal in an official statement.
He also stated that they have valid drug approvals for the export of the products that his company does not sell in the domestic market. He also stated that his company obtains raw materials from certified and reputable suppliers.
“The government agencies visited our factory on October 1 and 3, October 6 and 7, and samples were drawn by the Central Drugs Standard Control Organization (CDSCO) along with all relevant documents in question in the presence of our directors,” Goyal said in a statement.
After WHO issued a medical alert, drug regulators collected samples of cold and cough syrup from Haryana-based Maiden Pharmaceutical’s manufacturing facility in Sonipat, and results are expected soon.
“The samples were drawn by CDSCO officials and we are awaiting the results,” he added. “Because the matter is already pending investigation and subjudice, we cannot comment on any other issues and will update you in the future as and when we receive the information.”
The WHO issued an alert on Wednesday regarding four cough and cold syrups manufactured in India by Maiden Pharmaceuticals. The same cough and cold syrups have also been linked to the deaths of 66 children in the Gambia, according to WHO.
According to sources, the preliminary investigation revealed that Maiden Pharmaceutical Limited, Sonipat, Haryana, is a manufacturer licensed by the State Drug Controller for the products in question and has manufacturing permission for these products. So far, the company has only manufactured and exported these products to the Gambia. (ANI)
Who is accountable for the quality of Indian pharmaceutical exports?
The World Health Organization said on Wednesday that the deaths of 66 children in The Gambia may have been caused by contaminated cough and cold syrups manufactured in India by Delhi-based Maiden Pharmaceuticals.
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WHO said in a medical product alert covering four India-made paediatric syrups that laboratory analysis revealed “unacceptable” amounts of diethylene glycol and ethylene glycol as contaminants, which can be toxic and cause acute kidney injury.
According to WHO, all batches of these products should be considered unsafe until they are tested by the appropriate national regulatory authorities.
The products may have been distributed elsewhere through informal markets, but the WHO said in an alert advising regulators to remove these syrups from the market that they had only been identified in The Gambia.
Maiden Pharma, which has two manufacturing plants in Haryana, said it is not currently selling any products in India.
According to reports, India is awaiting more information from the WHO because the UN health agency has yet to provide the precise “one-to-one causal relationship of deaths.”
According to WHO, information received from India’s Central Drugs Standard Control Organization indicated that the contaminated medications were only supplied to The Gambia by the manufacturer.
The WHO’s Medical Product Alerts are intended to alert member countries and the general public to the existence of potentially dangerous medical products, as well as to encourage increased vigilance and appropriate regulatory action.
So far, in 2022, it has issued five such alerts, 11 in 2021, seven in 2020, and 11 in 2019.
The majority of the warnings concern falsified medical products that intentionally or fraudulently misrepresent their identity, composition, or source.
The deaths of 66 children in the Gambia have harmed India’s image as a “world pharmacy.”
India is the world’s third-largest producer of medicines and the largest supplier of generic drugs.
India meets more than half of Africa’s generics demand, roughly 40% of generic demand in the United States, and 25% of total medicine in the United Kingdom.
Indian drug and pharmaceutical exports totaled $24.6 billion in FY22, up from $22.4 billion the previous year.
So, who is in charge of ensuring the quality of Indian pharmaceutical exports?
According to Darren Punnen, Leader, Pharma & Life Sciences Practice, Nishith Desai Associates, manufacturing standards for export-only products are regulated by India. Product standards are not always regulated under Indian law. GMP examines machinery, personnel, competency, and processes.
India’s pharmaceutical industry is currently worth $50 billion. The domestic pharmaceutical industry is comprised of approximately 3,000 drug companies and 10,500 manufacturing units.
It also has the most US Food and Drug Administration (or FDA) compliant pharma factories outside of the US.
As a result, several poor manufacturing practices in the industry came to light, which initially harmed many firms but eventually led to the adoption of better measures, allowing the sector to penetrate many markets and achieve global credibility.
Are there any systemic issues affecting the pharmaceutical manufacturing sector that could result in the production of subpar products?
According to Mahesh Zagade, former Commissioner of the Maharashtra Food and Drug Administration, diethylene glycol is frequently found in syrups. The purity of raw materials and finished products is tested. However, regulatory oversight is lacking in ensuring that these provisions are followed. He claims that central government oversight is also inadequate.
Only after the investigation into the Gambia incident is completed will we know who is to blame. If the manufacturing plant in India is found to have made mistakes, both the state and central drug regulators may be held accountable. Meanwhile, the Indian pharmaceutical industry’s reputation may have already suffered.
Deaths Caused by Cough Syrup
On September 29, WHO informed the Central Drugs Standard Control Organization (CDSCO) that they were providing technical assistance and advice to Gambia, where children had died and the use of medicines was suspected to be a contributing factor (Promethazine Oral Solution BP, KOFEXNALIN Baby Cough Syrup, MaKOFF Baby Cough Syrup and MaGrip n Cold Syrup).
Maiden Pharmaceuticals Ltd, Sonepat, Haryana, manufactures and exports them, and the WHO has warned that they may be contaminated with Diethylene glycol or Ethylene glycol.
The CDSCO immediately raised the issue with the Haryana State Regulatory Authority, under whose jurisdiction the drug manufacturing unit is located, and a thorough investigation was launched in collaboration with the State Drugs Controller, Haryana.
The WHO has also stated that, based on the preliminary results received, four of the 23 samples of the products under reference tested by the WHO were found to contain Diethylene Glycol/ Ethylene Glycol.
“The CDSCO had asked WHO to provide relevant analysis / reports indicating / establishing a one-to-one causal relationship between the alleged adulteration of the drugs mentioned above. WHO has yet to provide this information “According to a source.
Following further follow-up by CDSCO with the WHO, the WHO shared the Certificate of Analysis (COAS) of the sampled products, as well as a summary of the adverse events, on 11 October 2022.
The WHO has also stated that they are in the process of carrying out the investigation, according to the memorandum.
“It has been decided to form a committee comprised of technical experts to examine and analyze the details of the reports/adverse events/CoAs received to be received from WHO in the instant matter,” a person familiar with the matter told PTI.
