The World Health Organisation (WHO) linked the death of dozens of young children in The Gambia to contaminated cough and cold syrups made by New Delhi-based Maiden Pharmaceutical Ltd. This was announced by WHO Director-General Tedros Adhanom Ghebreyesus following the analysis of several medical syrups that were suspected of causing 66 child deaths in the tiny West-Africa country, The Gambia.
This topic forms an important part of the current affairs section for the IASÂ Exam.
Indian Cough Syrups and Deaths in The Gambia
The WHO issued a medical product alert asking regulators to remove Maiden Pharma goods from the market.Â
- The alert covers four products – Promethazine oral solution, Makoff Baby cough syrup, Kofexmalin Baby cough syrup and Magrip N Cold syrup.Â
- The lab analysis confirmed unacceptable amounts of diethylene glycol and ethylene glycol which can be toxic and lead to acute kidney injury.Â
- Earlier also, the Bihar State Health Department had blacklisted Maiden Pharma in 2011 after six batches of two of its drugs were found of sub-standard quality.
Four-member panel to probe The Gambia deaths
The Centre has formed a four-member panel to examine the detailed report shared by the WHO. The panel will be headed by Dr. Y. K. Gupta, Vice Chairperson of the Standing National Committee on Medicines.
WHO Chief Scientist Dr Saumya SwaminathanÂ
The World Health Organisation’s chief scientist Dr Soumya Swaminathan said the death of children in The Gambia, potentially linked to four Indian-made cough syrups, was a serious issue. Swaminathan asserted that India needs to harmonise operations between central and state-level drug regulators. For India to remain a leader in the generic medicines and vaccines space, it is important to prove that it has a strong regulatory system. She was speaking on the sidelines of the annual general meeting of the Developing Countries Vaccine Manufacturers Network (DCVMN).
The World Health Organisation has identified 20 such deadly drugs with origins in India and Indonesia that have been linked to over 300 international deaths so far as a result of tainted cough syrups.
News in detail:
- Cough medication, paracetamol, and vitamins are all available as syrups. These would comprise the 15 tainted syrups that were previously discovered, seven of which were produced in India by the firms Maiden Pharmaceuticals in Haryana (four), Marion Biotech in Noida (two), and QP Pharmachem in Punjab (one). The rest was created in Indonesia.
- The WHO has already issued medical product alerts for 15 medications in the Marshall Islands, Micronesia, Gambia, and Uzbekistan, where syrups made in India were responsible for at least 88 fatalities in the previous year. In Indonesia, where the syrups, which were locally sold, were connected to the deaths of more than 200 children, it also generated concern.
- CDSCO is the National Regulatory Authority of India for cosmetics, pharmaceutical and medical devices. The CDSCO – Central Drugs Standard Control Organization comes under the Directorate General of Health Services, Ministry of Health and Family Welfare.
- 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 Organizations by providing expert advice with a view of bringing about uniformity in the enforcement of the Drugs and Cosmetics Act.
- The Drugs Controller General of India (DCGI) is the head of the Department of the CDSCO.
Drug Safety Norms in India for Export
The first point of testing is at the manufacturer’s level to ensure the drug adheres to the safety norms prescribed by the Indian Pharmacopoeia and the regulatory requirement of the country of export. However, in most cases, the destination countries expect nations of origin to strictly follow the norms prescribed by the pharmacopoeia under which the sale is governed.
- Some destination countries do internal testing at the point of entry, however, it is not mandatory and varies for each country.
- A manufacturer needs certification from the CDSCO, National Regulatory Authority to export drugs.
- At the time of granting a licence, a drug inspector assigned by the Indian Regulator may collect samples in any phase of manufacturing for quality checks. It, however, is not mandatory and is rarely done.
International drug safety norms:Â
- These are usually country specific.
- The US, Japanese, European, Chinese and Britain Pharmacopoeias act as reference points for uniform preparations for most of the commonly used drugs.
- The WHO’s prequalification programme is another criterion wherein the UN body certifies the sale of drugs/vaccines under the UN programmes.
The Gambia Deaths – Fallout for the Indian Pharmaceutical Industry
The quality of Indian drugs delivered to African nations like the Gambia has come under scrutiny, and as a result, India’s pharmaceutical exports to the African market fell by 5% in FY23. The cough syrups produced by an Indian pharmaceutical company are currently being investigated for the alleged deaths of 70 children in the Gambia.
- Africa contributed 18 percent of the total $19.9 billion in exports of finished pharma products, excluding active pharmaceutical ingredients (APIs), in FY23, according to the Commerce Department data.Â
- Affordable health care solutions, including necessary medications for HIV/AIDS, malaria, tuberculosis, and other prevalent illnesses, are backed by India’s cost-effective generic medications.
Pharma Exports from India
India’s pharmaceutical exports have continued to rise, hitting $25.3 billion (approximately Rs 2,08,231 crore) during the fiscal year 2022–23.
- With a 20% volume share, India is the largest generic drug provider in the world.Â
- Through a network of more than 10,500 production facilities, more than 3,000 pharmaceutical companies manufacture their goods throughout the nation.
- Government statistics show that India’s pharmaceutical exports more than doubled during the 2014-2022 period.
- Bulk drug parks and the production-linked incentive programme will further help to increase domestic manufacturing capacity.Â
Diethylene glycol/Ethylene glycol adulteration:Â
- Adulterants like diethylene glycol and ethylene glycol are occasionally used illegally as solvents in liquid medicines.Â
- Pharma businesses may substitute diethylene glycol and ethylene glycol for non-toxic solvents like glycerine or propylene glycol to reduce expenses.
- Ethylene glycol intoxication can result in central nervous system depression, nausea, vomiting, intoxication, euphoria, stupor, respiratory depression, and decreased excretion of urine.
- Serious poisoning may cause coma, loss of reflexes, seizures (rare), and irritation of the brain’s lining tissues.
Image source: The First Post
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