India-made cough syrups are under the scanner after the death of 66 children in The Gambia, a nation in West Africa. Following an alert from the World Health Organization (WHO), the Indian government has started an investigation into the four fever, cold and cough syrups manufactured by a Haryana-based pharmaceutical firm.
The WHO has urged people not to use the four syrups — Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup – made by Maiden Pharmaceuticals. All batches of the products “should be considered unsafe” till they are analysed by the respective national regulatory authorities, it said.
WHO Director-General Tedros Adhanom Ghebreyesus on Wednesday told reporters the UN agency was investigating the deaths from acute kidney injuries with India’s drug regulator and Maiden Pharmaceuticals.
After the WHO alerted the Drugs Controller General of India (DCGI) on 29 September, the Central Drugs Standard Control Organisation (CDSCO), the national regulatory body for cosmetics, pharmaceuticals and medical devices, took up the matter with the Haryana regulatory authority and launched a detailed investigation, sources told NDTV.
The four substandard medicines identified by the WHO are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup. Image courtesy: WHO
While the exported cough syrups have raised concern, India has a problem of its own. Spurious, adulterated and substandard medicines continue to be sold in Indian markets.
What are spurious and adulterated drugs?
The Drugs and Cosmetics Act, 1940 defines a drug as spurious if it is manufactured under a name which belongs to another drug or if it is in imitation of or substitute of another drug and purports the purpose of a manufacturer of whom it is truly a product.
A drug is deemed adulterated if it consists in whole or part any filthy, putrid or decomposed substance; if it is prepared, packed or stored under insanitary conditions; if it contains any harmful or toxic substance which may render it injurious to health; or if any substance has been mixed therewith so as to reduce its quality or strength, according to the Act.
Also read: Explained: Why the Centre is planning to ban some Codeine-based syrups
Substandard drugs work less effectively, causing the disease to run a longer course, and can even require a new prescription during treatment. They also contribute to antibacterial resistance, a threat that doubled in India between 2011 and 2016, according to an IndiaSpend report.
The Drugs and Cosmetics Act 1940, treats the sale of substandard drugs as a serious offence. The law calls for a jail sentence of a minimum of one year and fines for the manufacturer; for the entire batch of the drug to be recalled from the market; and for the manufacturer to conduct a root-cause analysis into how the faulty drug got made.
India is one of the largest exporters of generic medicines in the world. Reprsentational image/Pixabay
How bad is India’s substandard and counterfeit drug problem?
According to a 2017 WHO report, about 10.5 per cent of medicines sold in low and middle-income countries, including India, are substandard and falsified. A report by United States Trade Representative (USTR) said that 20 per cent of all pharmaceutical products sold in the Indian market are counterfeit.
In 2018, the national drugs regulatory body identified about 4.5 per cent of all generic drugs in the Indian market to be substandard.
In February 2020, several batches of generic medicines being sold at Jan Aushadi Kendras, some 632 in Karnataka, and more pan-India were recalled after failing standard quality tests of state drug controller. In 2019-2020, India recalled four drugs and 27 batches.
The Union government informed Parliament in July this year that various state and union territories’ drug controllers tested over 84,874 drug samples in 2021, out of which 2,652 drug samples were declared not of standard quality while 263 samples were declared spurious or adulterated, reports moneycontrol.
According to a report by Authentication Solutions Providers’ Association (ASPA), a non-profit organisation dealing in the area of anti-counterfeit awareness, the incidents of sub-standard and falsified (SF) drugs and other medical products related to COVID-19 increased by almost 47 per cent just within a year – from 2020 to 2021.
The biggest concern, of course, remains adulterated drugs. In 2020, about 13 children, all under five years of age, died after drinking adulterated cough syrup. Earlier that year, around a dozen children from a village in Jammu, succumbed after drinking another diethylene-glycol-laden tonic, called Coldbest, reports Mint.
However, this is not a new problem. In 1986, 14 patients died after treatment with diethylene-glycol-tainted glycerine in Mumbai’s Jamshetjee Jejeebhoy Hospital.
In 2018, about 4.5 per cent of all generic drugs in the Indian market were found to be substandard. Representational image/Pixabay
How is our reputation in the world?
India is one of the largest exporters of generic medicines. Forty per cent of over-the-counter and prescription generics sold in the US come from India. In the UK, a quarter of all generics come from India, and generics account for 80 per cent of National Health Service prescriptions, reports CNN.
A special “301 Report” by United States Trade Representative published in 2019 said that India was a leading source of counterfeit medicine distributed locally. The report claimed that India exports counterfeit drugs to Africa, Canada, the Caribbean, the European Union, South America and the United States.
However, India has rejected the allegations, saying it was an attack on low-cost generic drugs which are crucial to making healthcare affordable.
Where does India go wrong?
Under the National Good Laboratory Practice programme, India has only 47 drug testing facilities and six central labs, testing just 8,000 samples per year. Moreover, the country has only 20-30 test laboratories that can affirm whether a drug is counterfeited, authentic or of relatively poor make, according to a report in The Financial Express.
Experts say that there need to be more stringent guidelines to stop such malpractices. Mahesh Zagade, who headed the Maharashtra Food and Drugs Administration between 2011 and 2014, told Mint that the Drug Consultative Committee’s guidelines “are designed to protect the industry, not to safeguard the patient”.
What efforts is India taking to tackle the problem?
On 29 August, Union Minister of Chemical and Fertilisers Mansukh Mandaviya said that the pharmaceutical industry needs to act against firms involved in manufacturing substandard and falsified medical products in the country.
“It feels absurd when fake and spurious drugs are detected by the drug controllers in the country; the pharma industry needs to act on these incidents. If there is bargaining at quality of medicines by any company, then firms involved in malpractices should be ousted from the associations,” he warned.
With inputs from agencies
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