At least six children succumbed to death in Chhindwara city of Madhya Pradesh owing to kidney failure and the district authorities suspect a link to the role of allegedly contaminated cough syrup in the tragedy.
The authorities allege that the cough syrups with presence of unacceptable levels of diethylene glycol (DEG) has caused the deaths and the district collector has imposed a ban on sale of at least two brands of cough syrups, according to news reports.
The cases were reported in the last few weeks, at least from the last week of August, with the first death linked to the issue reported on September 7. An agency report on October 1 said that the death toll has gone up to seven.
The children showed symptoms such as high fever and difficulty in urinating, which are the signs of kidney failure. Reports quoting doctors from the Chhindwara Medical College said that the biopsy results showed contamination by DEG in in the cough syrups.
The regional authorities also said that experts from Indian Council of Medical Research (ICMR) has visited the region recently and collected samples for tests.
Sources from the Union ministry of health said that a National Centre for Disease Control (NCDC) team visited the area to collect samples and the reports of the tests are still awaited. The state drug authority is conducting tests on the drug samples.
The NCDC's test results are expected to be shared with the State authorities for further analysis and action.
The mishap, if proven to be a result of substandard cough syrup, will be a fresh fiasco to the drug regulatory mechanism in the country, which took several measures a couple of years ago to restrain such events raising out of unacceptable levels of DEG present in cough syrups.
In the year 2022, the World Health Organisation (WHO) issued a medical product alert alleging that the substandard paediatric cough syrups from an Indian manufacturer has resulted in death of 66 children in Gambia, and the following action from the countries including Gambia has brought bad reputation to the Indian pharma industry.
The WHO, later also alleged that the cough syrup imported from India has resulted in the death of children in Uzbekistan.
The pharma export promotion council during the time said that this was also likely to have an impact on the trust of international agencies on India pharmaceutical exports.
This triggered a set of quality ensuring measures from the Union health ministry and the Drugs Controller General of India (DCGI), including stringent test on the cough syrup batches for exports and daily updation of number of tests by each laboratory.
In an effort to reclaim the trust on quality of medicines manufactured in India, the central drug regulator initiated joint risk based inspections in collaboration with the state drug regulatory authorities throughout the country, issued show cause notices and suspension of manufacturing license in case of deviation from the manufacturing standards.
Following the fiasco, which raised concerns on the overall quality of drugs produced in the country, the drug regulator also revised the Schedule M manufacturing standards with deadlines for the large, medium and small manufacturers to comply with them. This has raised concerns from the small and medium drug manufacturers in the country, and many units are on the verge of closure, once the deadline is over. |