Centre, states crack down on contaminated drugs after deaths from toxic cough syrup
After 11 children died in MP and Rajasthan, Centre and states act against toxic cough syrups; Tamil Nadu bans Coldrif, CDSCO inspects drug units
The Centre and state governments of Tamil Nadu, Rajasthan and Madhya Pradesh have started a crackdown on contaminated drugs, including cough syrups and antibiotics, following the deaths of 11 children in Madhya Pradesh and Rajasthan due to the consumption of contaminated cough syrup.
While the Union Health Ministry on Saturday (October 4) said that the central drug regulator, CDSCO, has initiated risk-based inspection at the manufacturing units of 19 drugs across six states, the Tamil Nadu government has banned the sale of Coldrif Cough Syrup after samples of the drug collected from the manufacturing unit of Sresan Pharma in Kanchipuram were found to be contaminated.
Also Read: Tamil Nadu bans 'Coldrif' cough syrup after 11 child deaths in MP, Rajasthan
Test conducted after MP govt’s request
The test was conducted by the Tamil Nadu government at the request of the government of Madhya Pradesh.
"The results were shared with us late Friday evening... The samples had DEG beyond the permissible limit," the ministry said.
Following this, the Tamil Nadu government banned the sale of the cough syrup and ordered its removal from the market.
The Rajasthan government has also suspended the state drug controller and halted the distribution of medicines manufactured by Jaipur-based Company Kaysons Pharma.
Also Read: 7 children die of kidney failure allegedly caused by contaminated cough syrup
Centre swings into action
The inspections by the Central Drugs Standard Control Organisation (CDSCO) began on October 3 with the aim to identify gaps that may have led to drug quality failures and also suggest process improvement to avoid such incidents in future, it said.
Additionally, a multidisciplinary team comprising experts from the National Institute of Virology, the Indian Council of Medical Research, National Environmental Engineering Research Institute, CDSCO and AIIMS-Nagpur, among others, are still analysing the various samples and factors to assess the cause of deaths in and around Chhindwara in Madhya Pradesh, it stated.
The Union Health Ministry on Friday said six drug samples tested by CDSCO and three by the Madhya Pradesh Food and Drugs Administration (MPFDA) were found to be free of Diethylene Glycol (DEG) and Ethylene Glycol (EG) contaminants that are known to cause serious kidney injury.
Also Read: India bans anti-cold drug combination after 141 deaths in Africa, Asia
Rajasthan suspends drug controller
As for the suspension of the drug controller Rajaram Sharma, the state Health Department said that the decision was taken after he allegedly tried to influence the process of determining drug standards.
Chief Minister Bhajanlal Sharma has ordered a detailed probe into the matter along with effective action.
Following his instructions, an expert committee is being constituted to investigate the issue.
Health Minister Gajendra Singh also ordered an inquiry and measures to safeguard public interest, an official statement said.
Also Read: Contaminants found in syrup samples of 2 pharma cos in TN, Gujarat
Centre’s advisory
Principal Secretary in the Medical and Health Department, Gayatri Rathore, said the Union government issued an advisory in 2021 against administering Dextromethorphan to children below four years.
The state has reiterated the advisory, while the Drug Controller General of India on Friday advised that the syrup should normally be given only to children above five years, and in no circumstances to those under two years of age.
Officials added that drugs which are potentially harmful to children and pregnant women will now carry clear warning labels.
Also Read: Should homeopathy, ayurveda specialists be called ‘doctors’? The great medical divide
42 samples of Kaysons Pharma drugs failed test
According to the managing director of Rajasthan Medical Services Corporation Ltd (RMSCL), Pukhraj Sen, over 10,000 samples of Kaysons Pharma drugs have been tested since 2012, of which 42 failed the quality standards.
As a precaution, the supply of all 19 medicines manufactured by the company has been suspended.
Meanwhile, Congress leader Kamal Nath on Friday blamed the mixing of 'brake oil solvent' in cough syrups for the deaths of children with a suspected kidney ailment in Madhya Pradesh's Chhindwara district since September 7.
(With agency inputs)