New Delhi | Central drug regulator CDSCO has initiated risk-based inspection of drug manufacturing units in six states following collection of 19 samples including that of cough syrups, antipyretics and antibiotics in the wake of child deaths in Madhya Pradesh and Rajasthan allegedly due to contaminated cough syrups.

The manufacturing units are in Himachal Pradesh, Uttarakhand, Gujarat, Tamil Nadu, Madhya Pradesh and Maharashtra where 19 samples of different drugs were manufactured, sources in the health ministry said.

The inspections by the Central Drugs Standard Control Organisation (CDSCO) began on Friday 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, the ministry 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.

On Friday, the ministry said that six samples that have 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.

Sources from the ministry clarified that the "samples that have been tested so far by CDSCO were not of the two suspected cough syrups one of which is Coldrif that have been under scanner since the deaths".

"The six drug samples tested by CDSCO which did not show presence of DEG/EG were of other drugs and syrups including antibiotics, antipyretics and Ondansetron, consumed by the children who fell ill in the Chhindwara district of Madhya Pradesh," a source said.

The analysis of the samples of Coldrif and the other suspected cough syrup by Madhya Pradesh state drug authorities is still underway.

At the request of the Madhya Pradesh government, the Tamil Nadu Food Safety and Drug Administration Department tested samples of Coldrif Cough Syrup collected from the manufacturing unit of Sresan Pharma in Kanchipuram, Tamil Nadu.

"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.

Inspections were also conducted at the pharmaceutical company's manufacturing facility in Sunguvarchathram in neighbouring Kancheepuram district during the last two days, and samples have been collected, he said.

Madhya Pradesh government has also written to Himachal Pradesh Drug Authority for conducting testing of the other cough syrup under scanner.

The Madhya Pradesh government also on Saturday banned the sale of Coldrif syrup.

According to officials, nine children have died due to suspected renal failure since September 7. Currently, 13 children, including eight from Chhindwara and Nagpur, are undergoing treatment.

"The deaths of children in Chhindwara due to Coldrif syrup are extremely tragic. The sale of this syrup has been banned across Madhya Pradesh. A ban is also being imposed on other products of the company that manufactures the syrup," Chief Minister Mohan Yadav stated on X.

The syrup was manufactured at a factory in Kanchipuram. Following the incident, the state government requested that the Tamil Nadu government conduct an inquiry. The investigation report was received this morning, and strict action has been taken, he stated.

A team has also been constituted at the state level to investigate the matter, Yadav said, adding that the guilty will not be spared.

Meanwhile, Kerala Drugs Control department also has suspended the sale of Coldrif cough syrup in the state following reports from other states that flagged issues with one of the batches of the Coldrif syrup, Kerala Health Minister Veena George on Saturday said.

A preliminary inquiry by the State Drugs Control Department revealed that the flagged batch of the drug was not sold in Kerala, the minister clarified in a statement.

Noting that the Drugs Control department has conducted intensive inspections in the state, George said samples of Coldrif syrup have been collected for examination.Along with this, samples of other cough syrups are also being examined.

Besides, test samples of cough syrups collected from a Chennai-based firm during an inspection conducted at its facility have been found to be 'adulterated', an official of the Food Safety and Drug Administration department said on Saturday.

The officials have sought an explanation from the Tamil Nadu-based company and has instructed it to halt production at its facility near here, the official said.

The development came after Tamil Nadu government banned the sales of cough syrup 'Coldrif' and ordered removal of stocks of the medicine from the market.

Apart from that, the Rajasthan government has suspended the state drug controller and halted the distribution of medicines manufactured by Jaipur-based company Kaysons Pharma, officials said.

The Medical and Health Department stopped the supply of all 19 medicines manufactured by Kaysons Pharma until further orders, they said.

Distribution of all other cough syrups containing Dextromethorphan has also been suspended.

The government has placed drug controller Rajaram Sharma under suspension for allegedly influencing the process of determining drug standards, the department said.

This comes amid reports of deaths of 11 children, nine in Madhya Pradesh and two in Rajasthan, allegedly linked to contaminated cough syrup.

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.

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.

In Uttarakhand, joint teams of the health department and Food Safety and Drug Administration (FDA) are conducting raids on medical stores, wholesale drug vendors and hospital pharmacies in all districts.

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.

The Centre on Friday had issued an advisory to all states saying that cough and cold medications should not be prescribed to children below two years.

The DGHS, Union Health ministry in its advisory mentioned that Cough syrups are generally not recommended for ages below 5 years and above that, any use should follow careful clinical evaluation with close supervision and strict adherence to appropriate dosing, the shortest effective duration and avoiding multiple drugs combinations.