New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has started risk-based inspections of pharmaceutical manufacturing units in six states after 11 children died in Madhya Pradesh and Rajasthan, supposedly because of cough syrups that were tainted.
The Health Ministry says that inspections started on Friday in Himachal Pradesh, Uttarakhand, Gujarat, Tamil Nadu, Madhya Pradesh, and Maharashtra. They took 19 medicine samples, including cough syrups, antibiotics, and antipyretics, to test them. The main purpose is to find quality control problems and suggest ways to fix them so that these kinds of disasters don’t happen again.
A group of experts from the National Institute of Virology (NIV), the Indian Council of Medical Research (ICMR), the National Environmental Engineering Research Institute (NEERI), AIIMS-Nagpur, and the CDSCO is also looking at samples to find out what caused the deaths of children in Chhindwara, Madhya Pradesh.
First Results Raise Concerns
Early lab testing showed that six samples tested by CDSCO and three by Madhya Pradesh’s Food and Drugs Administration (FDA) did not have Diethylene Glycol (DEG) or Ethylene Glycol (EG), which are very dangerous substances that have caused kidney damage and deaths in other parts of the world.
However, officials from the health ministry made it clear that they were not the main syrups being looked into, like Coldrif, which is still a main suspect. Instead, the samples that were analyzed contained additional medicines that sick children used, such as antibiotics, antipyretics, and Ondansetron.
Coldrif Syrup is being looked into
The major focus is still on Coldrif cough syrup, which is made by Sresan Pharma in Kanchipuram, Tamil Nadu. The Tamil Nadu Food Safety and Drug Administration evaluated Coldrif samples taken from the company’s plant at the request of the Madhya Pradesh government.
The results, which were shared late Friday, showed that the syrup had dangerously high amounts of DEG. After this news came out:
The Tamil Nadu government banned Coldrif and told stores to take it off their shelves right away.
The Madhya Pradesh government also banned Coldrif across the state and asked drug authorities in Himachal Pradesh to test another syrup that looked suspicious.
There were inspections at Sresan Pharma’s Kanchipuram site, where samples were taken and production was stopped.
Mohan Yadav, the Chief Minister of Madhya Pradesh, said he was sad and said:
“The deaths of youngsters in Chhindwara from Coldrif syrup are very sad. Madhya Pradesh has banned the selling of this syrup. The company that makes the syrup is also being banned from making other items. There will be strict action, and those who are culpable will not be spared.
Nine children in Madhya Pradesh have died since September 7 from what is thought to be renal failure. Thirteen other children are still getting care, including eight from Chhindwara and Nagpur.
Wider State Actions and Suspensions
Kerala: Stopped selling Coldrif syrup as a safety measure. Health Minister Veena George said that the reported batch was not sent out to the state, but inspections and sample collections are still going on.
In Tamil Nadu, examinations showed that another pharmaceutical company in Chennai, besides Coldrif, made fake syrups. Officials have asked for explanations and put a stop to its operations.
Rajasthan: Rajaram Sharma, the drug controller, was fired for allegedly changing drug standards. The state also stopped the distribution of all 19 pharmaceuticals made by Kaysons Pharma, which is situated in Jaipur. This was because the company’s products had failed quality checks before. All cough syrups that had Dextromethorphan in them have likewise been taken off the market.
Uttarakhand: Joint teams are raiding pharmacies, wholesalers, and hospital pharmacies in all districts to make sure they are following safety rules.
Rajasthan Medical Services Corporation Ltd (RMSCL) said that more than 10,000 samples of Kaysons Pharma’s medications have been evaluated since 2012, and 42 of them did not pass quality checks.
Central Advice to States
The Union Health Ministry sent tough rules to all states in response to the crisis:
Children under the age of two should not be given cough and cold syrups.
Most of the time, these medicines shouldn’t be given to kids under five.
If they are prescribed, they should only be used after a full medical examination, under close medical supervision, in little amounts, and for the shortest amount of time that works.
You should stay away from using more than one medicine at a time.
The government has also said that all drugs that could be hazardous to children and pregnant women must have warning labels on them.