CDSCO Starts Risk-Based Inspection At Manufacturing Units In Six States

CDSCO Starts Risk-Based Inspection At Manufacturing Units In Six States


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.



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