Substandard drugs

Seven pharma firms told to stop manufacturing

Seven erring pharmaceutical units of Solan have been told to stop the manufacturing of drugs as they failed to comply with the Schedule M norms, pertaining to good manufacturing practices (GMP).

Seven pharma firms told to stop manufacturing

Ambika Sharma

Tribune News Service

Solan,December 5

Seven erring pharmaceutical units of Solan have been told to stop the manufacturing of drugs as they failed to comply with the Schedule M norms, pertaining to good manufacturing practices (GMP).

The issue is linked to those firms whose samples were repeatedly declared substandard by the Central Drug Standards Control Organisations of various zones and the firms have been figuring in the monthly drug alert issued by the Drug Controller General of India.

Confirming the news, Navneet Marwaha, Drug Controller, said a 15-day survey of 30 drug manufacturing firms in Solan was conducted by drug inspectors and laxity was found on the premises of 12 firms where several parameters of the GMP were not being followed. He said show-cause notices were issued to the firms to ensure the compliance of the norms within a stipulated period, failing which seven units had been directed to stop manufacturing of drugs while five others brought mandatory changes, thereby allowed to continue manufacturing.

The remaining 18 firms followed the norms. Of the seven firms, five belong to the Baddi-Barotiwala-Nalagarh area while two are operating in Solan. A similar survey in Paonta Sahib was underway and the results were being compiled, Marwaha said.

Since a majority of drug samples were declared substandard in the monthly drug alerts due to the problem of dissolution and the lack of clarity of solution, the issue of less assay content, which was a cause for concern, was ruled out.

Though it is mandatory to withdraw batches of the drugs declared substandard in the monthly drug alert, several such firms were repeatedly figuring in the list, which prompted the authorities to survey the firms to assess their manufacturing facilities.

Marwaha said no laxity in the manufacturing of drugs would be tolerated. Notably, in the latest drug alert issued by the DCGI, nine medicines were declared substandard. The drugs that were declared substandard included cefpodoxime tablets IP, fruron tablets and zepara-XT tablets, which are manufactured by Zee Laboratories, Paonta Sahib.

Other firms Venus Biosciences Private Limited, Baddi, Everest Formulations, Solan, Arion Healthcare Baddi, Venus Remedies Limited, Jharmajri, Affy Pharma, Baddi, Lifecare Neuro Products Ltd, Baddi, also figured in this list.

 

Box:

The violators

The drug firms that figured in the monthly drug alert are Zee Laboratories, Venus Biosciences Private Limited, Baddi, Everest Formulations, Solan, Arion Healthcare Baddi, Venus Remedies Limited, Jharmajri, Affy Pharma, Baddi, Lifecare Neuro Products Ltd, Baddi

 

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