FDA Karnataka gets Rs. 4 crore from Govt funds for sterile modular cleanroom

It also includes powders for injection or infusion, gels for injection and implants.

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FDA State Food and Drugs Administration
FDA

Last Updated on October 15, 2024 by The Health Master

In an effort to accelerate drug testing, the Karnataka drug control department has received a fund allocation of Rs. 4 crore from the Center and State to strengthen the analysis of sterile injectables.

We are setting up an advanced sterile modular cleanroom at our Bengaluru drug test lab. This is an additional facility dedicated to parenteral preparations. Although we have an existing facility analyzing the sterile injectables, going by the volume of testing, an additional facility was needed.

The central and the state governments, in a ratio of 60:40, disbursed the Rs. 4 crore, said Karnataka drugs controller B T Khanapure.

The gamut of parenteral preparations covers solutions, suspensions, and emulsions for injection or infusion. It also includes powders for injection or infusion, gels for injection, and implants.

The additional facility will give a boost to our drug testing infrastructure. In fact, all samples picked up by our enforcement team are tested here to ascertain the quality and standard of their contents.

Karnataka is also home to leading parenteral manufacturers with a significant presence in the stringently regulated global markets. Hence, an advanced sterile modular room will help us to speed up the testing, he added.

In the wake of the ongoing C-19 pandemic, Khanapure also indicated the criticality of high quality drugs and the need for reliable testing. The department’s War Room, set up during the first and second phases of the pandemic last year, exists to monitor oxygen supplies across the 30 districts.

Khanapure also said that following the state government order on the unregulated sale and use of home-testing kits, the department has now increased its surveillance on all pharmacies in the state if check if they maintain a record of the people purchasing the home test kits.

Failure to maintain details like name, address, and cell number of the purchaser needs to be maintained by all pharmacies, failing which action will be taken. The drug control team will collect the details of the home kit sales from the pharmacy outlets every day by 6 pm.

After the use of the home test kits, people will also have to inform the Bengaluru Bruhut Mahanagara Palike or any government hospital, if they find C positive.

The state drug control department has also increased its efforts to strengthen its Price Monitoring and Resource Unit (PMRU) and the hiring of the team is on.

The interviews are being conducted by the state health and family welfare principal secretary Anil Kumar TK.  Seven candidates have been called and the process is on to recruit the required team.

These are two project coordinators, three field investigators who need to be registered pharmacists and one office assistant with adequate computer skills.

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