Health ministry tightens regulations for medical devices and in vitro diagnostic manufacturers to prevent misuse

To prevent misuse of raw materials collected from blood centres, the Union health ministry has issued new norms for domestic manufacturers of kits and medical devices requiring Transfusion-Transmissible Infection (TTI) sero reactive blood bags from blood centres as a raw material for preparing in vitro diagnostic (IVD) reagents.

As part of the plan, every firm will need to submit an affidavit to the licensed blood centre with a copy to the respective State Licensing Authority and Central License Approving Authority declaring that the firm will maintain a record of the blood collected and its usage.

They will also have to maintain the record of the quantity of antigen used for the manufacture of the kits to avoid the misuse of the TTI reactive blood bag.

The ministry said that auditors from the Central Drugs Standard Control Organization (CDSCO), will check risk management protocols and records for the usage, and disposal of infectious materials at the manufacturing facility to ensure employee health safety and environmental protection.

Mandatory to maintain blood record

Making compliance stricter, the government has made it mandatory for the manufacturer to maintain a record of the blood collected and its usage.

The manufacturer also must get the approval of State Blood Transfusion Council for the collection of reactive blood bags/ samples from the blood centres of that State/Union Territory.

The ministry further said that the manufacturer needs to submit an undertaking to the blood centre concerned, stating that they would adhere to the Biomedical Waste Management Rules, 2016 laid down for handling and storage of biohazardous materials.

Furthermore, the blood centre will need to maintain a record of the number of blood bags given to the manufacturers and similar records shall be kept by the manufacturers.

Queries sent to the health ministry remained unanswered.