DCGI lines up GuruFcure for making up data to obtain manufacturing approvals
Indian drug regulator, DCGI, has spotted, GuruFcure a contract drug manufacturing company for fabricating data when seeking nod for manufacturing combination drugs. The company is suspected to have submitted made up and fabricated data when obtaining manufacturing approvals of seven fixed dose combination (FDC) drugs.According to the regulatory team that was involved in the investigations, it was revealed that the fictitious data was submitted by the contract manufacturer of the seven FDC drugs. All the data that was submitted was fabricated and no authenticity could be established. DCGI had communicated to the company through a letter and rejected its application.
The contract manufacturer seems to be claiming about having tie-ups with major pharmaceutical companies and considers itself as a one of the leading manufacturer of drug formulations. Earlier, during this year, the company had approached the drug regulator for seeking approval to manufacture certain antibiotics combinations. The data was found to be false and the regulator had asked for clarification.