The government will bar drugmakers from selling their products if they are found to have provided false information to obtain regulatory approvals or mislabelled their brands.The Union Ministry of Health & Family Welfare on Thursday notified amendments to the Drugs Rules, 1945, adding a significant new layer of accountability to the country’s pharmaceutical regulatory framework.Read more: Centre deploys national outbreak team to Gujarat, Rajasthan as Chandipura virus cases riseUnder the new provisions, the Licensing Authority at the state or central level can now debar an entity from filing further applications for a specified period.The rule applies across all applications filed under the Drugs Rules, 1945, covering the full range of licences and permissions that drug manufacturers and distributors require to operate.An appeal mechanism has also been provided.A show-cause notice will be issued before any such action is taken, ensuring due process.Until now, the drug regulator has been taking action against such firms by filing FIRs under the provisions mentioned in the Indian Penal Code, which is tedious and time consuming, the official said.“The new provision will make the process easier and faster for the drug regulator,” an official said.According to the ministry, the amendment is intended to deter misconduct, strengthen accountability, and ensure that drug approvals are backed by reliable and scientifically valid evidence.The matter was discussed in the government's top drug advisory body, Drugs Technical Advisory Board (DTAB), in 2024. Last year the DTAB proposed that provisions may be incorporated under the Drugs Rules, 1945, for taking action against applicants for submitting misleading, or fake or fabricated documents/data to the licensing authority, ET had reported.