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Mumbai: 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, as part of a crackdown following a series of child deaths linked to adulterated cough syrups.Applicants "submitting misleading, or fake, or fabricated documents/information" will be given an opportunity to present their case in writing within 30 days of show-cause notice sent to them, the government said in a recent notification. If the person is "found to be guilty," the licensing authority shall debar them "for such period as deemed fit," it said. "It has been noticed that many firms are making unapproved claims, taking approvals from the state licensing authority," a senior government official said. "In case they are caught using forged data, action will now be taken against such companies."At present, there is no provision under the Drugs Rules, 1945 to address the issue of providing wrong information for obtaining regulatory approvals.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.Live Events"The new provision will make the process easier and faster for the drug regulator," the person added.The new provision has been incorporated under the Drugs Rules.Aggrieved applicants can challenge the licensing authority's order before the government within 30 days from the receipt of the order and the latter can pass its order "after such enquiry as it considers necessary," the notification said.The matter was discussed in the government's top drug advisory body, Drugs Technical Advisory Board (DTAB), last year."The board was apprised that at present there is no provision under the Drugs Rules, 1945 to address this issue of submitting forged/fabricated, misleading data/document, etc for obtaining the regulatory approvals. Accordingly, it was 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," according to the DTAB minutes.ET has seen the minutes of the meeting. Before the amendment, under the Drug Rule, 1945, suspension and cancellation of registration certificate or licence took place if the manufacturer failed to comply with any of the conditions of the registration certificate/licence.Add as a Reliable and Trusted News Source Add Now! (You can now subscribe to our Economic Times WhatsApp channel) Read More News ondrug manufacturersregulatory approvalsmisleading informationchild deathscough syrupsDrugs Technical Advisory BoardDrugs Rules 1945 (Catch all the Business News, Breaking News and Latest News Updates on The Economic Times.) Subscribe to The Economic Times Prime and read the ET ePaper online....moreless (You can now subscribe to our Economic Times WhatsApp channel)Read More News ondrug manufacturersregulatory approvalsmisleading informationchild deathscough syrupsDrugs Technical Advisory BoardDrugs Rules 1945(Catch all the Business News, Breaking News and Latest News Updates on The Economic Times.) Subscribe to The Economic Times Prime and read the ET ePaper online....moreless
