Govt bars firms filing fake drug data from seeking fresh approvals. (Photo: IANS) NEW DELHI: In a major crackdown on regulatory fraud in the pharmaceutical sector, the Centre has amended the Drugs Rules, 1945 to empower drug regulators to temporarily debar companies that submit fake or fabricated data while seeking approvals for drugs and related licences.Under the amended rules notified by the Union health ministry on Thursday, applicants found submitting fabricated data will not only face rejection of their applications or cancellation of existing licences, but can also be barred from filing fresh applications before the concerned licensing authority, whether at the Centre or in the states, for a specified period. The action will be taken only after issuing a show-cause notice, and affected applicants will have the right to appeal.The new provision will apply to all applications filed under the Drugs Rules, 1945, and is aimed at deterring companies from submitting false scientific data to secure regulatory approvals.The ministry said regulatory decisions on the quality, safety and efficacy of medicines are based on scientific data submitted by applicants. Fabricated data undermines the integrity of the approval process, raises questions about the quality of medicines and can pose serious risks to public health. Join conversationView All Comments →Share your thoughts in the commentsInsightfulAgreeDisagreeSkepticalConcerningPromisingWorth ReadingBig DevelopmentPost CommentBe respectful · TOI community guidelinesThe amendment is intended to strengthen accountability and ensure that drug approvals are backed by reliable scientific evidence.Officials said the amendment is part of the government’s broader effort to align India’s drug regulatory framework with global best practices by promoting ethical compliance while taking stricter action against companies that indulge in malpractice.Get the latest India News and Live updates. Download the TOI app.About the AuthorAnuja JaiswalAnuja Jaiswal is a Senior Assistant Editor at The Times of India, with an impressive 18-year career in narrative journalism. She specializes in health and heritage reporting, expertly simplifying complex health information to make it engaging and understandable for readers. Her deep dives into heritage topics are well-researched, resulting in captivating narratives that resonate with her audience. Over the years, she has worked in Chandigarh, Chhattisgarh and West UP, gaining diverse on-ground experience that shapes her storytelling.Read MoreEnd of ArticleFollow Us On Social MediaVideosCentre Opposes Creamy Layer For SC-ST Quota, Says Discrimination Goes Beyond Economic StatusIAF’s : Bhawana Kanth Earns ‘Top Gun’ Title, Shivani Sehrawat Becomes Army Chief’s ADC’Cancel Exams, Take Action’: Jharkhand LoP Babulal Marandi Slams Soren Govt, Backs Student ProtestsContent Creator Ayush Rana On Jharkhand Protest Funding, Viral Videos, Dhoni’s Silence & More‘Gen Z Protesters Are Not Anti-National’: RSS’ Mohan Bhagwat Says ‘Protest Is A Way Of Dialogue’Jharkhand’s ‘Sonam Wangchuk 2.0′ Devendra Nath Mahato Enters Day 5 Of Indefinite Hunger Strike Fast’Not Enemies’: Rijiju Meets Rahul Gandhi Over Sansad Logjam, Reacts To Amit Shah Statement DemandAtiq Ahmed’s Youngest Son Abaan Dies In Jhansi Road Accident, Conflicting Accounts Emerge Over Crash‘Youth Wants CJP To Become Political Party’: Dipke, Saurav Das Announce ‘Kya Bolti Public’ CampaignBombay HC Convicts Tehelka Founder Tarun Tejpal In 2013 Sexual Assault Case; Reverses 2021 Acquittal123PhotostoriesHow to store fresh pudina without a refrigerator: 7 easy and practical hacks that actually workWhy cloves work so well in the kitchen: 6 smart hacks you didn’t knowWhy pink eye cases spike every monsoon: Eye doctor explains how humid weather helps infections spread and the mistakes that can put your vision at riskThe person most likely to motivate you, according to your birth date12 iconic sandwiches everyone should try at least onceWearing flat, cushion-less slippers at home all day? Doctor says this everyday habit could trigger months of heel pain5 things couples naturally stop doing when they feel completely comfortable with each otherKahaani Ghar Ghar Kii actress Tina Parekh ditched designer lehenga and lavish venue; opted for a simple wedding surrounded by family in an ashram8 traditional varieties of South Indian idlis that are perfect for breakfastRakul Preet Singh and Jackky Bhagnani look straight out of modern-day ‘Ramayan’ in regal Gopi Vaid ensembles123Hot PicksThailand School ShootingUPI TransactionsAsk Me AnythingJharkhand protestGurgaon rainNICL Assistant RecruitmentAnkur WarikooIndia Labour CodesGold rate todayTop TrendingCockroach Janta PartyNagpur Rape CaseAbhijeet DipkeGujarat Mystery WellJPSC ProtestNagpur Rape CaseDelhi Wife MurderAkhilesh YadavTamil Nadu BudgetPraveen Nettaru Murder Case
NEW DELHI: In a major crackdown on regulatory fraud in the pharmaceutical sector, the Centre has amended the Drugs Rules, 1945 to empower drug regulators to temporarily debar companies that submit fake or fabricated data while seeking approvals for drugs and related licences.Under the amended rules notified by the Union health ministry on Thursday, applicants found submitting fabricated data will not only face rejection of their applications or cancellation of existing licences, but can also be barred from filing fresh applications before the concerned licensing authority, whether at the Centre or in the states, for a specified period. The action will be taken only after issuing a show-cause notice, and affected applicants will have the right to appeal.The new provision will apply to all applications filed under the Drugs Rules, 1945, and is aimed at deterring companies from submitting false scientific data to secure regulatory approvals.The ministry said regulatory decisions on the quality, safety and efficacy of medicines are based on scientific data submitted by applicants. Fabricated data undermines the integrity of the approval process, raises questions about the quality of medicines and can pose serious risks to public health.
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The amendment is intended to strengthen accountability and ensure that drug approvals are backed by reliable scientific evidence.Officials said the amendment is part of the government’s broader effort to align India’s drug regulatory framework with global best practices by promoting ethical compliance while taking stricter action against companies that indulge in malpractice.
