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DRUG LAUNCH PROCEDURES
New rules simplify drug launches, reduce manufacturer liability for overchargingNew rules now allow drug manufacturers to launch similar medicines without prior price approval, streamlining market entry. Companies can s...
Why CDSCO and BEE have not kept pace with the industries they overseeCDSCO still faces challenges like chronic understaffing, gaps in technical skills, weak lab infra and fragmented approvals. About a decade ...
The hidden cost of looking better: What health insurance covers, and what it leaves you to payRising demand for weight-loss drugs, cosmetic procedures and wellness treatments is creating a growing out-of-pocket healthcare expense cat...
Neeraj Sharma case: How fake job offers triggered major H-1B visa fraud probe in the USUS H1-B visa fraud: A major US immigration fraud probe targets 17 naturalised citizens. Neeraj Sharma, an Indian-origin CEO, faces denatura...
Properties worth Rs 2 crore attached in J&K anti-drug crackdownAuthorities have attached properties valued at approximately Rs 2 crore in Jammu and Kashmir. These assets are believed to be linked to ill...
No cosmetic job with jabs, warns drug regulator CDSCOThe notice issued by the Central Drugs Standard Control Organisation (CDSCO) cites provisions of the Drugs and Cosmetics Act, 1940, and the...
Tooth regeneration therapy enters first human clinical trials in JapanA groundbreaking human trial in Japan is exploring a revolutionary treatment to regrow teeth. Researchers have identified a way to activate...
"Zero tolerance against Narco syndicate": Amit Shah hails deportation of Dawood associate Salim DolaIndian authorities have secured the return of notorious drug trafficker Mohammad Salim Dola from Turkiye. Dola, a key figure in Dawood Ibra...
Natco Plea: Delhi high court sets aside Novartis patentNatco filed writ petition citing procedural irregularities and violation of principles of natural justice by the Assistant Controller of Pa...
FDA issues Warning Letter to Mylan Laboratories Limited's Telangana plantThe US drug regulator in a letter on September 1 told the drug-maker that the FDA investigators found lapses in the plant as there were no ...
Don’t foresee any disruptions due to Covid-19: Vasant Narasimhan, CEO, NovartisNovartis is one of the oldest pharma MNCs known for anti-cancer and anti-diabetic drugs. Despite the patent expiry for its popular anti-dia...
Violation of drug price control order: Drug cos under NPPA lens for self-exemption from price capPricing watchdog has found that companies such as Lupin and Boehringer Ingelheim launched products bypassing the regulatory framework. The ...
Biocon's pain could continue post EU drug application withdrawalBiocon shares tanked 5.9 per cent to Rs 328.80 at the close on the BSE on Wednesday.
Gennova moves application to dismiss Boehringer’s case on stroke medicineGennova alleges that Boehringer did not disclose a PIL still pending with another bench at the court on the same objections when it filed i...
Capping stent prices will halt new launches, says industryThe process may require the drug pricing watchdog to look at a set of separate parameters for these devices as compared to that for drugs.
Haryana FDA to launch online system for giving licensesHaryana FDA will soon launch an online system for giving licenses to chemist shops, medicine factories, renewal of license, and other certi...
Pharma MNCs use RTI law to protect market for patented drugs & delay entry of genericsMNCs are using such information to sue generic firms even at a stage when their marketing approval is still pending or during the few month...
- Ranbaxy misses deadline for migraine drug launch
India's largest drugmaker, Ranbaxy Laboratories, has missed its December 2008 deadline to launch an anti-migraine drug as the US regulator ...
- MNC pharma firms told to launch latest drugs in India
The government has asked MNC pharma companies to launch latest drugs in India.
- Price cut talks with pharma MNCs on hold
Reduction in prices of costly imported drugs and medical devices such as stents would remain a pipe dream for some more time.