Special Public Prosecutor Atul Sarpande had opposed their bail saying Rhea and Showik financed and arranged drugs.
'We are also seeing the birth of new evil, the new face of drug distribution where human interface has reduced; consumers are using the Dark Web to source supplies and using cryptocurrencies as payment mode.'
USFDA issues Form 483 with as many as 14 observations that could impact ongoing operations at Aurobindo's Pashamailaram facility in Hyderabad.
The Union health ministry on Thursday termed as 'misleading' and 'fallacious' media reports which claimed that regulatory approval for COVID-19 vaccine Covaxin was rushed due to political pressure.
The court rejected Chakraborty's bail application. The NCB told the court that she was an 'active member' of a drugs syndicate and procured drugs for Rajput, her boyfriend.
Bharat Biotech is targeting to manufacture one billion doses of its intra-nasal vaccine in 2022 which is under clinical trials now.
Indian drug firms like Marksans Pharma, Aurobindo Pharma, Zydus and Jubilant are recalling products in the US market, as per the latest enforcement report by the US Food and Drug Administration (USFDA). While Marksans Pharma is recalling diabetes drug, Zydus Pharmaceuticals (USA) is recalling drug which is used to reduce stomach acid. Similarly, Aurobindo Pharma (USA) is recalling pain relieving drug, while Jubilant Cadista is recalling a medication used to treat schizophrenia.
The four-five member team, led by NCB's Deputy Director General (northern region) Gyaneshwar Singh, is also likely to visit a few other places and will also record the statement of Prabhakar Sail, an independent witness in the case.
Maharashtra home minister Dilip Walse Patil on Monday said police protection has been given to Prabhakar Sail, an independent witness in the drugs-on-cruise case who has claimed Rs 25 crore was demanded by an NCB official and other persons to let off Bollywood superstar Shah Rukh Khan's son Aryan Khan in the case.
The NCB further said both Rhea Chakraborty and her brother had "abetted and financed" drug transactions.
The NCB, through a special public prosecutor, had argued that there were "compelling reasons" to seek the extension.
Officials of the NCB, which filed its chargesheet in a Mumbai court, said Aryan Khan and five others had not been named due to 'lack of sufficient evidence'.
Firms, foreign and Indian, reiterate they follow the rules fully. Earlier, SC had rapped govt for gaps in law and enforcement, including on compensation.
"It has been decided that for approval of COVID-19 vaccines in India for restricted use in emergency situation which are already approved for restricted use by US Food Drug Administration, European Medicines Agency, UK Medicines and Healthcare products Regulatory Agency, Pharmaceuticals and Medical Devices Agency Japan or which are listed in WHO Emergency Use Listing and which are well established vaccines from the stand point that millions of individuals have already been vaccinated with the said vaccines, the requirement of conducting post approval bridging clinical trials and of testing every batch of vaccine by CDL, Kasauli can be exempted, if the vaccine batch/lot has been certified and released by National Control Laboratory of country of origin," it said.
The new regime aims to bring in ease of doing business, as the NITI Aayog has proposed to do away with the need to have manufacturing licences to register medical devices or to get a certificate of compliance.
Aseem Chhabra's Top 10 Films/ Series from TIFF 2024 includes films that he watched for the first time in Toronto. The films were impressive due to their rigor, passion, unique storytelling style and sometimes exploring the vulnerable sides of big name stars.
An expert panel of India's central drug authority on Wednesday recommended granting regular market approval to COVID vaccines Covishield and Covaxin for use in adult population subject to certain conditions, official sources said.
Swine flu claimed 38 more lives in the country taking the death toll beyond 800 even as the total number of people affected by the disease on Sunday breached the 13,000 mark.
In a lengthy statement shared on Instagram, the filmmaker said neither he consumes narcotics nor does he promote usage of any such substance. Johar's response came after an old video from a star-studded party at his residence resurfaced on social media, amid Narcotics Control Bureau's (NCB) drugs probe in connection with actor Sushant Singh Rajput's death.
India's drug regulator has given permission to Bharat Biotech to conduct phase-3 clinical trial for its intranasal Covid vaccine as booster dose on participants who have been previously inoculated with SARS-CoV 2 vaccines.
Ananya's father Chunky Panday accompanied her to the NCB office located at Ballard Estate in south Mumbai, where they reached around 4 pm.
Agency sleuths claimed he was arrested after they obtained some "vital leads" into the narcotics case registered against Rajput's live-partner Rhea Chakraborty and others.
Swiss drug maker Novartis might face tough action from the country's drug regulator for allegedly giving fake documents while seeking renewal of registration for Tiamulin Hydrogen Fumerate (80 per cent granules), sources said.
The Subject Expert Committee on COVID-19 examined the data and deliberated on the EUA application on Monday.
The Pune-based firm had submitted interim safety and immunogenicity data of phase 2/3 bridging clinical trial conducted in the country as well as interim clinical trial data of safety and efficacy from phase3 clinical trials conducted in the UK and the US along with its application.
Deepika and her husband Ranveer Singh on Thursday flew back to Mumbai from Goa, ahead of her appearance before the NCB. The couple arrived at Goa International Airport amid heavy security around 8 pm and boarded a chartered flight.
Government plans to move from controlling bulk drugs to formulations.
The current crisis has forced the government to announce measures to ensure that India becomes self-sustaining for any kind of bulk drug. The government says India will not depend on any other country for vital key ingredients for drugs within six years, reports Sheela Bhatt.
Their counsel Satish Maneshinde told the HC that the drugs case, in which Rhea and Showik are accused and currently in jail, should have been transferred to the Central Bureau of Investigation (CBI), probing Rajput's death, by the NCB.
While granting him bail on December 2, special NDPS court judge G B Gurao observed that the ingredient of Section 27-A of the NDPS Act does not apply to Showik's case.
Move follows a spate of international regulatory enforcements on Indian drug firms.
Addressing a press briefing, Union Health Secretary Rajesh Bhushan said Zydus Cadila, Sputnik V, Biological E and Gennova are other vaccines also in the pipeline which are in advanced clinical trials in India.
BE's Corbevax is the first such vaccine in India to be approved as a heterologous COVID-19 booster in the country.
'An entire operation was running systematically prior to the revoking of Article 370.'
The panel headed by Justice (retired) Ritu Raj Awasthi has submitted its report to the government, calling for an exhaustive overhaul of the law.
In her bail application filed in the HC on Tuesday, Chakraborty said she is just 28 years of age, and besides the probe by the NCB, she has been subjected to three more investigations by police and central agencies, and a "simultaneous media trial".
The central drug regulator has issued show cause notices to these two importers and asked to stop the import of rapid test kits based on the observation by the apex health research body Indian Council of Medical Research (ICMR).
Traction for its specialty portfolio, a strong showing in the domestic market, and better regulatory compliance are positives for the country's largest pharmaceutical (pharma) company, Sun Pharmaceutical Industries. Given the triggers, some brokerages have increased their earnings per share estimates and target price for 2024-25 (FY25). This should sustain the momentum for the stock, which has been one of the major pharma gainers in 2023-24 (FY24), rising 57 per cent. It is currently trading at Rs 1,547 per share.
FDA had also issued warning letters to Ranbaxy's Paonta Sahib and Dewas facilities as it found extensive problems and deviations from manufacturing norms.
