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No external pressure to accelerate Covaxin development: Bharat Biotech

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 Vaccine-maker Bharat Biotech has denied that there was any external pressure to accelerate development of Covaxin, its vaccine for Covid-19.

“We condemn the targeted narrative against Covaxin put forth by a select few individuals and groups who have no expertise in vaccines or vaccinology. It is well known that they helped perpetuate misinformation and fake news throughout the pandemic. They are unable to comprehend global product development and licensure processes,” the Hyderabad-based company said in a statement on Thursday.

“The pressure was all internal to develop a safe, and effective vaccine for the Covid-19 pandemic, to save lives and livelihoods in India and globally,” it added.

The company claimed that Covaxin is one of the most highly studied covid-19 vaccines worldwide.

Covaxin was evaluated in about 20 preclinical studies, including three challenge trials and nine human clinical studies, more than any other Indian Covid-19 vaccine. These trials have clearly demonstrated safety and efficacy of Covaxin, Bharat Biotech said.

The vaccine-maker further claimed that with several hundred million doses administered worldwide, Covaxin has demonstrated an excellent safety record with minimal adverse events and no vaccine associated cases detected for myocarditis or thrombocytopenia.

“The entire product development and clinical studies were executed as per global guidelines and submitted worldwide. Data from Covaxin has resulted in more than 20 publications, documenting every aspect of its development.”

It termed as “incorrect and erroneous’ the recent media reports around the approvals for Covaxin.

“These few individuals and organizations were mostly involved in fake news and false information during the pandemic. They fail to understand product development and licensure pathways worldwide,” reads the statement.

It pointed out that the phase 1 study for Covaxin was one of the largest in the world, resulting in both the 3 and 6 mcg doses demonstrating safety and comparable immunogenicity.

The decision to proceed to phase III trials was taken based on data from phase I studies and results from successful animal challenge trials.

The phase II studies were designed to determine if the lower dose of 3 mcg would be effective, instead of the 6 mcg dose, which would have doubled our manufacturing capacity. In the interest of public health, it was decided to proceed with the 6 mcg dose for phase III clinical trials.

According to Bharat Biotech, vaccines against ebola and monkey pox, were approved by stringent regulatory agencies in developed countries based on phase I and II clinical data only and without phase III data.

“If such an approval was given by regulators in India, there would be an uproar, but the same people and organisations remain silent, demonstrating their hypocrisy.

“While these people and organizations were busy with false information and fake news during the pandemic, more than 1,000 personnel at Bharat Biotech across India were busy developing, testing, manufacturing and distributing Covaxin.

“Our diligent efforts have resulted in an universal Covid-19 vaccine for adults and children alike, which can be administered repeatedly as booster doses without safety concerns. The Bharat Biotech team is extremely proud of its efforts to develop a novel Covid-19 vaccine for India and the world. These efforts to discredit our work will not deter us,” it added.

Maharashtra

Drug dealer arrested in Mumbai with 1.5 kg of charas (cannabis resin)

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On October 24, Crime Branch Unit 9 (Bandra West, Mumbai) intensified its crackdown on drug peddlers, resulting in the arrest of an individual involved in the sale of narcotics. The police had received information that the accused was selling charas (cannabis resin) and other intoxicating substances from his residence. Acting on this intelligence and following the guidance of senior officers, a team from Crime Branch Unit 9—accompanied by independent witnesses (panches)—raided the premises on October 24. During the operation, 1.505 kilograms of charas were seized in accordance with legal procedures; the estimated value of the contraband is 15 million rupees (1.5 crore INR) based on international market rates.

A case has been registered in connection with this incident under the NDPS (Narcotic Drugs and Psychotropic Substances) Act. One individual, aged 40, has been arrested. Additionally, another person has been identified as a wanted suspect, and a search is currently underway to locate him.

This notable operation was carried out under the supervision of Police Commissioner Deven Bharti, Joint Commissioner of Police (Crime) Anil Kumbhare, Additional Commissioner of Police Krishnakant Upadhyay, and Deputy Commissioner of Police (DCP) Nonath Dhole.

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Maharashtra

Lawrence Bishnoi gang shooters had practised shooting in the Aarey Colony forest before opening fire at Tiger Shroff’s residence.

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Following the firing incident involving Tiger Shroff, an investigation has revealed that a businessman in Pune and a film star in Mumbai were on Lawrence Bishnoi’s target list. The gang’s objective is to instill fear among the film industry and the business community in order to extort money—specifically, to collect protection money or ransoms. The primary goal of the Lawrence Bishnoi gang is not necessarily murder, but rather the creation of terror and fear within the film industry and among business circles.

Currently, 56 operatives of the Lawrence Bishnoi gang are incarcerated in various Mumbai jails; they have been linked to over 10 criminal incidents in Mumbai and Pune over the past 2–3 years. Targeting Bollywood is a key objective for the Lawrence gang, and they have been involved in conspiracies to target film actors specifically to spread fear and terror throughout the business community.

In the Tiger Shroff case, it has emerged that the shooters underwent firearms training in the Aarey Colony forest. A shepherd witnessed the shooters practicing and serves as an eyewitness; according to him, three to four individuals trained there, and he saw them firing weapons. New revelations continue to surface in the case involving Tiger Shroff, with the Crime Branch making significant progress in its investigation.

Weapons have also been recovered in connection with the matter. Furthermore, the interrogation of the shooters arrested by the police has led to the discovery of a link to Anil Pandit—a member of the Lawrence Bishnoi gang—with whom the shooters were in contact.

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Maharashtra

Major action by Mumbai ANC: Drug peddlers arrested.

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On October 25, the Anti-Narcotics Cell (ANC) of Mumbai claimed to have arrested individuals—who were also wanted in a murder case—while they were in possession of narcotics. During a patrol near the main gate of Shri Krishna Complex, opposite the National Park in Borivali West, Mumbai, the Ghatkopar unit of the ANC apprehended three individuals who were allegedly selling ‘MD’ (Mephedrone). Upon searching them, 1.028 kilograms of Mephedrone was recovered. The police registered a case (Kasturba Marg Police Station, Case No. 728/2026) under Sections 8(c) read with 22(c) and 29 of the NDPS Act, 1985. During the subsequent interrogation, it was revealed that the arrested individuals were also involved in a murder case. They had brought the narcotics from Nalasopara with the intent of selling them at this location.

The arrested individuals include a 28-year-old man, another 28-year-old man, and a 39-year-old man. A total of 1.028 kilograms of Mephedrone was seized from the three suspects.

This successful operation was carried out under the guidance of Police Commissioner Deven Bharti, Joint Commissioner of Police (Crime) Anil Kumbhare, Additional Commissioner Kant Upadhyay, and DCP Purnima Chougule-Shringi.

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