A day after getting a show-cause notice from the Indian regulator, senior executives from Ranbaxy Laboratories approached the drug controller's office on Tuesday afternoon, it was learnt.
The company has received approval from the Drugs Controller General of India (DCGI) to market Itolizumab injection 25mg/5mL solution for emergency use in India for the treatment of cytokine release syndrome in moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19.
The World Health Organization has given five more months to the Drugs Controller General of India to upgrade its performance to international standards. The extension of the current deadline of October-end came after a visiting WHO team found the modernisation programmes of the Indian drug regulator on track.
An expert panel of the country's drugs regulatory authority had recommended against granting such approval to the firm at this stage just two days ago, officials said.
Indian pharmaceutical companies are stepping up their efforts to combat the problem of counterfeit drugs, employing a variety of strategies, from packaging innovations to engaging private investigation agencies. The stakes are high, as counterfeit medicines not only harm consumers but also tarnish the reputation of leading brands.
Bharat Biotech is targeting to manufacture one billion doses of its intra-nasal vaccine in 2022 which is under clinical trials now.
The DCGI arrived at the conclusion on Wednesday based on the recommendations of an independent expert committee which has also opined that compensation should not be paid to the volunteer, they said.
The magistrate court has remanded the accused Pakistani national Subair, who was arrested by the Narcotics Control Bureau to 14 days of judicial custody.
The company claims that when the Nitric Oxide Nasal is sprayed over nasal mucosa it acts as a physical and chemical barrier against the virus.
Regulator mentions Wockhardt as manufacturer but firm says it only markets drug.
The DCGI also directed Serum Institute of India to increase the safety monitoring of the subjects already vaccinated as part of the trial, and submit the plan and report.
Besides opposing the suspension of three medicines, the sector has also questioned the process adopted by the government.
The phase 3 clinical trial will cover around 28,500 subjects, aged 18 years and above, and it will be conducted in 21 sites across ten states, including Delhi, Mumbai, Patna and Lucknow.
Dominic Xavier offers his take on the COVID-19 vaccine which experts feel should be expected in mid-2021 only. Till then we have to get used to live with the virus.
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.
BE's Corbevax is the first such vaccine in India to be approved as a heterologous COVID-19 booster in the country.
There has been an "exponential" rise in the seizure of drugs in India in the last five years with the darknet and the maritime route emerging as the most preferred modes of trafficking, NCB director general S N Pradhan said on Tuesday.
The US Food and Drug Administration had in February approved Johnson & Johnson's COVID-19 vaccine that works with just one dose for emergency use.
The Drugs Controller General of India, the apex drug regulator, has included a new clause in the trial approval letters, making these firms also accountable for any possible adverse event.
Roadblocks ahead as these medicines could face new clinical tests, more scrutiny
Covaxin is being indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
SII is the first indigenous company that has sought emergency approval for the vaccine developed along with global pharma giant AstraZeneca and Oxford University.
In an exclusive interview with PTI video, the minister also said an extensive risk-based analysis is done continuously to ensure the production of quality medicines in the country, and the government and regulators are always alert to ensure that no one dies due to spurious medicines.
The solution to Manipur's problems lies in the government giving concessions to Meitis in jobs and education and to accept autonomy for the tribal dominated areas inhibited by the Kukis, suggests Colonel Anil A Athale (retd).
Codeine-based formulations are under the scanner for misuse as a narcotic product.
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.
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.
'I do not want every Tom, Dick and Harry to collect money. Is there any state control over this collection of funds via crowdfunding?'
The show-cause notice was issued following reports that human trials of the most promising COVID-19 vaccine candidate, being developed by the University of Oxford, have been put on hold after a United Kingdom participant had an adverse reaction to it.
"We have started the phase-III trials of the vaccine (candidate Covishield). We will administer dose to 150 to 200 volunteers," said Dr Muralidhar Tambe, Dean, Sassoon General Hospital.
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 Subject Expert Committee on COVID-19 examined the data and deliberated on the EUA application on Monday.
Pharma industry lauds idea, but suggests looser rules on ground
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 series of tweets after the Drugs Controller General of India (DCGI) approved Oxford's vaccine Covishield and Bharat Biotech's Covaxin for restricted emergency use, Modi said it will make every Indian proud that both the vaccines are made in India.
The Hyderabad-based firm completed clinical trials of the nasal vaccine with about 4,000 volunteers and there is no side effect or adverse reaction reported so far, company sources had said.
India's apex drug regulator has granted permission for conducting the phase II/III clinical trial of Bharat Biotech's Covaxin COVID-19 vaccine in the age group of 2 to 18 years, the Union Health Ministry said on Thursday.
The central government is importing COVID-19 vaccines and is in talks with COVID-19 vaccine manufacturers Pfizer and Johnson & Johnson, Union Minister of State for Home Affairs G Kishan Reddy said.
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