A study conducted by the Indian Council of Medical Research (ICMR) has observed that COVID-19 vaccination did not increase the risk of unexplained sudden death among young adults in India, the government informed Parliament on Friday.
SII has been asked to submit to the DCGI's office details of medication used in accordance with the protocol for management of adverse events.
The Maldives has deported 186 foreigners, including 43 Indians, after accusing them of committing crimes like visa violations and drug offences, according to a media report.
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.
DCGI, health ministry initiate dialogues with foreign regulators, try to understand global best practices
Baltimore-based Lupin Pharmaceuticals Inc is recalling 5,60,922 pouches of Mibelas 24 Fe (norethindrone acetate and Ethinyl estradiol tablets and ferrous fumarate tablets) in the US, as per the latest enforcement report by the USFDA.
The impact from NELM on the Indian pharmaceutical sector is estimated to be around Rs 6,000 crore.
The drug pricing regulator on Tuesday said it will fix the ceiling prices of over 300 medicines by the end of this month, a move that will come as a major relief to patients.
According to officials, this year there has been a three-fold increase in the total seizure, which was Rs 322 crore in 2021, Rs 347 crore in 2022 and Rs 1,021 crore so far in 2023.
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.
A statement issued by the WHO on Saturday said the suspension is in response to the outcomes of its post EUL (emergency use authorisation) inspection held between March 14-22, 2022 and the need to conduct process and facility upgrade to address recently identified GMP (good manufacturing practice) deficiencies.
The regulator had issued alerts in June and July of 2015.
'We have got enough internal accruals, and we are able to do acquisitions on our own.'
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 complaint seeking registration of a first information report on cheating, criminal conspiracy and other charges was filed in the court of Chief Judicial Magistrate Mukesh Kumar here on Tuesday by Tamanna Hashmi, who identifies himself as a social worker and is often in news for his numerous court complaints against politicians over various issues.
SII is the first indigenous company that has sought emergency approval for the vaccine developed along with global pharma giant AstraZeneca and Oxford University.
Even as the Supreme Court had recently dismissed the industry's plea against prices fixed by the regulator and its timely implementation, the National Pharmaceutical Pricing Authority has asked companies to pay the overcharged dues with 15 per cent interest.
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.
In a major escalation of the tussle with Punjab Chief Minister Bhagwant Mann, Governor Banwarilal Purohit on Friday warned that he could recommend President's rule in the state and also initiate criminal proceedings if his letters are not answered.
Nothing is going to change in a hurry unless attitudes change and punishments are speedy and fair, notes Ramesh Menon.
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.
Opposition parties targeted the Chief Minister Bhagwant Mann-led state government over the law and order situation and demanded that he step down on moral grounds.
Clinical trials in the country have witnessed a tremendous growth in recent years, a top government official said.
'The jungles of Doda covers about 250 km.' 'Sleeper cells are providing active help to the terrorists.' 'The terrain and situation is such that it is not possible to keep track of every inch.'
The DCGI's nod came after the subject expert committee on COVID-19 of the CSDCO last week recommended granting emergency use authorisation to Covovax for the age group of 7 to 11 years.
The top 300 pharmaceutical brands in the country will now bear a quick response (QR) code on their packaging to rein in spurious drugs and ensure better traceability.
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.
The Central Drugs Standard Control Organisation (CDSCO), the apex drug regulator, may soon ban the production and sale of three medicines in the country. The drugs - cisapride, phenylpropanolamine (PPA) and human placenta extracts - have been controversial medicines for their alleged adverse reactions for several years now.
Three employees of a Noida-based pharmaceutical firm, whose cough syrup is alleged to have led to the death of 18 children in Uzbekistan last year, were arrested on charges of manufacturing and sale of adulterated drugs, officials said.
The government has capped the trade margin on oxygen concentrators at 70 per cent in order to keep in check the price of the much in demand critical life saving component amid the second wave of the coronavirus pandemic. The trade margin has been capped at 70 per cent on price to distributor level on oxygen concentrators. In an official release, the chemicals and fertilisers ministry said the decision has been taken in view of the extraordinary circumstances arising due to the pandemic which has resulted in volatility in Maximum Retail Prices (MRP) of oxygen concentrators.
Of the 137,000 drug government tested 345 turned out to be fake.
In a video, Ramdev was allegedly heard saying, "Allopathy is a stupid science and medicines such as Remdesivir, Fabiflu, and other drugs approved by the Drugs Controller General of India have failed to treat COVID-19 patients." His remarks caused massive outrage and the IMA sent over a legal notice to him.
Drugs under exemption make up roughly 95 per cent of the antiretrovirals used by India's AIDS patients
The Directorate General of Civil Aviation (DGCA) has released a draft procedure that calls for testing pilots, other aviation personnel and crew members for psychoactive substances before they take to the skies. The Indian civil aviation regulator has sought comments from stakeholders over the next 30 days before issuing a regulation to this effect. Asking airlines and airports to do random checks on crew and air traffic controllers, DGCA proposed that violators be suspended for a minimum of three years or their licence be permanently cancelled as maximum punishment.
Bharat Biotech applied to the Drugs Controller General of India (DCGI) seeking permission for conducting phase 1 and phase 2 clinical trials of the intranasal vaccine following which the subject expert committee of the CDSCO on Tuesday deliberated on the application and recommended granting permission for phase 1 trial.
The industry feels that prices of active pharmaceutical ingredients (APIs) can go up in the range of 5-15 per cent.
There is no current evidence from randomised controlled trial to recommend any specific treatment for suspected or confirmed patients with COVID-19.
'That is a significant milestone for us and something we aspired for.'
