Pharma major Dr Reddy's Laboratories delivered a muted operational performance in the fourth quarter of financial year 2024-25 (Q4FY25), even as revenue growth remained healthy. Lower gross margin performance and muted domestic growth are key concerns. Most brokerages have a "Sell" or "Reduce" rating as there are uncertainties related to the development of a new product portfolio and the launch timelines.
"We will never approve anything if there is even the slightest safety concern. Vaccines are 110 per cent safe. Some side effects like mild fever, pain and allergy are common for every vaccine. "It (rumours of impotency) is complete nonsense," V G Somani, Drug Controller General of India said.
This is the world's first DNA-based vaccine against the coronavirus, and this three-dose vaccine when injected produces the spike protein of the SARS-CoV-2 virus and elicits an immune response, which plays a vital role in protection from the disease as well as viral clearance
Unregistered sources of consignment raise quality questions.
Sixty firms' business worth Rs 1,000 crore at stake.
The drugs seized include 3,089 kilograms of charas, 158 kg of Methamphetamine and 25 kg of morphine.
The DCGI said it has no objection in respect of 'Extension of Shelf Life of Covishield Vaccine' in multi-dose glass vial (10 dose-5ml) from six months to nine months.
Court rejects bid to introduce a linkage between regulatory approval of a medicine and its patent status.
The government has been stringent with pricing changes. Prices of 651 essential medicines came down from April 1, 2023 by 6.73 per cent with the government capping ceiling prices of these drugs.
Covovax is likely to be available on the portal in a few days at a price of Rs 225 per dose plus applicable GST.
Avigan comes in a complete therapy pack of 122 tablets with a two-year shelf life.
Samples of the cough syrup have been taken from the manufacturing premises in Noida and sent to the Regional Drugs Testing Laboratory (RDTL) in Chandigarh for testing, Mandaviya said.
The Drug Controller General of India has sent a letter to the Glenmark seeking clarifications on pricing as well as claims of therapeutic efficacy. While Glenmark has claimed this drug is effective in comorbid conditions like diabetes, hypertension, according to protocol summary (of clinical trials) the trial was not designed to access the Fabiflu in comorbid conditions.
The needle-free vaccine will be available at private centres.
MSD Pharmaceuticals, the wholly owned Indian subsidiary of Merck, is awaiting approval from the Drug Controller General of India to launch a human papillomavirus vaccine to treat cervical cancer. The company has already conducted clinical trials.
COVAXIN, developed by Hyderabad-based Bharat Biotech in collaboration with Indian Council of Medical Research and National Institute of Virology, has got the nod for human clinical trials from the Drug Controller General of India
There are just 1,500 drug inspectors responsible for more than 10,000 factories in India
According to the ministry, chemical ethylene glycol was found in a batch of syrup during laboratory tests.
Biocon Ltd ill seek Drug Controller General of India's approval for its novel monoclonal antibody indicated towards the treatment of head and neck cancer, Biomab EGFR.
The Narcotics Control Bureau (NCB) on Saturday said it has arrested Jaffer Sadiq, a Tamil Nadu-based alleged dealer of narcotics, in connection with an international drugs trafficking investigation case.
Earlier, Jaslok Hospital had issued an advisory to its doctors to avoid prescribing drugs manufactured by Ranbaxy.
India's drug regulator has initiated a probe and sought further details from the WHO after the global health body issued an alert that cough syrups manufactured by an Indian firm could potentially be linked to the death of children in Gambia.
The ED will probe if money earned from the illicit narcotics trade was laundered to create movable and immovable assets by the accused. The investigation will run parallel to the NCB probe, the sources said.
An intranasal vaccine as a booster dose would be easier to administer in mass vaccination campaigns and has the potential to prevent transmission.
Indian Council of Medical Research Director General Balram Bhargava had on Monday recommended the use of hydroxychloroquine for treating healthcare workers handling suspected or confirmed coronavirus cases.
Wockhardt said, the drug regulator suspended the manufacture, sale or distribution of fixed dose combination of Dicyclomine Hydrochloride IP 10mg
'Safety is my first priority.' 'I need to ensure that any drug or vaccine that our citizens get is first safe.'
The move has come days after the state government announced to form a special investigation team to probe into the death of Disha Salian, the former manager of late actor Sushant Singh Rajput.
The parties intend to produce over 300 million doses of the vaccine in India per year.
Favipiravir is the only oral anti-viral treatment approved in India for potential treatment of patients with mild to moderate Covid-19 disease.
Russia's Sputnik V vaccine is currently being manufactured in India by Dr Reddy's Laboratories.
The DCGI's approval came following recommendation by the Subject Expert Committee of the Central Drugs Standard Control Organisation.
The FDA Maharashtra on Friday lodged an FIR against Snapdeal.
Legal experts and official sources said the alleged submission of fake documents can also lead to criminal charges against Novartis.
Maya Chemtech India Pvt Ltd supplied propylene glycol used in Marion Biotech's cough syrups that were found to be "not of standard quality", according to the regulator.
The drug comes in powder form in a sachet, which is taken orally by dissolving it in water. It accumulates in the virus-infected cells and prevents virus growth by stopping viral synthesis and energy production.
FabiFlu is the first oral favipiravir-approved medication in India for the treatment of COVID-19. Favipiravir can be used for coronavirus patients with co-morbid conditions such as diabetes and heart disease with mild to moderate COVID-19 symptoms.
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