Roche expects to start selling Actemra by April 2009, company sources said. India will be the second country to launch the drug, Japan being the first. The Indian drug regulator Drug Controller General of India usually approves a new drug marketing application based on safety and efficacy data cleared by regulators in the US, EU and other developed countries.
At least a dozen global firms, including Roche, Pfizer and Astra Zeneca got a nod from the Drugs Controller General of India to conduct over 50 clinical trials on Indian volunteers this month, official data reveals. The global clinical research outsourcing market is projected to touch $23 billion by 2011, with consultancy firm KPMG estimating that India will corner 15 per cent of this in two years.
These brands belong to about 320 drugs of leading Indian pharmaceutical companies. The Drug Controller General of India's (DCGI's) office feels that these have been launched without its approval.
'The elimination of terrorists does not imply the neutralisation of terrorism. That terrorist ecosystem continues to thrive in Kashmir.'
The Drugs Controller General of India will take a final call on the recommendation. If approved, it will be the third COVID-19 vaccine to be available in India.
The Border Security Force (BSF) is training specialized 'drone commandos' and 'drone warriors' for modern warfare, with plans to deploy them in missions like Operation Sindoor. A 'School of Drone Warfare' has been inaugurated to provide training in UAV operations, anti-drone warfare, and surveillance.
Firms could lose licence if products not launched within 6 months of approval.
Various industry bodies have sought immediate government intervention through the imposition of anti-dumping duties, claiming India has seen a surge in imports of Chinese goods over the past two weeks.
Over 20 drug companies marketing anti-obesity drug sibutramine under a variety of brand names are likely to soon face a ban on selling the medicine.
The Pune-based Gennova Biopharmaceuticals has submitted phase 2 data of mRNA vaccine and has also completed the recruitment of phase 3 data.
Favivir is the second drug developed by Hetero after Covifor (Remdesivir) used in the treatment of COVID-19.
The show-cause notice dated February 8 by DCGI V G Somani cited a Delhi high court order dated December 12, 2018, which prohibits online sales of medicines without a licence.
"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 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.
Avigan comes in a complete therapy pack of 122 tablets with a two-year shelf life.
Covovax is likely to be available on the portal in a few days at a price of Rs 225 per dose plus applicable GST.
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 drugs seized include 3,089 kilograms of charas, 158 kg of Methamphetamine and 25 kg of morphine.
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.
There are just 1,500 drug inspectors responsible for more than 10,000 factories in India
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
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 needle-free vaccine will be available at private centres.
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.
Earlier, Jaslok Hospital had issued an advisory to its doctors to avoid prescribing drugs manufactured by Ranbaxy.
According to the ministry, chemical ethylene glycol was found in a batch of syrup during laboratory tests.
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.
An intranasal vaccine as a booster dose would be easier to administer in mass vaccination campaigns and has the potential to prevent transmission.
Wockhardt said, the drug regulator suspended the manufacture, sale or distribution of fixed dose combination of Dicyclomine Hydrochloride IP 10mg
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.
'Safety is my first priority.' 'I need to ensure that any drug or vaccine that our citizens get is first safe.'
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