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.
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.
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 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.
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.
Firms could lose licence if products not launched within 6 months of approval.
The Pune-based Gennova Biopharmaceuticals has submitted phase 2 data of mRNA vaccine and has also completed the recruitment of phase 3 data.
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.
Favivir is the second drug developed by Hetero after Covifor (Remdesivir) used in the treatment of COVID-19.
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.
"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.
The drugs seized include 3,089 kilograms of charas, 158 kg of Methamphetamine and 25 kg of morphine.
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.
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.
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.
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
The needle-free vaccine will be available at private centres.
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.
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.
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.
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
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.
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.'