The joint inspections is to ensure the safety, efficacy, and quality of drugs available in the country
Most of the pharma units are failing in documentation, and validation processes, and many don't have full-fledged quality control laboratories.
Sandwiched between a Hero MotoCorp showroom and a shop that hires out cooking utensils is a small, dingy building that's been locked up. The non-descript two-room building is a manufacturing unit of Sresan Pharmaceuticals, the pharma company made its Coldriff cough syrup that has allegedly killed 25 children in Madhya Pradesh.
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.
The Punjab government has announced cash rewards for information leading to the arrest of 28 proclaimed offenders, including foreign-based gangsters, prompting criticism from the BJP regarding the state's law and order situation.
A probe has been initiated by India's drug regulator after the World Health Organisation (WHO) issued an alert saying cough syrups manufactured by an Indian firm could potentially be linked to the death of children in The Gambia, official sources said.
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.
As the Drugs Controller General of India (DCGI) is set to crack down on companies to ensure compliance with printing QR codes on top-selling brands to curb counterfeiting, top pharma companies say they welcome the regulator's mandate and that they are on track. They also view it as a positive step to ensure patient safety. Sheetal Arora, CEO of Mankind Pharmaceuticals, which has already adopted QR codes in 20 of their products, stated: "We strongly advocate for mandatory implementation of barcodes and QR codes on medicines as this initiative will not only protect patients but also strengthen the integrity of our healthcare system by reducing circulation of counterfeit drugs."
Mounjaro is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obesity) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition.
'TTP has vowed to take revenge for the attacks that Pakistan is carrying out against Afghanistan.' 'To diminish this threat, Pakistan is hitting Afghanistan hard.'
10 stocks from the Nifty 200 index that offer good growth potential and scope to deliver decent returns from current levels, based on brokerage estimates.
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.
Shares of Dr Reddy's Laboratories jumped 5.3 per cent on Thursday to Rs 1,217 apiece, making it the top gainer in the Nifty 50 and the BSE 100 indices. By comparison, the Nifty 50 was up 0.53 per cent at 25,289.
Most first-time investors may be better served by diversified options such as flexicap or multi-cap funds, which already hold pharma and healthcare stocks.
Firms could lose licence if products not launched within 6 months of approval.
Defence Minister Rajnath Singh praised the Indian Coast Guard's role during Operation Sindoor and highlighted its importance in national security on the occasion of its 50th Raising Day.
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.
Favivir is the second drug developed by Hetero after Covifor (Remdesivir) used in the treatment of COVID-19.
The Pune-based Gennova Biopharmaceuticals has submitted phase 2 data of mRNA vaccine and has also completed the recruitment of phase 3 data.
Unregistered sources of consignment raise quality questions.
Sixty firms' business worth Rs 1,000 crore at stake.
"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.
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.
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
Court rejects bid to introduce a linkage between regulatory approval of a medicine and its patent status.
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.
Avigan comes in a complete therapy pack of 122 tablets with a two-year shelf life.
'If you want to force the press into blacking out the Opposition's views or colour the news to your own liking, we will not do so.' 'We stand by freedom of expression. It is our Constitutional right. We stand by our Constitutional right.'
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 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.
There are just 1,500 drug inspectors responsible for more than 10,000 factories in 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.
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.
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
