'WHO & an independent group of experts are scheduled to meet next week to carry out the risk/benefit assessment and come to a final decision whether to grant Emergency Use Listing to Covaxin,' the global health body tweeted.
NPPA denies price hike on Sanofi, Novartis, and Allergan products.
Wockhardt is recalling select drugs in the US, which were under import restrictions from the USFDA.
According to the recommendations of the Subject Expert Committee (SEC) meeting held on July 30, which have been approved by the Drugs Controller General of India (DCGI), Sputnik-Light is the same as the component-1 of Sputnik V and as its safety and immunogenicity data in the Indian population has already been generated in a trial here, there seems to be inadequate data and justification for conducting a separate, similar trial.
Whistle-blower Dinesh Thakur will speak on Made-in-India drugs at an event in Washington.
Medicines, including antibiotics, contraceptives and anti-diabetic drugs, were found to be out of stock at various places around Delhi.
National security advisor Ajit Doval on Friday suggested that various central armed police forces of the country should have "jointness" and interoperability among themselves like the ongoing plan for the defence forces.
Leading drug firms Aurobindo Pharma, Sun Pharma and Jubilant are recalling different products in the US market for various reasons, as per the latest enforcement report by the US Food and Drug Administration (USFDA). While Aurobindo Pharma is recalling Cyanocobalamin Injection, which is used to treat and prevent lack of vitamin B12, Mumbai-based Sun Pharma is recalling a drug used to increase the production of natural tears in eyes. Similarly, Jubilant Cadista is recalling a drug which is used to treat different inflammatory conditions.
A recent report has suggested that future patent expires in the cardiac and anti-diabetes space would form a good opportunity for smaller firms, given their franchise in these segments.
The company has received a communication from the Medicines and Healthcare Products Regulatory Agency, United Kingdom, whereby the agency has decided to withdraw the previously issued GMP Certificate to the company's manufacturing facility situated at Kadaiya, Nani Daman, Wockhardt said in a filing to the Bombay Stock Exchange.
'There is no reason why we should break this business up.'
The GoM has proposed to cap prices of these medicines at the weighted average price of drugs with a minimum of one per cent market share, officials aware of the development said.
Industry is gathering scientific data to approach the regulator, DCGI, for a review of the suspension order.
Sharad Pawar says final draft will go to Cabinet before Tuesday.
This increase is despite the decreased growth of drug sales in the US - the world's largest market - which has seen a tightening of regulations and aggressive competition.
The idea is to ensure drug companies do not gold-plate drugs to exorbitantly raise prices while introducing those in the market.
NPPA will begin analysing pricing trends of 74 bulk drugs that come under the government-notified price-controlled list every quarter.
The National Pharmaceutical Pricing Authority will soon notify prices of as many as 150 packs of essential medicines in line with the new pharma pricing policy, according to official sources.
The department of pharmaceuticals turned down a review petition by drugmaker Cipla against a price fixation order by the National Pharmaceutical Pricing Authority, slashing the price of Dytor Plus, a medicine for kidney and heart ailments.
Several companies, including Indian units of Abbott Laboratories and Pfizer Inc, and domestic firms like Cipla Ltd and Macleods Pharmaceuticals, went to the Delhi High Court to try to get the ban lifted.
The claims were made after the Income Tax department had on July 6 raided 36 premises of the Bengaluru-based Micro Labs Ltd. across nine states.
The trial is being conducted in three phases by segregating children into categories according to their age. The first trial was started in the age group of 12 to 18 years followed by the age group of 6 to 12. Trials for children between the ages of and 2-6 years are currently undergoing trials.
The Wall Street Journal has reported that the SEC has contacted many investment banks whose analysts cover generic drug-maker Mylan, asking about a meeting the company hosted last September with those analysts and a group of investors.
.jpg)
The company has launched the Decitabine for injection in the strength of 50 mg in the US market following approval by the United States Food & Drug Administration of Dr Reddy's abbreviated new drug applications, it said in a statement.
The Canadian health and drug regulator Health Canada has asked Ranbaxy Pharmaceuticals Canada (RPCI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL) to withdraw its generic, 25 microgram per hour strength, fentanyl pain-relief patches from the Canadian market due to safety concerns.
The court had provided a conditional relief to Nestle India.
Drug firm Zydus Cadila on Thursday said it has applied for emergency use authorisation (EUA) with the Indian drug regulator for its three-dose COVID-19 vaccine ZyCoV-D, and plans to manufacture 10-12 crore doses annually.
commercial airlines and air navigation service providers have to carry out random drug tests on at least 10 per cent of their flight crew and air traffic controllers every year.
Justice Rajiv Sahai Endlaw allowed 454 petitions moved by various pharma and healthcare majors, like Pfizer, Glenmark, Procter and Gamble and Cipla, challenging the government's March 10 notification banning the FDCs, saying the decision was taken by the Centre without following procedure prescribed in the Drugs and Cosmetics Act.
This could also be India's first vaccine for children aged 12 years and above as the company has conducted trials on the age group. The decision, however, lies with the regulator, reports Sohini Das
In an exclusive interview with PTI video, the minister also said an extensive risk-based analysis is done continuously to ensure the production of quality medicines in the country, and the government and regulators are always alert to ensure that no one dies due to spurious medicines.
The western world had largely considered India to be a production hub, and also, a good potential geography for clinical trials, and a big market. But in Covid-19 research, Indian companies and government researchers are also researching new drug candidates and potential vaccines, says Prosenjit Datta.
The first 100 beneficiaries of such foreign vaccines shall be assessed for seven days for safety outcomes before it is rolled out for further immunisation programme within the country, the Union health ministry said.
The case was earlier heard by a different vacation bench which had on June 10 asked Sharma to substantiate his 'unfounded allegations' that the Indian pharma major was allegedly manufacturing and selling adulterated medicines.
Orchid Chemicals & Pharmaceuticals on Monday said it has received US health regulator's approval to sell anti-epileptic levetiracetam tablets in the American market.
Notwithstanding the fact that the country's pharmaceutical (pharma) pricing regulator has allowed a 12 per cent price increase for medicines listed under the National List of Essential Medicines (NLEM) in 2023, analysts and industry insiders predict that the overall domestic pharma industry will only witness a price hike of 5-6 per cent. This is attributed to higher competitive intensity in the market. Krishnakumar V, executive director and chief operating officer (CEO) of Eris Lifesciences, a domestic-focused pharma company, noted that the NLEM segment experienced growth suppression of around 150 basis points due to price reductions during the January to July period this year.
Samples of the powder for babies did not conform to standard pH value during a laboratory test, the regulator said.
Glenmark said it along with its US-based partner has got the US health regulator's nod to manufacture and market two oxycodone products, used for treating moderate to severe pain, in the American market. The company's US arm, Glenmark Generics Inc and Lehigh Valley Technologies (LVT) have received US Food and Drug Administration nod for Oxycodone immediate release capsules, the company said in a filing to the Bombay Stock Exchange.
