The DTAB Sub-Committee will do a fresh review of the banned FDCs on case-by-case basis to verify their safety before recommending an action to the govt
The CDSCO looks to give show case notices along with cancelling their licenses for the offence. These companies were apparently selling combination drugs to treat diabetes and fungal infections without the required approval.
The government has been doling out initiatives in its efforts to promote the use of generic drugs
The major chronic therapies like anti-diabetic posted growth of 9.1 percent, cardio 5.9 percent and central nervous system (CNS) 5.4 percent in February, respectively.
Most of the observations relate to deficiencies in maintaining equipment, cleanliness of equipment and utensils, sterility, employees training, lab controls and computer controls
The market breadth was in favour of the advances with 1246 stocks advancing while 358 decllined and 402 remained unchanged. On the other hand, in the BSE, 1527 stocks advanced and 546 declined and 87 remained unchanged.
Addressing the special plenary on pharmaceutical and biotechnology on the first day of UP Investors Summit, Patel said, "The summit will pave the path for development in the state. Development of UP will speed up development of the country."
Prices of Drug Releasing Stents -- small wire-mesh structures used to treat blocked arteries -- have been slashed to 27,890 rupees ($433.82), from 30,180 rupees, the National Pharmaceuticals Pricing Authority of India said in a statement.
In a BSE filing, it said Strides Pharma Global Pte. has received approval from the United States Food and Drug Administration (USFDA) for tenofovir disoproxil fumarate tablets, 300 mg.
The BSE Healthcare rose 1.25 percent in the past week, the benchmark Sensex gained 1.23 percent.
The US drug regulator has cleared record number of abbreviated new drug applications (ANDAs) in 2017, as it aims to expand competition in generic drugs and there by reduce healthcare costs for US citizens.
Here's a roundup of the key developments in the pharma sector this week.
“Revenue of domestic pharma companies is seen growing at 9 per cent per annum over the next three fiscal years ending 2020. Exports, which account for nearly 45 per cent of industry revenue, will see another year of a tepid one per cent growth in fiscal 2018, but recovering thereafter,” Crisil said in a note today.
Pharmaceutical firms have suffered a setback as the Supreme Court has favoured re-examination of 349 fixed dose combination (FDC) medicines, a ban on which was set aside by the Delhi High Court.
The committee will look at the claims made by the respective companies on any additional therapeutic claims made by companies on new drugs, and provide a recommend separate ceiling price of the scheduled formulation or retail price of a new drug.
The BSE Healthcare index dropped 2.4 percent in the past week, while the BSE Sensex declined 1.3 percent
In separate notifications, the drug price regulator said it has notified ceiling prices of 13 formulations, while revising the same for 15 formulations.
The CDSCO started the probe after receiving a complaint from another pharma company that is carrying out clinical trials for the same drug and awaiting a launch.
"Alvogen has received final approval and is the first to market generic equivalent to oseltamivir phosphate, 6 mg/ml powder for oral suspension in the United States," Natco Pharma said in a regulatory filing.
The company said it is holding extraordinary general meeting of its shareholders on November 29 to ratify the fund raising proposal.
Pharma major Lupin has received final approval for its carbidopa tablets, used for treatment of idiopathic Parkinson's disease, from the United States Food and Drug Administration (FDA).
Chemicals and Fertilisers ministry in a statement issued last week had said that the Department of Pharmaceuticals (DoP) is considering a change in the method of approving prices of new drugs.
The drug will be manufactured at the group's formulations manufacturing facility at Moraiya in Ahmedabad, it added.
Cadila Healthcare, Dr.Reddy’s, Aurobindo are the companies to watch out for with half of their revenues coming from US.
The company has received approval from the US Food and Drug Administration (USFDA) to market the fesoterodine fumarate extended release capsules in strengths of 4 mg and 8 mg, it said in a BSE filing.