The FDA had imposed a ban on the company's Waluj plant in May.
Baltimore-based Lupin Pharmaceuticals Inc is recalling 5,60,922 pouches of Mibelas 24 Fe (norethindrone acetate and Ethinyl estradiol tablets and ferrous fumarate tablets) in the US, as per the latest enforcement report by the USFDA.
With all major US export-oriented drug manufacturing plants in the country up for inspection in 2022, some estimates peg that at least 20-30 per cent of the new product launches lined up for the US will be subject to on-site inspection by the US Food and Drug Administration (USFDA). The last two years saw limited physical inspections due to travel restrictions during the pandemic. "Pre-Covid, the frequency and number of inspections of manufacturing plants in India by USFDA had increased significantly," analysts from ICICI Securities Research noted. "With growing ANDA filings, especially for complex products. "We expect this trend to return with the environment normalising," analysts from ICICI Securities Research noted.
The move has come days after the state government announced to form a special investigation team to probe into the death of Disha Salian, the former manager of late actor Sushant Singh Rajput.
These items will remain under essential commodities segment till June-end, a move aimed at ensuring availability at reasonable prices and cracking down on hoarders/black marketeers.
They said after examining and analysing the adverse event reports, causal relationship and all related details shared by or to be shared by the WHO, the committee will advise and recommend further course of action to the Drugs Controller General of India (DCGI).
The medical devices, which have been in high demand during the Covid-19 pandemic, will now see a drop in prices, as the earlier margins were up to 709 per cent for some of these products.
As per the clinical trial protocol approved, 150 subjects with mild to moderate COVID-19 will be randomised in the study in a 1:1 ratio to Favipiravir with standard supportive care or standalone standard supportive care. Treatment duration is a maximum of 14 days and the total study duration will be a maximum for 28 days from randomisation.
'Gift-giving' - from free dinners and drug samples to promotional merchandise - seems to be driving drugmakers' marketing - a marketing prescription deeply entrenched in the industry. This is a well-oiled racket that sees pharmaceutical (pharma) companies 'gifting' doctors to push their respective drugs under the guise of marketing. But is there a cure in sight to end this unhealthy alliance? The recent controversy following the income-tax raids on Bengaluru-based drugmaker Micro Labs, makers of popular paracetamol brand Dolo-650, has brought this to the fore, again.
In contrast with their strong performance in 2020 and 2021, pharmaceutical and healthcare funds experienced a decline in 2022, with returns plummeting by an average 9.8 per cent. This trend has continued in the current year, with year-to-date return remaining in the negative (-4.9 per cent). In the past three months, pharma funds have been hit hard, experiencing a 7.9 per cent decline.
The termination of the pact comes after the deal with the Brazilian government for supply of 20 million doses of the vaccine landed in controversy and attracted investigation by authorities in that country.
The government has allowed import and export of COVID-19 vaccines without any value limitation, in order to ensure speedy clearance and distribution. The Central Board of Indirect Taxes and Customs (CBIC) has amended the regulations to facilitate the import/export of COVID-19 vaccines through courier, at locations where the Express Cargo Clearance System (ECCS) is operational. "Imports and exports of vaccines in relation to COVID-19 has been allowed without any value limitation," said the amended Courier Imports and Exports (Electronic Declaration and Processing) Amendment Regulations, 2020.
It is the generic version of Teva Women's Health's Seasonale tablets
Facing a steep rise in raw material and interest costs, pharmaceutical companies have sought an increase in prices of regulated medicines, saying otherwise they may be forced to curtail production of certain medicines that have become unprofitable.
The regulator has given the company 15 days to take corrective measures and report back to it.
Once a difficult market to crack, in recent years, China has relatively opened up its drug market, enacting reforms and speeding up approval time.
The Brazilian health regulator's decision comes after the vaccine maker informed the South American country about the termination of its pact with its partners in that country.
Dr Malhotra, who has demanded a full safety review into the use of AstraZeneca's Covid vaccine, told PTI Covishield "should never have been rolled out in the country in the first place".
The guidelines listed several services including government and private offices that will be out of bounds during the period, while exempting establishments such as hospitals, ration shops, dairies, banks, insurance offices, and print and electronic media. Delivery of all essential goods including food, pharmaceuticals, medical equipment through e-commerce has also been exempted from the purview of the lockdown.
The drug regulator recently asked some domestic companies to cut prices of insulin while MNCs, which are major players, are allowed to set their own price for the drug.
The government's agenda also includes the Cryptocurrency and Regulation of Official Digital Currency Bill, 2021.
Department of Pharmaceuticals asks NPPA to review Eli Lilly product prices.
The Indian Pharmaceutical Alliance has approached regulator for a dialogue to understand the concern raised by it
"It has been decided that for approval of COVID-19 vaccines in India for restricted use in emergency situation which are already approved for restricted use by US Food Drug Administration, European Medicines Agency, UK Medicines and Healthcare products Regulatory Agency, Pharmaceuticals and Medical Devices Agency Japan or which are listed in WHO Emergency Use Listing and which are well established vaccines from the stand point that millions of individuals have already been vaccinated with the said vaccines, the requirement of conducting post approval bridging clinical trials and of testing every batch of vaccine by CDL, Kasauli can be exempted, if the vaccine batch/lot has been certified and released by National Control Laboratory of country of origin," it said.
During the meeting, scheduled to be held through video conference at 6 pm on Tuesday, the Department of Biotechnology will make a presentation and also coordinate with all the participants, sources added.
The epidemiologist estimates that more than 60 per cent of China and 10 per cent of Earth's population are likely to be infected over the next 90 days with deaths likely in the millions.
The recalled drug bottles were distributed by Caraco Pharmaceutical Laboratories, Ltd in the US while manufactured in India by Sun Pharmaceutical Industries Ltd.
Torrent to buy Ranbaxy's anti-bacterial generic
Releasing a report titled 'Profiting from Pain' in Davos, the rights group further said as the cost of essential goods rises faster than it has in decades, billionaires in the food and energy sectors are increasing their fortunes by $1 billion every two days.
The National Pharmaceutical Pricing Authority, which regulates the prices of medicines, has identified around 70 anti-cancer drugs, including anti-breast cancer medication Letrozole and anti-blood cancer drug Imatinib, for detailed price analysis.
An expert panel of the country's drugs regulatory authority had recommended against granting such approval to the firm at this stage just two days ago, officials said.
The government said that "in exercise of extraordinary powers in public interest, conferred by paragraph 19 of the DPCO, 2013", the ceiling prices of 21 key formulations had been increased. These formulations include common medicines like BCG vaccines, penicillin, malaria and leprosy medicines (Dapsone), life-saving drugs like Furosemide (used to treat fluid build-up due to heart failure, liver scarring, or kidney disease), vitamin C, some common antibiotics, and anti-allergy medicines.
'We expect to get the approval in the next few weeks,' says Deepak Sapra, CEO, API and pharmaceutical services, Dr Reddy's Laboratories (DRL).
'Pfizer India has submitted an application on December 4 to the DCGI seeking emergency use authorization for its COVID-19 vaccine in India'
Drug Controller General G N Singh said the regulator is addressing all the pending issues to liberate the pharma sector and to simplify export regulations which will be reflected in the forthcoming policy.
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In a letter to health minister Harsh Vardhan, the Indian Pharmaceutical Alliance, an industry body representing leading pharma companies, including Sun Pharma, Lupin, Dr Reddy's Labs, Cadila Health and Glenmark, stressed the need for an out-of-court settlement with health activists fighting for the rights of clinical trial participants.
There are just 1,500 drug inspectors responsible for more than 10,000 factories in India
The transition of Class A and Class B medical device makers to the licensing regime by October 1 seems to be an uphill task with several small and medium manufacturers saying they are still awaiting the audit from the government authorities. If the licenses don't come through, either due to lack of audits or MSME units not clearing the audits, then a few thousand small-scale medical device units will face the issue of business continuity in three weeks. Class A medical devices are those with low to moderate risk to the patient or user (surgical dressings for example), while Class B medical devices refer to devices with moderate risks that require special controls (catheters for example).
Formal warning to Indian unit of deficiencies noted during inspection at facility near Chennai; firm says will remedy
Glaxo Group 'neglected the duty of making timely disclosures' to the stock exchanges the BSE and the NSE, on various occasions, the Securities and Exchange Board of India said in its order.
