If we are to realise the full potential of biologics' ability to improve people's health, it is essential to encourage public policy and support R&D.
The government on Tuesday said the steps taken by the national pharmaceutical pricing authority for enforcement of prices fixed by it had resulted in recovery of an overcharged amount of Rs 80.08 crore (Rs 800.8 million) till October this year.
FDA had cancelled Ranbaxy's approvals to launch generic Nexium, Valcyte
The recent recalls come amid increased FDA scrutiny of medicines produced in India.
A bench of justices Sanjay Kishan Kaul and Indermeet Kaur took the plea of US pharma major on record and posted it for hearing before another bench on April 12.
Ranbaxy Laboratories on Thursday said that it had received final approval from US Food and Drug Administration to manufacture and market Ciprofloxacin.
The report also said that in past DEG outbreaks, manufacturers have been suspected of substituting DEG in the place of more expensive, pharmaceutical-grade solvents.
market, was today seized from an illegal drug manufacturing unit in Jalgaon district in north Maharashtra and six persons were arrested, Directorate of Revenue Intelligence officials said.
To ensure equal access to health care, the government must consider it in a holistic manner and improve all parameters.
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 Union home ministry said several steps have been taken to augment the production and supply of Remdesivir injections from 38.80 lakh units per month to 74 lakh units per month by early next month, and asked the states to ensure its seamless supply and transport.
The fees for facility inspection of foreign companies have been reduced
The USTR has placed India on its "priority watch" list for two years in a row, saying the country's patent laws unfairly favour local drug makers.
The US Food and Drug Administration (FDA) says it does not follow an India agenda.
A strong performance in the July-September quarter of 2023-24 (Q2FY24), an upward revision in the margin guidance and sustained momentum in US sales has helped the stock of pharmaceutical major Cipla gain about 2 per cent over the last two trading sessions. The brokerages have upgraded the earnings estimates for this financial year (FY24) by 6-9 per cent to factor in the improved margin guidance and sales in the US market. Led by the US market, which rose by 31 per cent, the company posted a 16 per cent growth in revenues.
When compared to the domestic sales of April 2019, the growth is around 37 per cent. However, compared to the previous month (March), the growth is 18.4 per cent.
Under the banner of the CII, domestic drug majors have approached Cabinet Secretary BK Chaturvedi for being allowed to present their views on the new pharmaceutical policy, scheduled to be discussed by the Union Cabinet on Thursday.
Two UK-based academicians, including an NRI, claim to have devised a way to invent new medicines and get them to market cheaply to enable millions in poor countries to be cured of infectious diseases.
Remdesivir is considered a key anti-viral drug in the fight against Covid-19. In addition, the government has taken three steps to ensure easy access of hospitals and patients to Remdesivir.
Hospitals to recover from sluggish Q3; diagnostics' growth rate at pre-Covid levels.
"Many of the pharmaceutical preparations subject to abuse are manufactured in India," affecting all sections of the population, the report stated.
The central government has for the first time allowed a private company, Bajaj Healthcare, to process opium to extract alkaloids used to make pain-killers, cough syrups, and even cancer drugs. Two government factories in Ghazipur, Uttar Pradesh, and Neemuch, Madhya Pradesh, do the work yet, processing some 800 tonnes of opium gum annually to extract alkaloids. The government on Tuesday gave Thane-based Bajaj Healthcare an initial contract to process 500 tonnes of opium gum annually and wants production to be at 800 tonnes per annum (tpa) in the next five years, indicating the state's exit from the highly-regulated sector.
Even as most of its large-cap pharmaceutical peers have struggled to stay above water on the returns front, Zydus Lifesciences has been one of the big outperformers within the sector over the past year with a return of over 30 per cent. The gains have come on the back of multiple triggers such as the scaling up of new product launches in the US market, clearance for its Moraiya (Gujarat) facility and steady performance in the domestic market. Though it has been the top pharma gainer in the 2022-23 financial year (FY23), brokerages continue to maintain their 'buy' stance, given the strong visibility in the US market.
In a major step to keep the price of essential medicines under control, the Union government on Friday informed the Supreme Court that 75 new medicines have been added to the essential drugs list after reviewing the pharmaceutical policy, 2002.
The combined sales of the branded versions of the products in the US is about $3.5 billion.
Strides Arcolab Ltd has signed an agreement with US-based bio-pharmaceutical company, Gilead Sciences, for manufacturing and distributing generic versions of anti-HIV drugs Truvada and Viread.
Once a difficult market to crack, in recent years, China has relatively opened up its drug market, enacting reforms and speeding up approval time.
Currently, the govt directly caps prices of 348 formulations at the average price of all medicines in a particular segment with at least 1% market share
A day after getting a show-cause notice from the Indian regulator, senior executives from Ranbaxy Laboratories approached the drug controller's office on Tuesday afternoon, it was learnt.
Sun Pharmaceutical Industries Ltd on Thursday said its Halol facility in Gujarat has been listed under import alert by the USFDA with products manufactured at the unit now are subject to refusal of admission in the US market. The development follows an inspection of the facility by the US Food and Drug Administration (USFDA) from April 26 to May 9, 2022. "We now wish to inform you that the company has received a communication from the USFDA stating that the facility has been listed under Import Alert," Sun Pharma said in a regulatory filing.
India's drug regulator Drugs Controller General of India has granted permission to Mumbai-based pharmaceutical company Cipla to import Moderna's COVID-19 vaccine for restricted emergency use in the country, official sources said on Tuesday.
The drug maker will lose some incentives if its membership is suspended, sources in Pharmexcil said.
Legal experts and official sources said the alleged submission of fake documents can also lead to criminal charges against Novartis.
As many as 150 applications are stuck at evaluation stage, says official.
Six decades and more later, we are now captives of our identities. Every poll is based on elaborate calculations of electability of candidates on the basis of their castes and other narrow definers. That, along with voter promiscuity, is what defines our political culture, which remains stubbornly resistant to any change, asserts Shreekant Sambrani.
FDA had also issued warning letters to Ranbaxy's Paonta Sahib and Dewas facilities as it found extensive problems and deviations from manufacturing norms.
Himalaya Drug Company said on Tuesday that it is setting up a Rs 165 crore (Rs 1.65 billion) research and development and manufacturing unit on the outskirts of Bangalore to be completed by 2005.
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.
