The US Food and Drug Administration (FDA) says it does not follow an India agenda.
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.
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.
AstraZeneca has stressed that patient safety is its "highest priority" and pointed out that regulators around the world "consistently state that the benefits of vaccination outweigh the risks of extremely rare potential side effects".
Fundraising via initial public offers (IPOs) dropped 52.2 per cent to $147.2 billion in the first eight months of calendar year 2023 (CY23), suggests a recent report by GlobalData, a London-based analytics and consulting company. At the country level, the report suggests, India topped the charts with 152 transactions worth $3.8 billion during this period, primarily due to a higher number of SME IPOs, followed by the US with 99 deals totaling $16 billion, while China ranked third with 88 transactions worth $32.3 billion. "An analysis of GlobalData's Deals Database reveals that there were 750 IPO listings registered with an aggregate deal value of $147.2 billion in the first eight months of 2023 on the stock exchanges worldwide.
Indian drug firms continue to work closely with the FDA, and most have also appointed consultants to help them grasp the regulatory minutiae in the US.
It brought more drugs under control, cracked foreign firms' patents and introduced new regulations when MNCs acquire Indian cos.
Margaret A Hamburg, the first commissioner of the US Food and Drug Administration (US FDA) to visit India officially, will meet heads of major domestic pharma companies such as Ranbaxy, Wockhardt, Cadila Healthcare and Lupin in New Delhi.
The National Pharmaceutical Pricing Authority has decided to have one price for basic utility condoms and the other for pleasure condoms.
India's drug regulator has initiated a probe and sought further details from the WHO after the global health body issued an alert that cough syrups manufactured by an Indian firm could potentially be linked to the death of children in Gambia.
As many as 150 applications are stuck at evaluation stage, says official.
The mutual fund (MF) industry had an action-packed 2023 as it tackled the scrapping of tax benefits for debt fund investors and surging flows into equity funds.
Dr Reddy's gets warning from US health regulator
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.
According to the ministry, chemical ethylene glycol was found in a batch of syrup during laboratory tests.
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.
The move is in line with the NPPA's recent policy of putting a cap on prices.
Maya Chemtech India Pvt Ltd supplied propylene glycol used in Marion Biotech's cough syrups that were found to be "not of standard quality", according to the regulator.
A joint team of the state and the Centre inspected the unit and found 12 violations or deficiencies.
Indian drug firms get a shot in the arm in the $12 bn Australian drug market as the Therapeutic Goods Administration (TGA), Australia agrees to accelerate the drug approval process in that country for Indian players who already have an approved plant and product from one of the stringent regulatory authorities like US, EU or Canada. From current sales of $340 mn, the Indian firms can see a significant upside in sales; felt Dinesh Dua, former chairman of the Pharmaceutical Exports Promotion Council of India (Pharmexcil), and the MD of Nectar Lifesciences. He highlighted that only 12 percent of the Australian drug market is generic, as against 80-90 per cent in the US or EU. Of this $1.5 bn generic drug market in India, Indian companies have a small share.
'However, we have seen weakness in our active pharmaceutical ingredients business.'
Global Pharma Healthcare is recalling entire lots of eye drop linked to vision loss in the US, according to the US Food and Drug Administration. The Chennai-based company is recalling all lots of artificial tears lubricant eye drops distributed by EzriCare, LLC and Delsam Pharma to the consumer level due to possible contamination, the US health regulator said in a statement. "The Centres for Disease Control and Prevention (CDC) alerted FDA to an investigation of a multi-state cluster of Verona Integron-mediated Metallo--lactamase (VIM)- and Guiana-Extended Spectrum--Lactamase (GES)- producing carbapenem-resistant Pseudomonas aeruginosa (VIM-GES-CRPA) infections possibly associated with the use of the artificial tears manufactured by Global Pharma Healthcare," USFDA said.
'There is no reason why we should break this business up.'
With regulatory uncertainties clouding the future of online pharmacies, deals in the space are showing signs of slowdown, as also fresh investment from private-equity (PE) firms and venture capitalists (VCs). The data from Venture Intelligence shows so far in 2023 (as of June 13) there has been one deal with PE-VC funding. In 2022 there were four, a sharp fall from the 12, totalling $1,520 million, the sector had attracted in 2021.
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.
Sputnik V is already approved in India and Sinovac is unlikely to come in as it does not meet the criteria.
The initial public offering (IPO) market has seen some momentum of late with robust responses to recent issues. However, only some have been able to ride the wave. So far in 2023, 23 companies have let their approval granted by the markets regulator - the Securities and Exchange Board of India (Sebi) - lapse.
Defining "modern medicine" for the first time, the National Medical Commission (NMC), in its code of conduct, has introduced a major change, proposing the use of "Med Dr" as a prefix for those registered under the NMC Act, 2019, as practitioners of modern medicine.
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.
India and the US on Thursday said they are looking forward to the reconvening of the India-US Trade Policy Forum later this year to further enhance trade relationship and identify new areas for engagement.
The US on Thursday raised concerns over India's Personal Data Protection (PDP) Bill and draft non-personal data governance framework, claiming these could potentially threaten innovation and economic growth. In its latest 'Special 301' Report, the US Trade Representative (USTR) kept India on the priority watch list, maintaining the country remains one of the world's most challenging major economies with respect to protection and enforcement of intellectual property (IP). In December 2021, a joint parliamentary committee released a report recommending changes to the PDP Bill, 2019, that could undermine important IP protections in India.
Anti-infectives like Ivermectin, Mupirocin and Meropenem have also been added to the list, taking the total drugs under it to 384.
A healthy growth in India's services segments has helped the country's total exports and imports of goods and services to cross the $800 billion mark during the first half of 2023, despite a slowdown in global demand, think tank GTRI said in a report on Monday. According to the analysis of the Global Trade Research Initiative (GTRI), exports of goods and services rose by 1.5 per cent to $385.4 billion during January-June this year, as against $379.5 billion in January-June 2022. Imports, however, dipped by 5.9 per cent to $415.5 billion during the six months of this year, as against $441.7 billion in January-June 2022.
The company claims that when the Nitric Oxide Nasal is sprayed over nasal mucosa it acts as a physical and chemical barrier against the virus.
Ranbaxy was asked to sell all products containing Leuprorelin which are marketed and supplied under brand name Eligard.
Indian drug firms like Marksans Pharma, Aurobindo Pharma, Zydus and Jubilant are recalling products in the US market, as per the latest enforcement report by the US Food and Drug Administration (USFDA). While Marksans Pharma is recalling diabetes drug, Zydus Pharmaceuticals (USA) is recalling drug which is used to reduce stomach acid. Similarly, Aurobindo Pharma (USA) is recalling pain relieving drug, while Jubilant Cadista is recalling a medication used to treat schizophrenia.
The proposed acquisition is expected to close by the end of 2014, subject to approvals from Indian Courts and the anti-trust body in India and the US
Covaxin is being indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
The joint inspections is to ensure the safety, efficacy, and quality of drugs available in the country
