Since two cases against clinical trials started in SC, govt is overly cautious.
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.
Indian companies, key players in the field of generic medicines, especially for AIDS, may benefit from a $15-billion US programme aimed at combating the deadly disease in 14 countries.
Indian pharmaceutical companies are stepping up their efforts to combat the problem of counterfeit drugs, employing a variety of strategies, from packaging innovations to engaging private investigation agencies. The stakes are high, as counterfeit medicines not only harm consumers but also tarnish the reputation of leading brands.
Analysts are expecting pharmaceutical companies to post sales growth of 10-11 per cent in the second quarter this financial year while the Ebitda (earnings before interest, tax, depreciation, and amortisation) margins are anticipated to improve by about 110 basis points. Ebitda improvement will be led by lower input costs because prices of active pharmaceutical ingredients (APIs) are 5-15 per cent lower year-on-year (Y-o-Y). Axis Capital said sales growth would be around 10 per cent, of which growth in the India market would be 11 per cent or so.
Favivir is the second drug developed by Hetero after Covifor (Remdesivir) used in the treatment of COVID-19.
With this, 1,289 kilograms of cocaine and 40 kilograms of hydroponic Thailand marijuana worth Rs 13,000 crore have been seized by the law enforcement agencies within a fortnight in Delhi and Gujarat, sources said.
India and the United States will finalize the contours, schedule of negotiations, and terms of reference for a proposed bilateral trade agreement (BTA) during a three-day meeting beginning Tuesday. The agreement is expected to be finalized in two tranches, with the first phase focusing on goods trade. The US team, led by Assistant US Trade Representative for South and Central Asia Brendan Lynch, will be in India from March 25-29 to discuss the agreement. Both countries are aiming to conclude the first phase of the agreement by fall 2025.
Anti-diabetic drug makers are looking to launch cheaper drugs targeting patients in rural areas.
Indian pharmaceutical companies have made major strides in adhering to stringent US Food and Drug Administration (USFDA) norms in 2024, with data suggesting a decline in the number of adverse classification outcomes of inspections across biologics, drugs, and devices. In 2023, the USFDA conducted 225 inspections, which led to 18 cases of Official Action Indicated (OAI) and 117 cases of Voluntary Action Indicated (VAI).
The US Trade Representative noted that India's average applied tariff rate stood at 17% per cent, the highest of any major world economy.
Before making any decision, have an open discussion about trust and how to rebuild it in your relationship, says rediffGURU Ravi Mittal, while counselling a young man suspecting his partner of cheating on him.
Drug major Cipla on Tuesday said it has launched drone-powered deliveries of critical medicines - cardiac, respiratory and other essential chronic therapies - to hospitals and pharmacies across Himachal Pradesh in partnership with Skype Air Mobility, a Gurugram-based drone delivery company. Cipla is the first among large Indian pharmaceutical companies to adopt drone-based deliveries to facilitate expedited supply to stockists in remote areas, it claimed. The Mumbai-based firm said the use of drones will support the on-time delivery of its medicines to chemists and clinics in remote areas, and minimise risks of affecting cold chain products due to temperature excursions.
Rising penetration of trade generic medicines is eating into the value growth of the domestic pharmaceutical market, showed a recent analysis. According to a Kotak Institutional Equities analysis, 70-110 basis points (bps) annual dent is expected from trade generics and Jan Aushadhi on Indian Pharma Market (IPM) growth at least until FY27-28 (see chart). Trade generic medicines are those that are not pushed into the market through doctor promotions.
Overall slowdown in the economy and growing volumes of unbranded generic medicines in the domestic market are behind poor sales.
Indian drugmakers' domestic sales of ready-to-take medicines in January-March could be lower than expected as distributors suspended stocking in anticipation of a new value-added tax system coming into force, analysts and industry members said.\n\n\n\n
Wockhardt said it is launching the product immediately in the US market.
An acute drug shortage in the US and stable pricing along with product launches are likely to boost revenues of India's pharmaceutical companies during the first quarter of this financial year, analysts said. Most brokerages estimate a top line growth of around 14-15 per cent, with earnings before interest, taxes, depreciation, and amortisation (Ebitda) growth of 24-30 per cent for Q1 of FY24. Hospitals are, however, likely to report lower occupancy rates, and diagnostics companies may witness an impact from delayed monsoon.
The Budget has given signals that India is sensitive to the US needs and willing to walk the extra mile, but if need be, we should respond in equal measure as a sovereign nation, notes Ajay Srivastava.
FabiFlu is the first oral favipiravir-approved medication in India for the treatment of COVID-19. Favipiravir can be used for coronavirus patients with co-morbid conditions such as diabetes and heart disease with mild to moderate COVID-19 symptoms.
The solution to Manipur's problems lies in the government giving concessions to Meitis in jobs and education and to accept autonomy for the tribal dominated areas inhibited by the Kukis, suggests Colonel Anil A Athale (retd).
A team of central agencies and the Uttar Pradesh drug department had carried out an inspection at the firm's office in Noida on December 29 and taken six more samples for testing.
Gearing up for Trump 2.0 era, Chinese President Xi Jinping on Tuesday cautioned there will be no winner in a tariff or tech wars between China and the United States and vowed that Beijing would firmly safeguard its interests.
358 of 413 drug patent applications for the disease in India are from top multinationals. An analysis of pharma patent applications pending with the patent office by the group, which did not wish to be identified, has put the number of cancer drug patent applications at 413. Of these, 358 came from top multinationals like Novartis, Aventis, Bristol Myers Squibb, Pfizer, Boehringer, Roche and Abbot.
Swiss pharmaceutical major Hoffmann-La Roche's patents rights over Hepatitis C drug Pegasys has been challenged by public interest groups at the Indian Patent Office.
With this, the anti-drugs agency has so far arrested 17 people in the case, including Bollywood superstar Shah Rukh Khan's son Aryan Khan, and some "high-profile organisers" belonging to a Delhi-based event management company.
The Mumbai-based firm said it has signed an pact with the Department of Health, Government of Brazil and Farmanguinhos, the largest public sector undertaking in health care in Brazil, to supply the drug.
Riluzole is indicated for the treatment of amyotrophic lateral sclerosis.
Drug firm Strides Acrolab on Tuesday said it is in a position to supply Oseltamivir Capsules, the only available medicine against Influenza A HINI virus (Swine Flu), to meet the demand both from domestic and overseas market.
The interim order was passed by the court on Wednesday on a plea filed by Roche Scientific on January 19 this year. The generic name of the drug is Erlotnib, which Roche markets as Tarceva and Cipla as Erlocip. Ahead of the next hearing, the court has asked Cipla to maintain records of sales of Erlocip.
The US health regulator has pulled up drug major Sun Pharma for manufacturing lapses, including failure to follow appropriate written procedures designed to prevent microbiological contamination of drug products, at its Gujarat-based plant. In a warning letter, the US Food and Drug Administration (USFDA) pointed out various lapses at the Halol plant which produces finished pharmaceutical products. "This warning letter summarises significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals... Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated," the USFDA stated.
'In this assembly election, Muslims here will vote for one who works, but also one who safeguards their identity.' 'Their existence is more important they feel, than a faulty light meter. So yes, a Muslim representative will make a difference.'
Drugs worth more than Rs 5,300 crore were seized and 102 people involved in illicit narcotics trade apprehended by the Gujarat police in the last one-and-a-half years, the state legislative assembly was informed on Tuesday.
Donald Trump's Presidency of the United States will open new opportunities for India though certain sectors, especially pharma and IT, may face the heat if the incoming president decides to impose restrictions on imports and H1B visa regulations, experts said on Wednesday. Prime Minister Narendra Modi's friendly relationship with Trump will have a positive bearing on Indo-US relations but India may have to adapt its strategies to maintain cooperation in areas of mutual interest.
The inspection at Marion Biotech started at around 12 pm and continued for over 10 hours during which six more samples of the syrup were taken, they said.
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