Latest news with #DrugsControllerGeneralofIndia
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Business Standard
19 hours ago
- Business
- Business Standard
Wockhardt eyes $9 bn market opportunity for novel antibiotic Zaynich
Mumbai-based pharmaceutical major Wockhardt, which is set to launch a new class of antibiotic, Zaynich, in India this year, estimates a total addressable market opportunity of $9 billion. This includes a $7-billion market in the US and Europe, and a ₹17,000-crore opportunity in India. The company's stock rose 2.4 per cent on the BSE on Thursday following an investor presentation outlining its growth plans for the next three to five years. Zaynich (or WCK 5222) is a key research candidate in Wockhardt's pipeline. It has completed global Phase 3 clinical trials, demonstrating a 20 per cent higher (statistically superior) composite cure rate compared to Meropenem, the current gold standard in antibiotics. Wockhardt claims Zaynich is the first new class of antibiotic in over 30 years to treat gram-negative infections. The drug has already saved 51 lives under compassionate use, including three in the US, where patients had failed all existing therapies. Zaynich is indicated for complicated urinary tract infections (UTIs), hospital-acquired and ventilator-associated bacterial pneumonia, bloodstream infections, and complicated intra-abdominal infections. The company expects approval from the Drugs Controller General of India (DCGI) shortly and plans to launch the drug in the second half of this financial year. Wockhardt has completed a pre-NDA (New Drug Application) meeting with the US Food and Drug Administration (USFDA) in May and plans to file in Q2FY26, targeting a potential launch in FY27. Regulatory filings in the EU and emerging markets are scheduled for the second half of FY26. Wockhardt estimates that around 1.1 million patients in India may benefit from Zaynich, while 371,000 carbapenem-resistant cases in the US and Europe are potential candidates. Overall, there are 4.3 million hospitalised cases involving key gram-negative pathogens in the US and EU. The firm sees a combined addressable patient pool of 2 million across India, the US, Europe, and China. Apart from Zaynich, Wockhardt is also betting on other antibiotics in its portfolio, such as Miqnaf (Nafithromycin), and its biotechnology portfolio, including insulin products. Miqnaf, already launched in India, treats community-acquired bacterial pneumonia (CABP) and upper respiratory tract infections. It has received Qualified Infectious Disease Product (QIDP) status from the USFDA, signifying unmet medical need, and Breakthrough Medicinal Product (BMP) designation in Saudi Arabia. Miqnaf targets a ₹10,800-crore market in India, with over 96 million potential prescriptions. In the biosimilars segment, Wockhardt is focusing on diabetes care and sees significant opportunity arising as Danish major Novo Nordisk phases out human insulin cartridges. This creates a ₹450-crore opportunity in India and a $157-million market across emerging economies. With only three major players in India, including itself, Wockhardt expects to benefit substantially. The company is doubling its diabetes biosimilars capacity over the next three years to meet growing demand, targeting business growth of 20–25 per cent.
Mint
2 days ago
- Business
- Mint
India's drug regulator plans overhaul of Schedule H for prescription medicines
New Delhi: Drugs Controller General of India (DCGI), the country's top drug regulator, is planning a complete overhaul of medicines listed under Schedule H of the Drugs and Cosmetics Rules, 1945, which governs the sale of prescription drugs, said an official aware of the matter and documents reviewed by Mint. Also Read | Key drugs, diagnostics run short in public health centres, govt raises alarm The proposed revamp is driven by concerns, including a rise in antimicrobial resistance (AMR) from self-medication and rampant use of antibiotics purchased over the counter without prescription, the official said. Schedule H includes drugs that cannot be purchased or sold on retail without a doctor's prescription. This overhaul will involve updating the list of prescription drugs by incorporating new medicines and formulations that have been introduced in the market in the recent past. 'The issue related to making suitable reforms in the drug regulatory system has been in discussion for quite some time now. The exercise is part of India's fight against irrational use of antimicrobial medicines, which are used to prevent and treat infectious diseases in humans, animals and plants, including antibiotics, antivirals, antifungals and antiparasitics," said the official on the condition of anonymity. Also Read | What America has got wrong about gender medicine In 2022, a high-level expert committee was constituted by the health ministry to review and revise Schedule H Drugs to recommend comprehensive changes in the drug regulatory regime to reflect global best practices as well as domestic requirements. Remdesivir, dexamethasone, favipiravir, ivermectin and mebrofenin are some of the drugs that are proposed to be added to Schedule H. Right now, there are around 536 drugs under Schedule H. The committee had discussed the existing regulatory framework in detail and noted that the drugs that are not included in Schedule G, H, H1 and X can be easily sold in the country without prescription of a Registered Medical Practitioner (RMP) and it is 'not in public interest", according to the documents reviewed by Mint. Also Read | ICMR gets a breakthrough in attempts to develop first indigenous Nipah virus medicine 'There are many drugs used for various indications like diabetes, TB, heart disease, pain killers etc which are put in special categories like anti-diabetic, anti-pain relief, anti-depressants, anticoagulant drugs, and cardiovascular drugs of the Drug Rule. However, these drugs should fall in schedule H. So, efforts are being made to streamline this," said the official. The expert panel recommended a revamp of the Schedule H. 'Schedule H includes drugs of various categories which require prescription of RMP for their retail sale. The Schedule H needs to be updated regularly to incorporate the new drugs introduced in the market from time to time as well as to review the prescription status of different drugs in the present context. Such regular updates are crucial in the current context to address various regulatory challenges leading to irrational use of drugs, including antibiotics and development of anti-microbial resistance," the documents showed. Wrong or over-use of these medicines can lead to the emergence of antimicrobial resistance (AMR), which is hard to treat and can cause further infections. The committee has proposed more than 700 drugs to be added to the Schedule H drugs list in addition to the existing drugs, as per the documents. The committee also reviewed various aspects of the drugs like their indication, route of administration, international prescription status, abuse or misuse potential, human/ veterinary use, therapeutic/ prophylactic usage etc. When the committee reviewed Schedule G, it opined that drugs mentioned under this list bear caution that 'it is dangerous to take this medicine except under medical supervision". While Schedule G drugs carry a strong caution about medical supervision, the rules governing their sale did not, in the past, explicitly mandate an RMP prescription for every single sale, unlike Schedule H drugs. The committee has recommended the addition of several categories of drugs, namely cardiovascular drugs, neurological drugs, respiratory drugs, anesthetic drugs, antiemetic drugs, immunological drugs, genito-urinary drugs, non-steroidal anti-inflammatory drug, and all sterile formulations of any drug to schedule H.
Hans India
2 days ago
- Business
- Hans India
Biocon gets CDSCO nod for generic diabetes drug
New Delhi: Biocon on Tuesday said it received approval from the government authorities for a generic diabetes medication – Liraglutide drug substance. Itswholly-owned subsidiary Biocon Pharma has received approval for its Liraglutide drug product (6 mg/ml solution for injection in pre-filled pen and cartridge), from the Drugs Controller General of India (CDSCO). The approval is for the generic version of Victoza, indicated for the treatment of insufficiently controlled Type 2 Diabetes Mellitus in adults, adolescents and children aged 10 years and above, as an adjunct to diet and exercise, the company said in a regulatory filing. "The approval of our first vertically integrated GLP-1 in India, Liraglutide, is another significant step forward in expanding access of this product to patients suffering from diabetes," Biocon CEO and MD Siddharth Mittal said. India has one of the highest number of people with diabetes globally, with estimates exceeding 77 million cases, and expected to rise further, he added. "We are now gearing up to launch the product expeditiously through our commercialisation partners in India," Mittal stated.
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Business Standard
3 days ago
- Business
- Business Standard
Biocon gets CDSCO approval for generic diabetes medication 'Liraglutide'
Biotech firm Biocon on Tuesday said it has received approval from the government authorities for a generic diabetes medication. The company has received approval for its Liraglutide drug substance and its wholly-owned subsidiary Biocon Pharma has received approval for its Liraglutide drug product (6 mg/ml solution for injection in pre-filled pen and cartridge), from the Drugs Controller General of India (CDSCO). The approval is for the generic version of Victoza, indicated for the treatment of insufficiently controlled Type 2 Diabetes Mellitus in adults, adolescents and children aged 10 years and above, as an adjunct to diet and exercise, the company said in a regulatory filing. "The approval of our first vertically integrated GLP-1 in India, Liraglutide, is another significant step forward in expanding access of this product to patients suffering from diabetes," Biocon CEO and MD Siddharth Mittal said. India has one of the highest number of people with diabetes globally, with estimates exceeding 77 million cases, and expected to rise further, he added. "We are now gearing up to launch the product expeditiously through our commercialisation partners in India," Mittal stated. Biocon shares were trading 0.81 per cent up at Rs 336.75 apiece on BSE. (Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)
Business Standard
3 days ago
- Business
- Business Standard
Biocon gets CDSCO approval for Liraglutide drug substance
Biocon said that it has received an approval from the Drugs Controller General of India (DCGI), under the central drugs standard control organisation (CDSCO), for its Liraglutide drug substance. Additionally, its wholly owned subsidiary, Biocon Pharma, has received CDSCO approval for the Liraglutide drug product (6 mg/ml solution for injection in pre-filled pen and cartridge). The said approval is for the generic version of Victoza, indicated for the treatment of insufficiently controlled type 2 diabetes mellitus in adults, adolescents and children aged 10 years and above, as an adjunct to diet and exercise. The approval was received from the CDSCO under the recently formulated 101 route that enables recognition of approvals granted by established and referenced serious regulatory authorities. Siddharth Mittal, chief executive officer and managing director, Biocon, said: The approval of our first vertically integrated GLP-1 in India, Liraglutide, is another significant step forward in expanding access of this product to patients suffering from diabetes. India has one of the highest number of people with diabetes globally, with estimates exceeding 77 million cases, and expected to rise further. The approval enables us to address a critical need by making this drug available, and aligns with Biocons mission to provide affordable, lifesaving medications to those who need it the most. We are now gearing up to launch the product expeditiously through our commercialization partners in India. Biocon is an innovation-led global biopharmaceutical company focused on improving affordable access to complex therapies for chronic conditions like diabetes, cancer and autoimmune diseases. It has developed and commercialized novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets, as well as generic formulations in the U.S. and Europe The companys consolidated net profit surged 154.2% to Rs 344.50 crore on 12.8% jump in net sales to Rs 4,358.10 crore in Q4 FY25 over Q4 FY24. The counter shed 0.45% to end at Rs 334.05 on the BSE.
