Page 3 - Indian Pharma

Lupin announces launch of world's first FDC drug for chronic lung disease

Lupin Vilfuro-G is the only FDC that uniquely combines Vilanterol, Fluticasone Furoate, and Glycopyrronium Bromide for the long-term management and treatment of moderate to severe COPD

Ryzneuta for chemotherapy-induced neutropenia receives USFDA approval

Acrotech Biopharma is preparing to commercialise Ryzneuta in the United States in the near future

India must save the reputation of its pharma industry

When both our trading partners and our own doctors raise questions about the quality of medicines we make, what is the government doing to assuage these valid concerns?

Mankind Pharma sees 21% profit surge in Q2 despite consumer health hurdles

The delayed season not only affected anti-infectives but also related sub-therapies such as respiratory, cough and cold, gastro, and vitamins, says Juneja

Govt mulling guidelines for OTC medicines; move to reduce burden on doctors

Industry players present at the event highlighted that the OTC market offers a major business opportunity, but it needs transparent and clear regulations

Biocon, Juno Pharma ink pact for commercialisation of Liraglutide in Canada

Under the agreement's terms, Biocon will be responsible for obtaining regulatory approvals for Liraglutide and will subsequently manage the manufacturing and distribution of the product within Canada

Cytiva opens new manufacturing facility and experience center in Pune

The newly unveiled manufacturing facility in Pune will produce bioprocessing equipment, including tangential flow, virus filtration, and inactivation systems

Indian pharma exports to Iran decline thanks to its lower rupee reserves

Indian pharma exports to Iran have declined from $205.1 million in FY20 to $59.14 million in FY23. Iran's rupee reserves have depleted as India ceased oil imports from the country in mid-2019

Cipla's US subsidiary InvaGen gets 5 inspectional observations from USFDA

The inspection was a routine current Good Manufacturing Practices (cGMP) inspection and a Pre-Approval Inspection (PAI) for a site transfer product within InvaGen

Generic medicines: Indian pharma market is at crossroads of systemic shift

Companies must start preparing their business models to adjust to the reality of the shift to medical practitioners prescribing only generic molecule names

Fierce competition among new drug brands for share of India market

The competitive intensity is high between brands, at a time when volume growth in the domestic pharma market is on a slow lane

All provisions of medical devices rules to come into force from Oct 1: DCGI

Medical devices of all four categories (A, B, C, and D) will be brought under the regulation by October 1 and as of now only two groups (A and B) are being regulated, Drugs Controller General of India (DCGI) Rajeev Singh Raghuvanshi said on Wednesday. Speaking to reporters on the sidelines of the 9th International Pharmaceutical Exhibition (iPHEX) being organised by the Pharmaceuticals Exports Promotion Council (Pharmexcil) here, Raghuvanshi said the regulations would ensure quality in the production of medical devices. "In the medical devices, we are categorising into four groups. Two groups (A and B) are already notified. C and D are left which will happen from October 1," he said. The Union Cabinet on April 26 approved the National Medical Devices Policy, 2023 to give a thrust to the sector with quality controls. The market size of the medical devices sector in India is estimated to be USD 11 billion (approximately Rs 90,000 crore) in 2020 and its share in the global medical devi

Contaminated drugs: USFDA uncovers failures in India's pharma factories

The $50 billion sector is under the spotlight after a number of recent scandals linked to smaller, privately-held Indian companies, including the deaths of dozens of children in Gambia and Uzbekistan

Health min urges stakeholders to build trust in quality of Indian drugs

Union Health Minister Mansukh Mandaviya urged all the stakeholders on Sunday to steadfastly work towards building trust and confidence in the quality of Indian drugs, cosmetics and medical devices in domestic and export markets. It is of critical importance to ensure that the country's regulatory mechanisms are of impeccable standards that are sustained over time and space, Mandaviya said as he inaugurated a two-day "chintan shivir" on "Drugs: Quality Regulations and Enforcement" in Hyderabad. "How can we ensure that the confidence of the consumers of pharmaceuticals manufactured in India is upheld? I urge all the stakeholders to steadfastly work towards making the Indian drugs regulatory system among the best in the world, which could be emulated by other countries," he said. In his inaugural address, Mandaviya underlined the focus of the deliberative forum, saying, "The chintan shivir is a platform for all the stakeholders in the pharma and health sectors to deliberate on pathways

Lupin Pharma launches Lurasidone Hydrochloride Tablets in US

The generic equivalent of Latuda tablets has been launched in the US markets

Indian pharma R&D spends stay stagnant three years after pandemic downturn

Spends are now lower relative to sales than before Covid-19, stand at 4.4% of net sales, compared with 20% in the US

Cough syrup-linked deaths: Manufacturing activities stopped at Noida firm

All manufacturing activities at Marion Biotech's Noida unit have been stopped in view of reports of contamination of its cough syrup, Dok-1 Max, Union Health Minister Mansukh Mandaviya said on Friday. Further investigation in connection with the death of 18 children in Uzbekistan allegedly linked to the cough syrup is going on, the minister said in a tweet. "Following inspection by @CDSCO_INDIA_INF team in view of reports of contamination in cough syrup Dok1 Max, all manufacturing activities of Marion Biotech at NOIDA unit have been stopped yesterday night, while further investigation is ongoing," Mandaviya said. Government sources said Uzbek officials reached out to India on Thursday night regarding the cough syrup-linked deaths and seeking a thorough probe in the matter. A legal representative of the company had said on Thursday that the manufacturing of Dok-1 Max has stopped "for now". Marion Biotech does not sell Dok-1 Max in India and its only export has been to Uzbekistan, a

After Gambia, now Uzbekistan alleges Indian cold drug killed its children

Noida-based Marion Biotech's Dok-1 Max anti-cold medicine under scanner after the Central Asian nation blames it for 18 deaths

Zuventus first in world to launch aviptadil for ARDS commercially

Discovered in 1970, the drug was tested on severe Covid-19 patients on DCGI's direction

Who is responsible for the quality of Indian pharma exports?

WHO has issued a global alert over four cough syrups made by an Indian pharma company, for alleged death of 66 children in The Gambia. Who are responsible for quality checks of Indian pharma exports?