Drug Makers In India

CDSCO will permit drugmakers to begin testing samples as soon as applications are filed, shifting detailed scrutiny to later stages to shorten approval timelines and ease compliance

In a move aimed at speeding up approvals for new drugs, the government has changed the way testing permissions are granted, allowing companies to begin laboratory testing immediately after filing applications instead of waiting for detailed scrutiny. In an official circular, the country's apex drug regulatory authority, Central Drugs Standard Control Organization (CDSCO), said it has decided that "No Objection Certificate (NOC) for testing of drug samples at the designated laboratories (IPC, Ghaziabad; CDTL, Mumbai; CDL at CRI, Kasauli; or NIB, Noida) shall be issued immediately upon receipt of applications in the concerned division." Earlier, the regulator examined detailed specifications submitted by applicants before issuing permission for testing. These included "Type of formulation, dosage form, Critical Quality Attributes (CQAs), and general characteristics of the product," along with "Product development reports, forced degradation studies, and other relevant data, in ...

The health ministry has amended clinical trial rules to replace prior approvals for low-risk BA/BE studies with simple online intimations, a move aimed at cutting delays, easing compliance

In a gazette notification dated January 23, the Union health ministry proposed adding a new clause under Rule 95 of the Drugs Rules, 1945

Ozempic is also used off-label for weight loss due to its appetite-suppressing effects

Novo Nordisk cut Wegovy prices by up to 37 per cent across different doses to compete with rival drug Mounjaro from Eli Lilly

The government had directed drugmakers in late 2023 to upgrade plants to World Health Organization-recommended norms

Weight-loss drug rakes in ₹333 cr in cumulative sales since launch in March this year, leaving rival Wegovy behind

The decision to turn down requests from drug manufacturers for more time came after it was highlighted that Sresan Pharmaceutical, the company that produced Coldrif, did not upgrade its facilities

Balaji said it had tested its PG using US and Indian pharma standards at the behest of its non-pharma clients, and this was the reason why those standards were mentioned in its PG labels

A long-acting HIV jab promises near-perfect protection at just $40 a year, but 115 nations must wait for India's approval of generic production

Novo Nordisk to phase out insulin pens and cartridges in India; Eris, Wockhardt and Lupin prepare to capture Rs 600-800 crore market opportunity from FY26 onwards

From local giants Dr Reddy's Laboratories Ltd. to suppliers like Macleods Pharmaceuticals Ltd., Indian firms are preparing to make bulk drugs

India has issued first official guidelines for expert panels to bring consistency, speed, and transparency to drug and device approvals amid a broader regulatory overhaul

Drug major Cipla is preparing to foray into the weight management segment in India, its MD and global CEO Umang Vohra has said. The Mumbai-based firm is also strengthening its presence in the central nervous system (CNS) therapeutic area, he stated in his address to shareholders in the company's Annual Report for 2024-25. "Our efforts are rooted in understanding patient needs, reducing stigma, and delivering differentiated therapies for niche indications...obesity is emerging as a priority area for Cipla. With a clear strategic intent, we are preparing to enter the weight management segment in India, aiming to address the rising demand for effective obesity solutions," Vohra stated. Several domestic drug firms are developing drugs for weight loss to capitalise on the growing market for obesity and diabetes management. US drugmaker Eli Lilly & Co has already launched its anti-obesity drug Mounjaro in the country. Danish firm Novo Nordisk has also launched its anti-obesity drug ...

The drug, Acetaminophen Tablets (325 mg), is being recalled due to manufacturing deviations from Current Good Manufacturing Practices, following complaints of brown tablet discolouration

The Health Ministry is working with states to allow immediate suspension of licences for drugs declared substandard by labs, following a key recommendation from Drugs Technical Advisory Board

The 1.75 mg and 2.4 mg doses will be priced at ₹24,280, and 2.4 mg will be priced at ₹26,050 for a month

India's top drugmakers are reportedly sitting on their highest cash reserves in at least five years, up over 120% from FY20

Serum Institute and DNDi sign MoU to develop and scale a dengue monoclonal antibody vaccine with Phase 3 trials in India, Brazil and other endemic countries