Drug Makers In India

Granules India gets sole first-to-file status for narcolepsy drug Lumryz

The drugmaker's generic version of Lumryz could benefit from 180-day exclusivity in the US market if it meets regulatory requirements

GLP-1 rush exposes capacity crunch at India's drug manufacturing firms

Demand for GLP-1 drugs such as semaglutide is exposing capacity gaps across peptide APIs, sterile fill-finish facilities, injector devices and glass cartridges

Drug companies seek NPPA price revision for cancer drugs amid shortage

Oncology drugmaker says soaring platinum prices, higher import duties and lengthy import approvals have made production financially unviable, worsening shortages of key chemotherapy medicines

CDSCO flags spurious liver drug, 169 others fail quality tests in April

CDSCO flags one batch of a liver drug as spurious and identifies 169 drugs and formulations as not of standard quality during April surveillance

Drugmakers seek price cap as input costs surge amid West Asia conflict

Small pharma firms have flagged a steep surge in raw material and packaging costs amid global disruptions, warning of supply risks and seeking price controls

India's challenge to evergreening: 2026 may test drug patent regime

Experts say 2026 could be a crucial year for drug patents, with the likely emergence of fresh disputes over follow-on patents

CDSCO allows immediate lab testing of drugs to speed up approvals

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

CDSCO modifies norms for testing permissions to speed up drug approvals

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 ...

Centre scraps prior approval system for BA/BE studies of low-risk drugs

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

Centre mandates blue chip on all antimicrobial brand labels to counter AMR

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

Dr Reddy's gets regulatory nod to sell generic version of Ozempic in India

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

Generic drugmakers to slash price plans as Novo cuts Wegovy rates

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

CDSCO tells drugmakers to meet global norms by Jan after cough syrup deaths

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

Mounjaro India's bestselling drug in October with ₹100 crore sales

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

Centre refuses deadline extension for pharma firms after Coldrif deaths

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 Amines accused of making pharma-grade chemical without licence

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

One shot every six months: India could change HIV prevention forever

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

Indian drugmakers gear up for ₹600-800 cr insulin pen market post-Novo exit

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

India's bulk drug makers start preparing for Ozempic patent expiry

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

India launches formal rules to fix, streamline drug and device clearances

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