Cdsco

MNC drugmakers push for 10-year exclusivity period for trial data

Global pharma companies represented by OPPI are urging the government to grant 10 years of exclusivity over regulatory trial data for first filers of novel drugs

Lilly's Donanemab gets CDSCO approval for early Alzheimer's treatment

Eli Lilly has secured CDSCO marketing authorisation for donanemab, an amyloid-targeting therapy for adults with early symptomatic Alzheimer's

Pharma units likely to face action for Schedule M violations: Experts

The one-year grace period for MSME drug manufacturers to comply with revised Schedule M norms has ended, with the CDSCO instructing state regulators to initiate inspections & action against violators

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

CDSCO issues draft guidelines to regulate medical device software

Draft guidelines aim to align India's medtech software framework with global practices; industry seeks more clarity on AI/ML evaluation and algorithm change management

WHO issues alert against 3 cough syrups linked to MP children's deaths

CDSCO had earlier informed the global health body that none of the syrups were exported to other countries

Death in a bottle: Toxic cough syrups once again prove fatal for children

Toxic cough syrups have once again proven fatal for children. This time, the tragedy has happened in India. Here's a look at why this sordid tale never seems to let up

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

Cough syrup deaths: Probe into Coldrif manufacturer exposes TNFDA lapses

The investigation against the Kanchipuram-based manufacturer of Coldrif cough syrup, linked to the deaths of children in Madhya Pradesh, has brought to light lapses by the Tamil Nadu Food and Drug Administration in enforcing basic regulatory norms, CDSCO sources said. Licensed in 2011 by the Tamil Nadu Food and Drug Administration (TNFDA), Sresan Pharma continued operations unchecked for over a decade despite its dismal infrastructure and multiple violations of national drug safety rules, they said. A recent inspection by the Central Drugs Standard Control Organisation (CDSCO) exposed the unit's appalling conditions and total non-compliance with Good Manufacturing Practices (GMP), the sources said. "The CDSCO has not been involved in any of the audits at Sresan Pharma. Since the CDSCO was not involved and the state FDA did not inform the CDSCO about this company in any way, this company was not part of any of the CDSCO databases," a source said. TNFDA officials could not be reached

Drug regulator begins pan-Indian inspection of cough syrup makers

The regulator has sought a list of cough syrup manufacturers from all states and UTs following reports of toxic contaminants linked to child deaths in Madhya Pradesh

Weight-loss drug Ozempic receives CDSCO approval for India launch

Experts say Ozempic's entry is expected to give a boost to the antiobesity market, estimated to be ₹752 crore. Of this market, semaglutide accounts for ₹426 crore

CDSCO flags 3 spurious drugs, 94 not of standard quality in August

CDSCO flagged three spurious drugs, including Pan D, Pan 40 and diazepam injection, and listed 94 medicines as not of standard quality in its August 2025 surveillance update

Mankind Pharma gets CDSCO nod for Phase 1 trials for novel autoimmune drug

Mankind Pharma has received CDSCO approval to initiate Phase 1 trials of MKP11093, a novel JAK-1 inhibitor for autoimmune disorders, as part of its expanding R&D pipeline

CDSCO flags 8 drugs as spurious, 134 not of standard quality in July

CDSCO flagged eight spurious drugs and 134 substandard formulations in July 2025, while Novo Nordisk reported theft of insulin and Wegovy batches during transit in India

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

Substandard quality in 3,104 drugs, 245 found spurious in FY25: JP Nadda

Since December 2022, the Central Drugs Standard Control Organisation (CDSCO) has inspected 905 drug manufacturing and testing units, resulting in 694 regulatory actions, Nadda said

CDSCO flags 4 drugs as spurious, 185 not of standard quality for June 2025

CDSCO has flagged four drugs as spurious and 185 others as not of standard quality for June 2025. The list includes antibiotics and heart disease medications. Investigations are underway

CDSCO revises export NOC guidance document for new drug formulations

The CDSCO has updated its guidelines for issuing export NOCs for new drug formulations, including relaxations for FDCs, research-oriented drug batches, and SRA approvals

CDSCO extends COPP application deadline for pharma units to August 15

Pharma firms get time till August 15 to file COPP applications online via ONDLS as CDSCO addresses onboarding challenges and industry pleas

Are generic medicines as good as branded ones? Here's what you should know

Are cheaper generic medicines really as good as expensive branded ones? Here's what doctors and pharma experts say about quality, safety, and trust