Cdsco

Centre puts stricter controls on pregabalin sales over abuse concerns

India has moved pregabalin to Schedule H1, tightening prescription and record-keeping norms after states flagged widespread misuse of the nerve pain drug for intoxication

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

First wave of generic semaglutide approvals opens up India market

India has entered the first phase of generic semaglutide approvals, with CDSCO clearing multiple formulations for obesity and diabetes, paving the way for lower-cost GLP-1 therapies

CDSCO flags 7 drugs as spurious, 167 fail quality tests in Dec 2025

CDSCO has flagged seven drug batches as spurious and listed 167 others as not of standard quality in its December 2025 surveillance, covering common medicines for BP, pain and allergies

Centre to restrict cough syrup sales by unlicensed village pharmacists

Draft amendments propose removing "syrup" from Schedule K exemptions, tightening over-the-counter sales in small villages after Madhya Pradesh cough syrup deaths

Weak regulation hurt public policy in 2025; fixing it is 2026's big task

From aviation to finance, regulatory failures marked India's economy in 2025, exposing weak state capacity and the urgent need to redesign how regulators function

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