CDSCO

DTAB recommends continuing GMP exemptions under revised Schedule M for disinfectants, medical gases and gelatin capsules, citing limited relevance of strict norms

Regulator plans to cut delays by allowing direct submission of Form 40 applications to DCGI, aiming to improve efficiency in drug import approvals

DCC discusses stricter norms to bar firms with cancelled licences from reapplying and proposes public disclosure of inspection findings to strengthen pharma regulation

Regulator flags rise in unlicensed IVF device sales as smaller fertility centres turn to cheaper alternatives amid pricing pressures and lack of awareness

CDSCO flagged four drugs as spurious and 194 as not of standard quality in February 2026, including widely used medicines, as part of routine surveillance

Firms may shift to doctor outreach, CME programmes and patient support initiatives as CDSCO bars advertising of GLP-1 drugs ahead of semaglutide patent expiry

CDSCO's DTAB panel proposes boxed warnings on emergency contraceptive pills and inclusion under Schedule K to ensure safer usage while retaining over-the-counter availability

These drugs, though approved for type 2 diabetes, have witnessed a surge in demand globally due to their weight-loss effects

CDSCO has mandated online submission of applications for licences to manufacture and sell r-DNA-origin drugs through the ONDLS portal to streamline regulatory processes

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 ...

AIOCD has urged the Prime Minister to ban AI-generated prescriptions, alleging they are being misused by unregulated e-pharmacies to sell restricted medicines, posing a serious public health risk

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

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

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 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

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

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

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

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

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