CDSCO

The drug regulator has directed manufacturers and distributors to supply IVF media and reagents only to registered ART clinics, strengthening oversight of assisted reproductive technologies

Draft amendments to the Medical Device Rules seek to reduce manufacturing licence timelines for Class B, C and D devices to improve regulatory efficiency and ease of doing business

The US drugmaker has launched Tanstrive, a RET-targeted oral therapy for advanced or metastatic solid tumours, following marketing authorisation from the CDSCO

Health Ministry prohibits 16 fixed drug combinations, including antibiotic and cosmetic formulations, after an expert review found they lacked therapeutic justification and posed potential health risk

Drug regulator alleges irregularities in reporting adverse events and conflict-of-interest disclosures by the unit's ethics committee during human clinical trials

Regulator seeks state-wise enforcement data as EU, US and Japan reject consignments linked to over 40 farms

The drug regulator has asked central and state authorities to verify compliance with pharmacovigilance requirements during routine inspections and regulatory reviews

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

The once-daily prescription tablet for type 2 diabetes received CDSCO approval after a Phase III trial showed comparable efficacy and safety to the innovator drug

CDSCO has directed states and UTs to curb surrogate advertising of GLP-1 obesity drugs amid rising sales and aggressive awareness campaigns

A risk-based system allows regulators to pay attention where it matters most, while providing industry with predictability

India's drug regulator has directed manufacturers and importers to submit Periodic Safety Update Reports (PSURs) for new drugs from the date of actual marketing of the product rather than from the date of regulatory approval, in a move aimed at strengthening post-marketing safety surveillance. In an advisory issued by the Central Drugs Standard Control Organisation (CDSCO) on April 21, the regulator said it has observed instances where companies obtained approval for a new drug but launched the product in the market much later while submitting PSUR data from the approval date instead of the launch date. The CDSCO said such a practice results in the loss of "valuable safety insights" that are critical for monitoring adverse effects and ensuring patient safety after commercial roll out of medicines. Under the Fifth Schedule of the New Drugs and Clinical Trials Rules, 2019, manufacturers and importers are required to submit PSURs as part of post-marketing drug safety monitoring. "In v

Medical device makers welcome India-NZ FTA for easing market access and exports, but flag absence of CDSCO in regulatory recognition framework as a key gap

The Centre has raised the age limit and broadened eligibility norms for appointing the Drug Controller General of India to address a shortage of qualified candidates

A Gujarat-based NGO has urged the government to bring nutraceuticals, including fortified foods and health supplements, under the ambit of drug regulators by implementing the recommendations of a 2024 inter-ministerial committee, citing concerns over product quality and unregulated pricing. In a representation to Union Health Minister JP Nadda, the organisation 'Right to Life' said the current regulatory framework, which classifies nutraceuticals as food products under the Food Safety and Standards Authority of India (FSSAI), has led to a "serious dilution" of manufacturing standards and oversight. The NGO argued that many nutraceuticals are routinely prescribed by doctors across specialties such as cardiology, orthopaedics and gynaecology as adjunct therapeutic interventions, and are dispensed through pharmacies in a manner similar to prescription drugs. "Patients have a reasonable expectation that such products meet pharmaceutical-grade quality and safety standards. However, their

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