Cdsco

Medtech backs India-NZ FTA, flags CDSCO exclusion as key regulatory gap

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

Centre revises DCGI recruitment rules, raises age limit to widen pool

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

Gujarat-based NGO seeks CDSCO oversight for nutraceuticals, flags concerns

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

Drug regulator may retain GMP relaxations in Schedule M for select products

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

CDSCO moves to fast-track foreign drug import approvals, cut delays

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

Firms with cancelled drug licences may face heat as Centre tightens rules

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

CDSCO asks states to maintain vigil on unlicensed IVF device sales

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

CDSCO flags 4 spurious drugs, 194 fail quality tests in February 2026

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

Companies eye alternatives after CDSCO bans weight-loss drug ads

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

Morning-after pills: DTAB pushes for boxed warnings, stricter norms

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

Delhi HC seeks response from Centre, CDSCO over misuse of diabetes drugs

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

CDSCO mandates online applications for manufacture, sale of r-DNA drugs

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

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 ...

Chemists warn PM that fake AI prescriptions are enabling illegal drug sales

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

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