Page 2 - Cdsco

India approves Eli Lilly's Mounjaro pen for diabetes, weight control

Eli Lilly's once-weekly KwikPen format for Mounjaro has been approved in India, offering an easier delivery system for type 2 diabetes and chronic weight management

CDSCO relaxes loan license requirement for med device sterilisation

Medical device makers can now outsource sterilisation through third-party agreements without loan licences if the facility holds a valid sterilisation licence

CDSCO lists 17 drugs safe to flush to prevent harm from misuse at home

Regulator's draft guidance allows flushing of 17 high-risk drugs including opioids; calls for drug take-back sites to curb AMR, environmental and public health risks

AstraZeneca Pharma rises 2% on securing CDSCO nod for Benralizumab solution

AstraZeneca Pharma shares rose on receiving nod from the CDSCO, to import for sale and distribution of Benralizumab 30 mg/ml solution for injection (brand name: Fasenra) for an additional indication.

Hypertension, anti allergy meds among 196 drugs flagged by CDSCO as NSQ

Monthly CDSCO alert identifies 196 batches of drugs as not of standard quality and flags one Deca-Durabolin injection as spurious and under investigation

CDSCO revises export NOC rules for new drugs; sets one-year validity

New CDSCO rules set one-year validity for export NOCs, fix seven-day timeline, and simplify process for unapproved and approved drugs meant solely for export

CDSCO flags spurious batch of Telma, 131 other drugs fail quality tests

One of the popular hypertension medication brands Telma 40 samples were found to be spurious in raids across locations

CDSCO halts manufacture, sale, distribution of 35 FDCs over safety concerns

The list of unapproved FDCs includes antidiabetics, antibiotics, painkillers, infertility medications and nutritional supplements

Govt bans manufacture, sale of 35 unapproved fixed-dose combination drugs

Apex drugs regulatory body CDSCO has directed drug controllers of all states and Union territories to stop manufacture, sale and distribution of unapproved 35 fixed-dose combination drugs that include painkillers, nutrition supplements and anti-diabetics. They have also been asked to review their approval process for such fixed dose combination drugs (FDC) and ensure strict compliance of the provisions of the Drugs and Cosmetics Act 1940 and rules. FDC drugs are those which contain a combination of two or more active pharmaceutical ingredients (APIs) in a fixed ratio. The regulator issued the directions after it found that certain FDC drugs have been licensed for manufacture, sale, and distribution without prior evaluation of safety and efficacy, posing a serious risk to public health and safety. In a communication sent on April 11, Drugs Controller General of India (DCGI) Dr Rajeev Raghuvanshi referred to the letter issued by his office on January 2013 where concerns were raise

CDSCO brings new rules for drugs transfer from SEZ units to domestic mkt

In a circular dated April 8, the CDSCO mandated a new procedure to streamline the transfer of drugs manufactured in SEZs to DTAs for sale and distribution

CDSCO issues revised risk classification list for cardiovascular devices

Industry stakeholders asked to submit feedback to draft list by April 30

Spurious batch of Telma H flagged, 103 other drugs fail CDSCO tests

Telma H is manufactured by Glenmark Pharmaceuticals and is prescribed for controlling high blood pressure, particularly in individuals prone to water retention or heart failure

Booster shot: Mounjaro may emerge as a sweet pill for Eli Lilly in India

Analysts say the diabetes and obesity drug can be a Rs 500 crore opportunity for the firm

Alkem Laboratories eyes bigger pie of diabetes, weightloss market

Semaglutide, an active ingredient in drugs like Ozempic and Wegovy, is owned and produced by Novo Nordisk and is set to go off-patent in India in March 2026

Licensing delays pushing medical device makers abroad: Parliament panel

Implementation of tracking system, independent advisory board, lateral entry among panel's recommendations to remove CDSCO's perception of licence raj

CDSCO flags select batches of 145 drugs for failing quality standards

Fifty-two drugs were identified by central drug laboratories, while another 93 were flagged by state drug testing labs

CDSCO centralises GMP issuance and verification with new online portal

This initiative addresses long-standing concerns over inconsistent certificate formats and verification challenges across India's 28 states

Vaccine makers can add clinical trial sites through Sugam, says CDSCO

The recent notice brings applications for biological products such as vaccines and recombinant deoxyribonucleic acid (rDNA)-based drugs under the online ambit

CDSCO plans to streamline drug export clearances to reduce workload

The agency has only 2,000 officials to oversee over 10,000 drug factories and 1 million pharmacies in India

CDSCO withdraws export NOC, bans drugs linked to West Africa opioid crisis

The ministry added that Aveo Pharmaceuticals has been issued a Stop Activity Order, halting all operations at the company's premises after a comprehensive audit