News:The central government has decided to expand the reach of the Smart Safety Surveillance or 3S programme to optimize post-marketing surveillance of priority drugs and vaccines. Facts: About Smart Safety Surveillance(3S) Programme: The programme was introduced by the World Health Organization(WHO) in India considering limited safety data on vaccines in the country. The programme is… Continue reading To ensure post-marketing safety of vaccines, govt to expand the reach of 3S project
Tag: CDSCO
Explained: Under scanner, what is Ranitidine, and should Indian users worry?
News:Central Drugs Standard Control Organisation(CDSCO) has started looking into the concerns of potential cancer-causing substances contaminating popular acidity drug ranitidine. Facts: What is Ranitidine? Ranitidine is an over-the-counter prescription antacid used in the treatment of acid reflux and peptic ulcer diseases. It is commonly prescribed medicine for countering acidity and also on the World Health… Continue reading Explained: Under scanner, what is Ranitidine, and should Indian users worry?
New rules mooted on drugs dispensed by doctors
The Central Drugs Standard Control Organisation(CDSCO) has suggested amendments to the Drugs and Cosmetic Rules,1945 to ensure that registered medical practitioners dispense only generic medicines. A generic medicine is a copy of drug medication created to be the same as an already marketed brand-name drug.It is equal in dosage form, safety, strength, route of administration,… Continue reading New rules mooted on drugs dispensed by doctors
J&J offers to pay₹25 lakh each to 67 patients’ faulty hip implants
1. US pharmaceutical company Johnson & Johnson (J&J) Pvt Ltd has agreed to pay 25 lakhs to 67 patients affected by its faulty acetabular surface replacement (ASR) hip implants. Earlier,in May Delhi High Court directed it to pay ₹25 lakh each to 4 patients affected by its faulty hip implants. 2. Central Drugs Standard Control… Continue reading J&J offers to pay₹25 lakh each to 67 patients’ faulty hip implants
No patient complaints in India, says Medtronic
Medical device manufacturing company Medtronic has claimed that it had received no patient complaints in India after the US Food and Drug Administration (FDA) in its safety communication has alerted healthcare providers and patients about the batteries in certain Medtronic implantable pacemakers. US FDA had said that the pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps)… Continue reading No patient complaints in India, says Medtronic
CDSCO issues alert on pacemakers
The Central Drugs Standard Control Organisation(CDSCO) has issued an alert to healthcare providers, heart patients and medical device distributors on measures they have to take to prevent safety issues with three models of Medtronic’s pacemakers. This alert was issued after US Food and Drug Administration(FDA) in its safety communication had alerted healthcare providers and patients… Continue reading CDSCO issues alert on pacemakers
Drug advisory board proposes stringent norms for medical devices
Drugs Technical Advisory Board (DTAB) has recommended that the Centre should include all medical devices in the country under the Drugs and Cosmetics Act,1940 in a phased manner.Currently,the government regulates 27 notified medical devices under the law. Recommendations of DTAB to the Government are binding in nature.The Health Ministry will now be required to issue… Continue reading Drug advisory board proposes stringent norms for medical devices
CDSCO asks state drug regulators to ‘keep a strong vigil’ on buclizine sales
Central Drugs Standard Control Organisation (CDSCO) has issued an advisory to state drug regulators.It has asked them to keep monitoring on the manufacture,sale and distribution of buclizine.It is a brand of antihistamine and used as a motion sickness medicine. This advisory came after it was found that a government order prohibiting the sale of buclizine… Continue reading CDSCO asks state drug regulators to ‘keep a strong vigil’ on buclizine sales
No clinical trials in India for new drugs approved in select developed markets
Union Ministry of Health and Family Welfare has issued Drugs and Clinical Trials Rules,2019. The new rules say that new drugs approved for use in the EU,UK,Australia, Japan and the US will be automatically allowed in India provided clinical trials included Indian patients.The move is expected to reduce the time taken by pharma firms to… Continue reading No clinical trials in India for new drugs approved in select developed markets
Low conviction hinders fight against spurious drugs
According to the Drug Controller General of India(DGCI),conviction rates in the cases of spurious drugs is abysmally low.During 2015 to 2018,India has been able to convict only 35 cases of the 606 prosecutions launched against the manufacture,sale and distribution of spurious or adulterated drugs. Spurious or imitation drug products are formulations made to resemble another… Continue reading Low conviction hinders fight against spurious drugs
