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UNETHICAL CLINICAL TRIALS
Supreme Court orders Centre to respond to PIL on unethical clinical trials within four weeksThe Supreme Court has instructed the Centre to respond within four weeks to a PIL filed by Swasthya Adhikar Manch against unethical clinica...- Government to bar placebos in trials of new Covid jabsThe new protocol will have to be followed by vaccine makers like Gennova and others who are yet to start Phase III clinical trials of their...
- Experts likely to drop placebo arm from trials in policy shiftExperts are discussing whether administering a placebo to volunteers in a clinical trial is necessary in order to assess the safety and eff...
- Activists see red over easing of regulatory norms for clinical trialsThe health ministry notified that an investigator can handle as many clinical trials as approved by the Ethics Committee—a reversal from an...
- Easing clinical trial rules to compromise safety of subjects, say health activistsEthics committee, registered with DCGI according to the Drugs & Cosmetics Rules, can also decide whether a site is suitable for conducting ...
- EMA nod to publishing clinical trials data of okayed drugs a welcome moveFor all those who participate in clinical trials, it may come as a shock that the data about their trials may never be published.
- DCGI wants mandatory recording of clinical trial consentThe apex court had issued this directive so that any uninformed or false consent from patients enrolling into trials could be avoided.
- Digvijay demands probe into drug trials in poll-bound Madhya PradeshCongress leader Digvijay Singh today demanded a central government inquiry into drug-trial matter, claiming that more than 100 persons have...
- Supreme Court stays DCGI nod to 162 clinical trial applicationsDCGI had received 1,122 applications for clinical trials, of which the New Drug Committee approved 285 and the regulator cleared 162.
- Pharma companies adopt tough ethical normsAfter facing flak for illegal drug trials, and unethical marketing practices, the pharma industry seems to be pulling up its socks.
- Drug Regulator office has gone defunct as a quasi regulatory body takes charge of crucial approvalsDrug companies say that due to this committee, the DCGI has become non accountable to issues of drug approvals.
- PIL filed against illegal drug trialsSC today admitted a PIL regarding the alleged illegal clinical trials that were conducted on adults, children and mentally ill patients acr...
- In India, if there's element of doubt then you are seen as guilty: Dennis Gillings, CEO, Quintiles"We and our customers are nervous about the climate of clinical research in India, and we are not expanding and pausing to see how things g...
- No more off-the-record human clinical trialsThe government has mandated all human clinical trials being done in the country to be registered with the Indian Council of Medical Researc...
- FDA-approved inspectors plan short-notice audit of trialsUnder the scheme, a team of drug inspectors will walk into clinical trial centres at short notice and audit the internal processes and the ...
- Glenmark seeks action against govt hospital for falsifying dataGlenmark Pharmaceuticals has complained to the drug regulator that the government-funded research centre, Guru Govind Singh Hospital in Jam...
- Unethical clinical trials may invite painful penaltyGovt plans to amend the Drugs & Cosmetics Act to slap up to 10 years' imprisonment and cancellation of licence for violating norms for test...
- Government to crack whip on errant drug companiesThe government will soon amend its drug laws to give the health ministry explicit powers to punish companies that unethically test drugs un...
- Govt may make registration of clinical research cos mandatoryIn a move to step up vigil on clinical research, the government may make it mandatory to register clinical research organisations (CROs) an...
- CROs must play by the bookClinical research organisations (CROs) not adhering to best practices and ethics may now have to deal with stronger regulatory oversight.
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