Skip to main content

Registration of BA/BE studies with CTRI to become mandatory soon


After more than two years since the registration of clinical trials was made mandatory in the country, the Union health ministry will soon make the registration of bioavailability and bioequivalance (BA/BE) studies mandatory with the Clinical Trial Registry of India (CTRI).

According to sources, the Union health ministry has already taken the decision in-principle to make the registration of BA/BE studies mandatory, on the same lines of the other clinical trials in the country. The drugs controller general of India (DCGI) Dr Surinder Singh has already directed the senior officials in the CTRI to make the necessary changes in its web network to incorporate the BA/BE features, sources said.

According to sources, just like the clinical trials, the DCGI wanted to streamline the BA/BE studies in the country. So far, registration of BA/BE studies with the CTRI was optional. Once the DCGI makes it mandatory, all the BA/BE studies have to be registered with the CRTI without which the DCGI will not give permission to conduct BA/BE studies which are conducted on healthy volunteers.



Hundreds of BA/BE studies are going on at any given time in the country at different clinical research centres. BA/BE studies which take about three months time, are conducted for finding the bioavailability and bioequivalance of a drug, especially the generic drugs and the combination drugs which are already in the market. For getting the license for a new combination drug or generic drug, it is mandatory to submit the BA/BE study results to the DCGI office.

The CTRI was set up by the National Institute of Medical Statistics (NIMS) which is an arm of Indian Council of Medical Research (ICMR) and is funded by the Department of Science and Technology (DST) through ICMR. It also receives financial and technical support through the WHO, WHO-SEARO, and the WHO India Country office.

The main objective of the CTRI is to ensure that every clinical trial conducted in the region is prospectively registered with full disclosure of the 20-item WHO ICTRP dataset, as well all items of the CTRI dataset, in order to improve transparency and accountability; improve the internal validity (details of the methods of the trial that produce reliable results, primarily the method of random sequence generation, concealment of allocation, blinding of participants and investigators, and inclusion of all participants results) of trials right from the design,through conduct and reporting; conform to accepted ethical standards; and lead to reporting of all relevant results of all clinical trials in India and the region.

Labels:

Comments

Post a Comment

Popular posts from this blog

Registration of herbal trials in CTRI is not mandatory

A trial patient visited the site complaining breathlessness and tachycardia. The investigator advised hospitalization but as subject could not afford the expenses, he refused for admission. Is this an SAE because investigator advised hospitalization? G Praveen Kumar. If the patient was not hospitalized, it does not fall into SAE criteria of hospitalization. However, it appears from your mail that the PI felt that the event was serious enough to admit the subject for treatment. This makes it an “important medical event." As per ICH E2A such event also are considered serious. See the ICH E2A excerpt below: Medical and scientific judgement should be exercised in deciding whether expedited reporting is appropriate in other situations, such as important medical events that may not be immediately life-threatening or result in death or hospitalisation but may jeopardise the patient or may require intervention to prevent one of the other outcomes listed in the defin...
Post a Comment
Read more

Evidence for Atypical Antipsychotic Drugs Called into Question

Despite massive advertising and booming prescriptions, use and sales, the new atypical antipsychotic medications such as Seroquel and Abilify – used to treat schizophrenia , bipolar disorder, depression and other illnesses – lack sufficient evidence to support their widespread and generalized usage. This according to a new study out of the Stanford University School of Medicine and University of Chicago. In the past decade, atypical antipsychotics have rocketed past many commonly prescribed, but older antidepressant and other psychiatric medications. Although initially touted as having few side effects, followup studies have found that atypical antipsychotics have serious side effects, including significant weight gain that can lead to diabetes and heart disease. “Because these drugs have safety issues, physicians should prescribe them only when they are sure patients will get substantial benefits,” said Randall Stafford, M.D., Ph.D., a Stanford associate pro...
Post a Comment
Read more

Unani medicine research institute to come up in Faridabad

A national research institute of 'Unani' medicine will be set up at a village in Faridabad district, a spokesman of Haryana government said today. The institute, which will provide healthcare facilities in the field of non-communicable diseases, would also include a 120-bedded in-patient department, the spokesman of the Ayush department said. Chief Minister Manohar Lal Khattar has approved a proposal to allot land of Kheri Gujran village for the institute. The institute would be developed as a state-of-the-art research centre with facilities for pre-clinical studies, clinical trials, drug standardisation and cultivation of medicinal plants used in 'Unani' system, the spokesman said. It would also offer facilities such as research and geriatric OPDs, speciality clinics, he said. The institute would have laboratories for bio-chemistry, pathology, radiology and USG, drug standardisation, immunology, pharmacognocy and phytochemistry, besides regimental therapy unit, library...
Post a Comment
Read more