Sunday, 21 August 2016

clinical trial requirements in India is streamlined, CDSCO, clinical trials, India

clinical trial requirements in India is Streamlined


Effective 2nd August 2016, the Central Drugs Standard Control Organization (CDSCO) India released new circulars in relation to the conduct of clinical trials. These new circulars have modified the trial requirements for sponsors wishing to conduct clinical trials in India. Furthermore, the CDSCO have addressed matters that may assist in reducing clinical trial timelines and encourage further investigator participation.
These changes are as follows:
Requirement of No Objection Certificate (NOC) from DCGI (Drug Controller General India) for addition of new Clinical Trial site or investigator
It was decided that the respective ethics committee, after due diligence, can approve proposals for addition of site(s) and investigator(s) and that a NOC from DCGI should not be necessary. However, the applicant would need to inform the DCGI regarding any addition/deletion of sites and investigators. Subsequently, if no objection was received from the DCGI, it would be considered admissible by the CDSCO.

Restriction of conducting three clinical trials per investigator
The impact on sponsors being unable to utilise sites/PIs (principal investigator) with specific patient populations (as a result of earlier restrictions) has now been addressed as a result of this circular. Prior to this no investigator could conduct more than three trials at any time. Once an ethics committee examines the risk and complexity involved in the proposed trial(s), they will then decide how many trials an investigator is permitted to undertake.
Requirement of 50 bedded site for clinical trials
Previously it was determined that no clinical trial shall be conducted at sites with less than 50 hospital beds. This position has been revised and it has now been established that an ethics committee will examine the trial requirements and decide whether the intended clinical trial site is suitable (or not), irrespective of the number of beds. Additionally, it was noted that sites will need to have appropriate emergency rescue and care services, along with all other necessary facilities required for a particular trial.
Requirement of approval of Review Committee on Genetic Manipulation (RCGM) under Department of Biotechnology for r-DNA derived drugs

Going forward, the applicant may submit parallel applications to the RCGM and DCGI seeking approval to conduct a clinical trial involving r-DNA derived drugs. DCGI will complete the review of the application and issue permission, only after RCGM clearance is received.
With these new requirements in place, processes such as assigning new sites/investigators to a study; facilitating the conduct of out-patient based studies at small hospitals/clinics that have larger patient pools; allowing motivated, research-focused investigators to undertake more trials at appropriate sites and, potentially reducing clinical trial approval timelines for rDNA based products, will help to streamline clinical trial set up and ongoing operations for sponsors.
Partnering with a CRO that has experienced, regulatory professionals both central and in-country can provide efficiencies when conducting trial in countries with unfamiliar or shifting regulations. George Clinical’s regulatory team possess a wealth of experience, region knowledge and contacts needed to communicate effectively with the appropriate, in-country regulatory agencies – such as DCGI and CDSCO. This allows us to anticipate and resolve any potential issues or hurdles that may arise throughout your trial. As such, we can provide the relevant advice and strategies tailored to your individual needs, based on the most current regional guidelines, as part of the global regulatory context. With these qualities, we are able to provide customizable trial excellence from trial design through all aspects of delivery.

Key Points:
  • New regulations will help streamline trial requirements for new/current clinical trials in India.
  • George Clinical’s regulatory team will analyse potential impact of any regulatory changes and provide expert advice on applicability and integration; ensuring your regulatory requirements are met.
  • Recommended that sponsors partner with experienced CROs with in-depth knowledge of India’s regulatory environment.
For more information on these circulars or the CDSCO, please visit: http://www.cdsco.nic.in/forms/list.aspx?lid=1604&Id=31
For more information on ICBio Clinical Research  and our services, please visit:www.icbiocro.com,  CDSCO, clinical trials, India

or write to us on info@icbiocro.com 

Wednesday, 22 June 2016

Now ICBio adds BA BE facility in its operations, approved by CDSCO,

Now ICBio adds  BA BE facility in its operations, approved by CDSCO, www.icbiocro.com

ICBio CRO is one of the leading Contract Research Organization in Asia, based in Bangalore, INDIA, offering End to End Research Services / Functional Service Providers (FSP) to the Global Pharmaceuticals and Cosmetics Industries,conducting clinical trials in India and the Emerging Markets across globe.
ICBio has a well-designed, custom-built, compliant Facility to conduct various activities of Clinical Research. It is spread over a total floor area of 20,000 sq.ft, includes Clinical Units, Bio analytical Laboratory, Volunteer screening, Volunteer Information centers and external archives.
Our team leading various departments has a several years of experience in the Pharmaceutical Companies and CROs together. With the help of this expertise, we offer our services in Phase II, III Clinical trials, medical writing services and Bioavailability / Bioequivalence studies in Healthy volunteers as well as Patients.
ICBio has vast expertise in clinical trial and project management, having conducted complex clinical development programs of biologics, small molecules, and completed them within the time. We have a long track record of evaluating the safety and efficacy for a wide range of therapeutic indications, our expertise lies in diabetes and metabolic disorders with the support of its pan India network of Investigators and sites.
We are Client focused, flexible and also cost effective CRO in India, we focus on quality and add value services to our clients', we strictly adhere to timely execution of clinical projects within budget and accurate, reliable and comprehensive data by following ICH-GCP guidelines.
ICBio served a diverse customer base of more than 30 satisfied customers. We have consistently exceeded our customers' expectations in terms of quality, speed and affordability.
ICBio is an ISO 9001: 2008 certified company and has been inspected and approved by MOH, Kazakhstan,

Thursday, 25 February 2016

Do we need More compensation for Clinical Trials or stop the growing CRO industry?

Do we need More compensation for Clinical Trials or stop the growing CRO industry?

 “The number of trials has reduced considerably because of the Supreme Court’s intervention. Also there is greater compensation,” according to me “Patients will now get at least four times more than they would have got before.”
The health ministry is currently working on a clinical-trial policy that will incorporate quicker approvals and balanced compensation guidelines. “The baseline figure of 800,000 rupees (US$13,000) as per the formula can result in actual compensation of 400,000 rupees (US$6,500) for patients over 65 years old with a short period of expected survival and a maximum of 7.29 million rupees (US$0.1m) for young volunteers in phase 1 trials. Earlier, the compensation was 50,000 rupees (US$800) with a maximum of 300,000 rupees (US$5,000),” he says.
However, determining the cause of death is dependent on the integrity of the investigator: “There are over 30,000 investigators in India — how many are honest and how many are corrupt?” No sponsor would like to publicise unfavourable results, according to me, and there is a conflict of interest because investigators are employees of the sponsor and would find it difficult to file an adverse report. “There is no independent mechanism,” .
Pulling out
Given the uncertain regime, drug companies and CROs are cutting back on clinical trials in India. The Indian Pharmaceutical Alliance (IPA), which represents leading domestic pharmaceutical companies, says that the increasing reluctance of India’s drugs and devices regulator to grant approvals for new drugs, even if they are approved in developed countries, and to allow clinical trials or biostudies for export purposes, has severely hampered the industry.
The hub appears to have shifted to China, where a lot of government support has come to the aid of the industry, in terms of easier processes
Francis says that some trials have moved to other countries. “The hub appears to have shifted to China, where a lot of government support has come to the aid of the industry, in terms of easier processes. English has also been made mandatory in China, which has given a fillip to most CROs to take on work from multinationals.”
it is easier to conduct business outside India. “CROs in Turkey, Indonesia and Malaysia are flourishing, since the regulatory norms are not so strict and approvals are given faster,” adding that CROs in Eastern Europe have made it cheaper to carry out clinical trials there.
“From 2010–2011, things have changed quite drastically for CROs. These regions [Eastern Europe] used to charge heavily, so many of the multinational companies moved to India, where it was 40% cheaper to conduct trials and there was a ready demographic,” she explains. “Now, the margin has come down considerably.”
The effects of the regulatory uncertainty are already being felt. Max India, for example, has announced that it will sell its clinical research business for US$1.5m to JSS Medical Research, a Canadian CRO. The company says the regulatory challenges have made it difficult to scale up the business.
Other Indian pharmaceutical companies, such as Biocon, Alembic, Zydus Cadila, Torrent and Lupin, have already moved trials out of the country. At Biocon, the research and development (R&D) spend is 134% higher in the second quarter of 2015 compared with the same period in 2014. The company’s chairman, Kiran Mazumdar-Shaw, said at an analyst briefing that the high R&D spend is a result of ongoing global clinical trials that require large investment. For example, Biocon’s global phase III trial for biosimilar trastuzumab is being conducted in Europe.

Indian CROs, started moving out to other Asian countries, including Malaysia and Thailand, Since there is a high degree of uncertainty in India has discouraged clinical trials.