What are the problems associated with conducting clinical trials in India?
Issues like approval delays, deficiencies of functioning of CROs and other stake holders, liabilities and compensation to injured subjects, insurance issues etc still remain in India, which has made multinational companies to rethink on opting for India to conduct clinical trials in India recently.
Are clinical trials allowed in India?
Government regulation Since 2009 the Central Drugs Standard Control Organization has mandated that anyone conducting clinical research in India must preregister in the Clinical Trials Registry – India before enrolling any research participants. Various government agencies and laws regulate clinical trials.
What are the guidelines used in India for conducting clinical trials?
India follows ICH-GCP guidelines to conduct clinical trials which describes responsibilities of ethics committee, sponsor and investigator and the requirements of a protocol, the investigator’s brochure (IB) and documents to pass audits and inspection.
How much does a clinical trial cost in India?
For example, the application fees for a Phase III Clinical Trials have increased to INR 200,000 from INR 25,000. While previously there were no fees for a Phase IV study, the applicant must now pay INR 200,000 for a Phase IV study. There are also some new categories for which fees have been included.
Why is India a favorite place for pharmaceutical companies to conduct drug trials?
Large patient pool is one of the reasons that put India up as one of the most favorable destinations for clinical trials. India constitutes about 18% of total world population with one fifth of the global burden of disease. It records highest toll on maternal, neonatal and child deaths in the world.
What is GCP ICH?
ICH-GCP. The ICH-GCP is a harmonised standard that protects the rights, safety and welfare of human subjects, minimises human exposure to investigational products, improves quality of data, speeds up marketing of new drugs and decreases the cost to sponsors and to the public.
How much do Cros charge?
The mid-tier CRO agencies (good track record but with less experience in the field) will charge anywhere from $6,000 to $8,000 per month. The lowest-tier CRO agencies (starting out in CRO with less dedicated staff) will charge anywhere from $2,000 to $5,000 per month.
What is the law on clinical trials in India?
Further, the Medical Council of India Act, 1956 and the Central Council for Indian Medicine Act, 1970 also regulate the conduct of clinical trials in India. The Indian Council of Medical Research, the apex regulatory body for clinical trials, was set up to promote research culture in India and develop infrastructure for clinical trials.
What are the challenges faced by clinical trials in India?
Issues like approval delays, deficiencies of functioning of CROs and other stake holders, liabilities and compensation to injured subjects, insurance issues etc still remain in India, which has made multinational companies to rethink on opting for India to conduct clinical trials in India recently.
Are India’s Ich regulations complying with international clinical trials regulations?
In addition, India’s adoptions of ICH compliant regulations governing clinical trials further its constant endeavor to take its regulatory regime to global standards. Although regulations relating to clinical trials have evolved considerably to match global standards, many issues still remain.
Can clinical trials taking place in foreign countries be retested in India?
In 2005 an amendment was made in the Drug and Cosmetics Act. In consequence, clinical trials taking place in a foreign country need not be retested in India. It has entitled India to the result of global trials and availability of tested drugs.