The Drug Controller General of India (DCGI), along with the Central Drugs Standard Control Organization (CDSCO), is responsible for the approval of licenses of specialized categories of drugs in India, which include blood products, vaccines, IV fluids, and sera. It is the DCGI who lays down the standards and quality of manufacturing, selling, importing, and distributing drugs in India.
For a long time, India has been out of the list for sponsors to invest in conducting clinical trials in India because of lots of uncertainties and losses. But, the changes brought to the guidelines and standards of drug manufacturing, importing, and selling in India by the DCGI recently has helped India again gain momentum for clinical trials. Here are the recent updates by DCGI that have helped attract new clinical trials in the country.
1) Any new drug or new usage of any existing drugs will require approval from the DCGI. However, in case of any national emergency, extreme urgency, or for usage when diseases have no treatment therapy, the clinical trial for new drugs that have already gained approval in other countries can be waived.
2) Generics or biosimilars for other well-developed countries that have been marketed in those countries for more than 4 years and have a satisfactory report, will be approved for marketing in India after abbreviated trials.
3) Instead of a single New Drugs Advisory Committee (NDAC), the new drugs clinical trial approvals will primarily be reviewed by the Subject Expert Committee (SEC), after which their recommendations will be reviewed by the Technical Review Committee (TRC). Finally, the CDSCO will grant approval for the TRC recommendations. This system will ultimately decrease the turnaround time for clinical trial approvals.
4) All global clinical trials have been confirmed to have a deadline of 180 days for the turnaround time for approvals.
5) Primary care will be given to all trial subjects for any illness during their trial participation.
6) In case of any trial related injuries or death, the compensation should be paid to the trial subject or nominee, if any drug related anomaly has been identified and accepted.
7) For any Indians participating in global clinical trials prevalent in India, the sponsor or innovator must market the new chemical entity in an accelerated way by manufacturing, which needs to be confirmed in the form of undertaking while submitting the application.
8) Phase-I clinical trials will be exempted for medical devices, but the procedures for clinical trial approvals, accreditations of investigators, ethics committee, sites, and other conditions will remain the same.
9) The CDSCO will consider an existing therapy to compare the test drug, considering the placebo control, to ensure that it is efficient, ethical, and appropriate.
10) When a drug has been removed from the market by two or more countries, on grounds of safety and efficacy, the continued marketing of the drug in India will be subjected to examination and action.
11) A specialized cell within CDSCO will be working with the Indian Council of Medical Research (ICMR) for sponsoring various studies related to post-marketing surveillance of drugs, drug utilization, and adverse drug reactions.
With these new norms, it seems like India will rise higher to view more and more successful clinical trials in the future. To join this flourishing domain, you can also take up professional training in clinical research to take it up as a career. And, if you don't want to disturb your current job and responsibilities, but yet want to enter the sphere of clinical research, you can enroll yourself at Avigna Clinical Research Institute, the most professional clinical research virtual learning center Bangalore, where you can learn online from professionals, from the comfort of your home.