The Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health and Family Welfare, Government of India, is the National Regulatory Authority of India for giving the final approval of clinical trials to be conducted in India and approval of new drug to be marketed in India. However, in some cases depending upon the nature of drug, an additional approval or recommendation from other Department / Ministries / Laboratories is also required. These are:
- RCGM: Review Committee on Genetic Manipulation, Department of Biotechnology, Ministry of Science and Technology.
- GEAC: Genetic Engineering Approval Committee, Ministry of Environment and Forests.
- NAC-SCRT: National Apex Committee for Stem Cell Research and Therapy, Department of Health Research, Ministry of Health and Family Welfare.
- CDL: Central Drugs Testing Laboratories, in Kasauli and Kolkata.
- AERB: Atomic Energy Regulatory Board, under DAE, directly under the Prime Minister’s Office.
- DGFT: Directorate General of Foreign Trade, Ministry of Commerce and Industry.
- HMSC: Health Ministry’s Screening Committee
RCGM is the Review Committee on Genetic Manipulation (RCGM) of the Department of Biotechnology). It has been formed as a part of a three tier mechanism in order to: a) grant approvals to various R&D Projects on recombinant DNA products, b) monitor and evaluate research activities involving recombinant DNA technology and c) evaluation of pre-clinical study reports and recommendations to DCGI for appropriate phase of clinical trials of similar biologics or rDNA products.
The meeting schedule of the committee is generally published on the Department of Biotechnology website, which can be accessed here.
The applicants are required to submit 4 hard copies and one soft copy (in a compact disc) of their application, in a suggestive format. It is advisable that these applications are sent at least 45 days before the RCGM meetings have been scheduled, for their consideration.
GEAC is the Genetic Engineering Approval Committee under the Ministry of Environment and Forests.This committee is largely responsible for the appraisal of activities that involve large scale use of hazardous microorganisms and recombinants in research and industrial production, from the environmental angle. The committee also appraises proposals related to the release of genetically engineered organisms and products into the environment including experimental field trials.
GEAC approval is required for the following activities (in addition to other approvals):
- Import, export, manufacture, transportation, sale of microorganisms or genetically engineered substances or cells, including products that have been derived by Gene Therapy.
- Production of genetically engineered microorganisms in industrial production or application.
- Discharge of genetically engineered microorganisms from the laboratory or hospital into the environment
The committee (or person authorised) acts according to the Environment Protection Act 1986, amended in 1991.The committee comprises of experts from ICMR, DBT, Director General of Health Services, and others.
The GEAC generally meets on the second Wednesday of every month to consider various applications and policy issues. The agenda and dates of the GEAC meetings can be accessed here.
The various forms for applying to GEAC can be accessed here.
NAC-SCRT is the National Apex Committee for Stem Cell Research and Therapy of the Department of Health Research, Ministry of Health and Family Welfare. This committee supervises all activities in the field of stem cell research and therapy in India, via an examination of its scientific, technical, legal, ethical and social issues.
It is important to note that, as per the National Guidelines for Stem Cell Research, 2017, all institutes involved in research on human stem cells must constitute an Institutional Committee for Stem Cell Research (IC-SCR) and register with the NAC-SCRT. This registration and compliance with the guidelines is mandatory. The application form and formats for registration of IC-SCR are available here. All registered IC-SCRs are also required to send annual reports to the committee in the prescribed format.
According to the National Guidelines for Stem Cell Research, 2017, there are no approved indications for stem cell therapy other than for Haematopoietic Stem Cell Transplantation (HSTC) for haematological disorders. Accordingly, all stem cell therapies other than HSTC, shall be treated as investigational and may be conducted only in the form of clinical trials after obtaining the necessary regulatory approvals. Use of stem cells for any other purpose outside the domain of clinical trials will be considered unethical, and therefore is not permissible.
Monitoring Stem Cell Research in India:
Two levels of monitoring mechanisms have been established:
- National: The NAC-SCRT monitor stem cell research at the national level, via policy, guidelines. The committee comprises of an independent body of experts that represent diverse areas of biomedical research, stakeholders and related government agencies.
- Institutional: The IC-SCRs operate at the institutional level and comprise of members with expertise as specified by the guidelines developed by NAC-SCRT. IC-SCR must be registered with the NAC-SCRT.
Annexure 1 of the National Guidelines for Stem Cell Research, 2017 gives a detailed breakdown of the composition and functioning of both NAC-SCRT and IC-SCRs.
Cell Biology Based Therapeutic Drugs Evaluation Committee (CBBTDEC), is a core panel of experts, constituted to assist and advice DCGI on matters pertaining to the approval of clinical trials and market authorization for Therapeutic products derived from Stem Cell, Human Gene manipulation and Xenotransplant Technology. The CBBTDEC generally conducts an in-depth evaluation of all technical documents furnished to the DCGI and accordingly makes recommendations for rejection or approval of the application.
The Central Drugs Laboratoryat Central Research Institute, Kasauli (CDL) is the national central laboratory for testing of immunobiologicals (both vaccines and antisera) meant for human use in India. The laboratory has been established as per the provisions of Drugs and Cosmetics Act 1940 and Rules 1945.
The lab has the mandate of national regulation of vaccines produced indigenously for the domestic market, immunization programme of Government of India. The drugs or classes of drugs that CDL, Kasauli tests are: sera, solution of serum proteins intended for injection, vaccines, toxins, antigens, anti-toxins, sterilized surgical ligature and sterilized surgical suture; bacteriophages, including Oral Polio Vaccine. The detailed functions of the lab can be accessed here.
There are others institutes and laboratories that have been identified in the Drugs and Cosmetics Act, for evaluation and testing of drugs used for veterinarian purposes, intra-uterine devices, homeopathic medicines, etc. For a complete list of these centres please refer to the Drugs and Cosmetics Act and Rules, 1945, as amended up to the 30th of June 2005, here. Some of these are:
Central Drug Laboratory (CDL), Kolkata
Central Drug Laboratory at Kolkata is responsible for the following:
- Analytical quality control of majority of imported drugs that are available in the Indian market.
- Analytical quality control of drug and cosmetics manufactured within the country (on behalf of the Central and State Drug Controller).
- Acting as an appellate body in matters of dispute regarding the quality of a drug.
CDL, Kolkata is one of the national laboratories identified by CDSCO for quality control and analysis. Other functions carried out by CDL, Kolkata can accessed here.
Central Drugs Testing Laboratory (CDTL), Mumbai
Central Drugs Testing Laboratory (CDTL) in Mumbai is one of the national statutory laboratories, set up by the Government of India. It functions under the control of Drugs Controller General India. One of the key functions of the laboratory includes the testing and analysis of drugs and cosmetics manufactured in the country. More information on CDTLcan be accessed here.
There are 7 similar CDTL / RDTL laboratories established in India, in different geographical zones.
Bhabha Atomic Research Centre (BARC) is the agency that regulates radioactive materials in India. If a trial involves a drug which is a radioactive material, then like all other clinical trials involving INDs, regulatory permission will be sought from the Central Drugs Standard Control Organization (CDSCO) and ethical approval from the institutional ethics committee. However, if the trial involved the evaluation of a radioactive material as a diagnostic agent then the following will also be applicable:
- The permissible limit of radiation must comply with the guidelines that have been issued by the Atomic Energy Regulatory Board (AERB).
- The investigating site (for the trial) must have a license from the competent authority to handle, store and dispense radioactive substances. The e-Licensing of Radiation Application (eLORA) System has issued guidelines to help with the application process. More information about AERB’s licensing process can be accessed here.
- The Atomic Energy (Radiation Protection) Rules, 2004 can be accessed here.
- More information about Diagnostic Radiology issued by the AERB can be accessed here.
- Bhabha Atomic Research Centre (BARC) is the agency that regulates radioactive materials in India.
The Directorate General of Foreign Trade (DGFT) is an organisation attached with the Ministry of Commerce and Industry which is involved in the regulation and promotion of foreign trade through regulation.
In the context of clinical trials and research, in the past, laboratories or research institutions wanting to import or export biological samples outside of India, required a license to do so. This license was issued by the DGFT. However according to a notification published in August 2016 by the Ministry of Commerce and Industry, currently, to import or export human biological samples by an Indian diagnostic laboratory or clinical research centre, the customs authorities at the port of entry or exit must permit it. The laboratory or research centre carrying out the import or export does not require a license from a Government agency. However, an undertaking needs to be furnished that all applicable regulations, rules and procedures for the safe transfer and disposal of the biological samples being exported or imported will be followed. This undertaking must be furnished to the Customs Authorities at the port of entry or exit along with the details of the samples.
The above cited gazette also covers the export of SCOMET (which is Special Chemicals, Organisms, Materials, Equipment and Technologies). The list of items covered under SCOMET are available on the DGFT website.
Further reading and useful links:
- Laboratory biosafety manual, published by the World Health Organisation in 2004, can be accessed here.
- Guidance on Regulations for the Transport of Infectious Substances published by World Health Organisation, can be accessed here.
- The ITC(HS) Schedule 2 Export Policy (2018) can be accessed here.
- The Import Policy (2017) can be accessed here.
The Health Ministry’s Screening Committee (HMSC)is a high level committee that was constituted by the Government of India in the 1980s to screen and approve international collaborative proposals in the field of biomedical health research. Itconsists of members from various departments to form a pool of expert reviewers.
The International Health Division within the Indian Council of Medical Research (ICMR) acts as the secretariat for HMSC and facilitates the technical review of proposals that are submitted.
The Indian collaborator of the research project is expected to submit the necessary documents and protocol (as required) to ICMR for consideration. Proposals that are submitted to HMSC should be in the prescribed format of the funding agency or the organization. If there is no particular format, the proposal can be drafted as per ICMRs format.
There is some information available for scientists on how to develop Indo-foreign collaborative proposals for research in biomedical sciences.
Further reading and resources:
- Guidelines for International Collaboration / Research projects in Health Care
- ICMRs portal for submission of project proposals to HMSC
- ICMRs checklist for HMSC consideration
- Documents required for HMSC consideration