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Current Regulatory Scenario for Conducting Clinical Trials in India

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Volume 4 • Issue 2 • 1000140
Pharmaceut Reg Affairs
ISSN: 2167-7689 PROA, an open access journal
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ISSN: 2167-7689
Ramu et al., Pharmaceut Reg Affairs 2015, 4:2
http://dx.doi.org/10.4172/2167-7689.1000140
Review Article Open Access
Pharmaceutical Regulatory Affairs: Open Access
Current Regulatory Scenario for Conducting Clinical Trials in India
Ramu B1*, Sathish Kumar M2 and Ramakrishna M3
1Department of Pharmaceutics, K.V.K. College of Pharmacy JNTUH, Hyderabad, India
2Department of Analysis, K.V.K. College of Pharmacy, India
3Department of Pharmaceutics, Avanthi Institute of Pharmaceutical Sciences, India
Introduction
India with well trained skilled professionals and vast Pharma
companies oers unique opportunities for conducting clinical trials.
Due to signicant cost reduction and increased pace and productivity
of all R&D phases has brought considerable growth and impact to the
favorable regulatory climate for conducting the clinical trials in India.
Various institutions playing a prominent role in guiding the clinical
trial in India include DCGI (drugs controller general of India), DBT
(department of biotechnology), ICMR (Indian council of medical
research, CBN (central bureau of narcotics), RCGM (review committee
on generic manipulation) GEAC (genetic engineering approval
committee) [1,2].
Current Drug Regulatory Procedures
Currently the clinical trials are regulated by schedule Y of the drug
& cosmetics rules, 1945.Aer the amendment of the D&C act in 2005,
the schedule Y was extensively revised to bring the Indian regulations
up to par with internationally accepted denitions and procedures. e
changes which took place were
• Denitions for Phase I-IV trials, which eliminated the Phase
lag.
• Clear responsibilities for investigators; and sponsors.
• Requirements for notifying changes in protocol.
e Central Drugs Standard Control Organization (CDSCO) under
Ministry of Health and Family Welfare (MoH and FW) prescribes
standards for ensuring safety, ecacy and quality of drugs, cosmetics,
diagnostics and devices in India. Apart from these there are other
Statutes and ministries that regulate the various aspects of drugs such
as; the Poisons Act, 1919; the Pharmacy Act, 1948; the Drug and Magic
Remedies (Objectionable Advertisement) Act, 1954;the Narcotic Drugs
and Psychotropic Substances Act, 1985; the Insecticide Act, 1968; e
Medicinal and Toilet preparation (Excise duties) Act, 1956 and e
Drug (Price Control) Order, 1995 (under the essential commodities
Act).Some more laws having a bearing on pharmaceutical manufacture,
distribution and sale in India are e Industries (Development and
Regulation) Act, 1951,e Trade and Merchandise Marks Act, 1958,
e Indian Patent Act, 1970 and the Design Act, 2000 and the Factories
Act, 1948 [3-7].
Clinical trials have been dened in Rule 122DAA of the Drugs &
Cosmetics Act (D&C Act) in India as “Systemic study of new drugs
in human subject(s) to generate data for discovery and/or verifying
the clinical, pharmacological (including pharmacodynamics and
pharmacokinetics) and/or adverse eects with the aim of determining
safety and/or ecacy of the new drugs.
For new drug substances discovered in India, clinical trials are
required to be carried out in India right from Phase I and data should
be submitted as per the requirement. However for the for new drug
substances discovered in countries other than India, Phase I data will be
required from the other country and should be submitted along with the
application. Aer submission of Phase I data generated outside India to
*Corresponding author: Ramu B, Department of pharmaceutics, K.V.K college of
pharmacy JNTUH, Hyderabad, India, E-mail: bandameedi.ramu@gmail.com
Received April 25, 2015; Accepted May 19, 2015; Published May 26, 2015
Citation: Ramu B, Sathish Kumar M, Ramakrishna M (2015) Current
Regulatory Scenario for Conducting Clinical Trials in India 4: 137. doi:
10.4172/2167-7689.1000140
Copyright: © 2015 Ramu B. This is an open-access article distributed under the
terms of the Creative Commons Attribution License, which permits unrestricted
use, distribution, and reproduction in any medium, provided the original author and
source are credited.
the Licensing Authority, permission may be granted to repeat Phase I
trials and/or to conduct Phase II trials and subsequently Phase III trials
concurrently with Page 3 of 5 other global trials for that drug. Phase
III trials are required to be conducted in India before permission to
market the drug in India is granted. Application for permission to start
specic phase of clinical trial sponsor is required to submit application
(Form 44) for the purpose of conducting clinical trial in India and
submit documents as per Schedule Y of the Drugs and Cosmetics Act
1940 and Rules. A clinical trial application utilizes Form 44 [3] as given
in table-01, accompanied by documents pertaining to chemical and
pharmaceutical information, animal pharmacology, toxicology data
and clinical pharmacology data. Other trial-related documents that
must be submitted for approval include the Investigator’s Brochure,
trial protocol, case report form, informed consent form, investigator’s
undertaking. In addition, the trial’s regulatory status of the trial in other
countries must be reported. e clinical protocol must be reviewed and
approved by an IEC of all participating sites. e requirements in respect
of Chemistry and Pharmaceutical information has been elaborated
separately for Biologicals while other requirement for conduction of
Clinical trial and other requirements remains the same as per Schedule
Y of Drugs and Cosmetic Rules 1945 (Table 1).
e checklist has been published by the CDSCO oce for the
conduct of phase I/II/II clinical trial as given in table-02 [5,6]. e
anticipated timeline for the approval of conduct of the study is around
8- 12 weeks if direct approval is granted. But if it is a new drug/First in
human trials the applications are referred to the IND committee which
would take anywhere from 12-24 weeks to give their opinion. Based
on this opinion the DCGI oce may approve (with or without some
changes to the protocol) or seek clarications or decline approval 3
(Table 2).
Conclusion
Clinical trials are the key tools in new drug evaluation. India has
signed the trade related intellectual property rights (TRIPS) agreement
as a part of the WTO regulations to gearing up to attract more and
more researchers from around the world to conduct clinical trails in
India. Recent amendments in the regulatory requirements have shied
the thrust from just safeguarding the subjects to providing them for
access for biomedical innovation. India is poised to oer the global
pharmaceutical industry high quality & cost eective contract services
to support drug discovery.
Volume 4 • Issue 2 • 1000140
Pharmaceut Reg Affairs
ISSN: 2167-7689 PROA, an open access journal
Citation: Ramu B, Sathish Kumar M, Ramakrishna M (2015) Current Regulatory Scenario for Conducting Clinical Trials in India 4: 137. doi:
10.4172/2167-7689.1000140
Page 2 of 3
Table 2 Checklist for Permission For Conducting Clinical Trial (Phase I, II, III) And Global Clinical Trial For Biological Application
Name of the Applicant
Drug
Dosage form, Composition and packing details
Form 44
TR Challan
Sponsor’s name and Authorization letter
Chemical and Pharmaceutical/CMC information
Pre-clinical data
Animal Pharmacological data as per Appendix IV to Schedule Y
Animal Toxicological data as per Appendix III to Schedule Y
Study Protocol
Protocol Number
Phase of the study
Study Rationale
Undertaking by investigators as per Appendix VII to Schedule Y
Name and No. of Centre’s and Investigator’s
No. of patient to be enrolled Globally
India
Name/Numbers of countries participating in study
Regulatory status/Approval from participating countries (mention date in case of US IND) including IRB approvals
Investigator’s Brochure
Case report Form
Informed Consent of subjects/volunteers as per appendix V to Schedule Y
Doc. As per CDSCO guidance doc.
Complete Phase I, II study report if Phase III permission is required
Complete Phase I, II study report if Phase III permission is required
Phase I if Phase II permission is required
SUSAR’s Afdavit from the sponsor that the study has not been discontinued in any country
Table 2: Checklist for Permission For Conducting Clinical Trial (Phase I, II, III) And Global Clinical Trial For Biological Application.
Table 1: Form 44
Table 1 Form 44
Application for grant of permission to import or manufacture a New Drug or to undertake clinical trial.
I/We*………………………………………… (Name of the Authorised Person) of M/s.........................………….. (Full address, Telephone no, Fax No and e-mail) hereby
apply for grant of permission for import of and/or clinical trial or for approval to manufacture a new drug or xed dose combination or subsequent permission for already
approved new drug. The necessary information / data is given below :
I. Particulars of Subject device
I. Generic name
ii.Brand name
iii.Composition of device
iv. Specications/standards of device
v. Qualitative and quantitative particulars of the constituents
vi. Information on sterility and stability of the product
vii. Labeling details
viii. Variations in shape, style or size of the device, if applicable
ix. Physician manual and promotional literature (Literature insert) in English. (If any)
x. Packaging description including pack sizes
xi. Risk classication (in country of origin as well as in 5 GHTF countries i.e. EU, USA, Japan, Canada, Australia)
xii. List of accessories or device to be used in conjunction with subject medical device
xiii. Indication w.r.t. Which clinical study is to be carried out
xiv. Name and address of the manufacturer/contract manufacturer(s)
xv. Regulatory status of the subject device (particularly in 5 GHTF countries i.e. EU, USA, Japan, Canada, Australia)
II.Technical data submitted along with the application as per Annex II. All the information provided with the application should be indexed properly with page no’s.
References
1. Ministry of Health and Family Welfare (1940) The Drugs and Cosmetics act
and rules.
2. CDSCO, Ministry of Health and Family Welfare (2001) Good Clinical Practice:
Guidelines for Clinical Trials on Pharmaceutical Products in India, New Delhi.
3. CDSCO (2010) Guidance for industry on preparation of common technical
document for import/ manufacture and marketing approval of new drugs for
human use.
4. CDSCO. Application for grant of permission to import or manufacture a New
Drug or to undertake clinical trial.
Volume 4 • Issue 2 • 1000140
Pharmaceut Reg Affairs
ISSN: 2167-7689 PROA, an open access journal
Citation: Ramu B, Sathish Kumar M, Ramakrishna M (2015) Current Regulatory Scenario for Conducting Clinical Trials in India 4: 137. doi:
10.4172/2167-7689.1000140
Page 3 of 3
5. CDSCO (2005) Requirements And Guidelines For Permission To Import And / Or
Manufacture Of New Drugs For Sale Or To Undertake Clinical Trials Good Clinical
Practices for Clinical Research in India, Schedule Y.
6. CDSCO (1940) Guidance for Industry on Submission of Clinical Trial Application for
Evaluating Safety and Efcacy Guidance for Industry.
7. Gupta Vishal N, Mohan Reddy C, Pradeep Reddy K, Ajay Kulkarni R,
Shivakumar HG (2012) process of approval of new drug in india with
emphasis on clinical trials. International Journal of Pharmaceutical Sciences
Review and Research 13: 17.
Citation: Ramu B, Sathish Kumar M, Ramakrishna M (2015) Current
Regulatory Scenario for Conducting Clinical Trials in India 4: 137. doi:
10.4172/2167-7689.1000140
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... Therefore, in 2005 the CDSCO amended Schedule Y of the Drugs and Cosmetics Rules of 1945 [25] to eliminate phase lag and provide a collection of clinical trial guidelines and regulations. Details of these modifications have been described previously [25,91] . Furthermore, in 2006, the CDSCO issued a fast-tracking system to decrease the application review period from 16 to 10 w, separating clinical trial applications into class A or B [92] . ...
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Medical companies consider India is above other countries worldwide as an alternative nation for clinical trials due to easily available sources and infrastructure. However, the developing Indian clinical trial industry has been negatively affected by noncompliance with regulations and by reports of unethical trials. Several studies on Indian clinical trial regulations have been conducted and various articles have been published, but only a few researchers evaluated awareness of investigators and members of the ethics committee about previously amended regulations. No study evaluated the knowledge of researchers on the new drugs and clinical trial rules issued in 2019 and also its impacts. Understanding the knowledge of Indian researchers on new drugs and clinical trial rules, including its effect is crucial to determine whether the trials are being conducted in compliance with the new rules and regulations. Thus, this review aimed to evaluate India’s clinical trial regulatory changes based on the existing literature, Indian researcher’s knowledge of the recent changes, and assessment of the impact of the new 2019 regulations, elaborating upon clinical trials in both the global and the Indian context.
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A regulatory process, by which a person/organization/sponsor/innovator gets authorization to launch a drug in the market, is known as drug approval process. In general, a drug approval process comprises of various stages: application to conduct clinical trials, conducting clinical trials, application to marketing authorization of drug and post-marketing studies. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate the marketing of the drugs. This work focuses on the drug approval process in India.
2167-7689 PROA, an open access journal Citation Current Regulatory Scenario for
  • Pharmaceut Reg Affairs
Pharmaceut Reg Affairs ISSN: 2167-7689 PROA, an open access journal Citation: Ramu B, Sathish Kumar M, Ramakrishna M (2015) Current Regulatory Scenario for Conducting Clinical Trials in India 4: 137. doi: 10.4172/2167-7689.1000140
Requirements And Guidelines For Permission To Import And / Or Manufacture Of New Drugs For Sale Or To Undertake Clinical Trials Good Clinical Practices for
CDSCO (2005) Requirements And Guidelines For Permission To Import And / Or Manufacture Of New Drugs For Sale Or To Undertake Clinical Trials Good Clinical Practices for Clinical Research in India, Schedule Y.
Guidance for Industry on Submission of Clinical Trial Application for Evaluating Safety and Efficacy Guidance for Industry
CDSCO (1940) Guidance for Industry on Submission of Clinical Trial Application for Evaluating Safety and Efficacy Guidance for Industry.
Guidance for industry on preparation of common technical document for import/ manufacture and marketing approval of new drugs for human use
CDSCO (2010) Guidance for industry on preparation of common technical document for import/ manufacture and marketing approval of new drugs for human use.
Good Clinical Practice: Guidelines for Clinical Trials on Pharmaceutical Products in India
  • Ministry Cdsco
  • Family Health
  • Welfare
CDSCO, Ministry of Health and Family Welfare (2001) Good Clinical Practice: Guidelines for Clinical Trials on Pharmaceutical Products in India, New Delhi.
Current Regulatory Scenario for Conducting
  • B Ramu
  • Sathish Kumar
  • M Ramakrishna
Citation: Ramu B, Sathish Kumar M, Ramakrishna M (2015) Current Regulatory Scenario for Conducting Clinical Trials in India 4: 137. doi: 10.4172/2167-7689.1000140