The document outlines India's regulations for new drugs. It defines new drugs and explains that they must demonstrate safety and efficacy through clinical trials before approval. It describes the general process which involves obtaining a license to manufacture test batches and approval from the Drugs Controller General of India to conduct clinical trials. Four phases of clinical trials are required to generate the necessary data for marketing authorization. The types of new drugs are defined and the documents required at each stage of clinical trials and for final marketing approval are detailed.

1. REGULATION ON
NEW DRUGS
PRATEEK CHHAJER
PGDPM-05
200
IIHMR

2. INTRODUCTION
• New drugs as define under Rule 122-E of D&C
Rules include unapproved drugs, modified or new
claims, namely, indications, dosage forms
(including sustained release dosage form) and
route of administration of already approved drugs
and combination of two or more drugs.
• A new drug shall continue to be considered as
new drug for a period of four years from the date
of its first approval or its inclusion in the Indian
Pharmacopoeia, whichever is earlier.

3. NEED FOR REGULATION
• Demonstration of safety and efficacy of the NEW
drug product for humans use is essential before
the drug can be approved marketing in the
country.
• The Rules 122A, 122B and 122D, 122 DA,
122DAA, 122E of D&C Rules and Appendix I, IA
and VI of Schedule Y, describe the
information/data required for approval of clinical
trial.

4. GENERAL
CONSIDERARTIONS
• The office of DCG (I) grants approval of new drugs
in the country including Investigational New Drugs
(IND).
• For development of any new drug the applicant is
required to obtain license in Form-29 from State
Licensing Authority based on NOC obtained from
CDSCO.
• Test batches of new drugs for development and
generation of data of any new drug should be
manufactured only after obtaining the license in
Form-29.

5. • For permission to import or manufacture of new
drug substances and its formulations for marketing
in the country, applicant is required to file
application in Form 44 along with prescribed fees
in the form of treasury Challan and all relevant
data as per Schedule Y to Drugs and Cosmetics
Rules.

6. TYPES OF NEW DRUG
as defined by CDSCO
1. New Chemical Entity – developed in India as an IND and not
marketed anywhere in world.
2. New Chemical Entity approved & marketed in other countries
not approved in India.
3. New Chemical Entity being developed in other countries and
not marketed anywhere in world.
4. A drug already approved by the Licensing Authority
mentioned in Rule 21 for certain claims, which is now
proposed to be marketed with modified or new claims.
5. A fixed dose combination of two or more drugs, individually
approved earlier for certain claims, which are now proposed
to be combined for the first time in a fixed ratio.
6. A New Drug already approved in the country (within four years
of approval of new drugs).

7. CLINICAL TRIAL APPROVAL
• For new drug substances discovered in India,
clinical trials are required to be carried out in India
right from Phase I. For new drug substances
discovered in countries other than India, Phase I
data as required along with the application.
• After submission of Phase I data generated
outside India to the Licensing Authority,
permission may be granted to repeat Phase I trials
and/or to conduct Phase II trials

8. DOCUMENTS
FOR CLINICAL TRIAL APPROVAL
1. Form 44
2. Treasury Challan of INR 50,000 (for Phase- I) /
25,000/- (for Phase-II/III clinical trials).
3. Source of bulk drugs /raw materials
4. Chemical and pharmaceutical information
5. Animal Pharmacology
6. Animal toxicology

9. • FOR PHASE I:
– Repeat-dose systemic toxicity studies
– Male fertility study
– In-vitro genotoxicity tests
– Allergenicity / Hypersensitivity tests
• FOR PHASE II
– Repeat-dose systemic toxicity studies
– In-vivo genotoxicity tests

10. • FOR PHASE III
– Repeat-dose systemic toxicity studies
– Reproductive/developmental toxicity studies
– Carcinogenicity studies
• FOR PHASE IV
– Complete study reports of all trial phases along with a
legal undertaking in form of an affidavit by the
applicant.
Once phase IV is approved the drug is ready for marketing

11. DOCUMENTS
FOR MARKETING APPROVAL
1. Form 44
2. Treasury Challan of INR 50,000
3. Source of bulk drugs /raw materials
– Manufacture the API
– Obtain the API from another
manufacturer which is not yet approved
by DCGI

12. 4. Chemical and pharmaceutical information
including
– Information on active ingredients: Drug
information (Generic Name, Chemical
Name or INN) & Physicochemical Data
– Data on Formulation
4. Animal pharmacology
5. Animal toxicology

13. 7. Human /clinical pharmacology (phase I)
8. Therapeutic exploratory trials (phase II)
9. Therapeutic confirmatory trials (phase III)
10.Special studies
11.Regulatory status in other countries
12.Prescribing information & draft specimen of label
& carton
13.Copy of license in form-29
14.Samples and Testing Protocol/s

15. CONCLUSION
• Generally, the drug approval process comprised
mainly the two steps, application to conduct
clinical trial and application to the regulatory
authority for marketing authorization of drug.
• In all countries, information submitted to regulatory
authorities regarding the quality, safety and
efficacy of drug is similar; however, the time, fee
and review process of clinical trials and marketing
authorization application differs.

16. • For the purpose of harmonization, ICH has taken
major steps for recommendations in the uniform
interpretation and application of technical
guidelines and requirements.
• This step will ultimately reduce the need to
duplicate work carried out during the research and
development of new drugs.

17. *By Centralized Procedure; MAA-Marketing Authorization Application, IND-Investigational New
Drug, CTA-Clinical Trial Authorization, DNA-Data Not Available.

18. THANK YOU