REGULATION ON NEW DRUGS

PRATEEK CHHAJERPGDPM-05

200IIHMR

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.

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.

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.

• 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.

TYPES OF NEW DRUGas 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).

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

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

• 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

• 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

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

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

7. Human /clinical pharmacology (phase I)8. Therapeutic exploratory trials (phase II)9. Therapeutic confirmatory trials (phase III)10.Special studies11.Regulatory status in other countries12.Prescribing information & draft specimen of label

& carton13.Copy of license in form-2914.Samples and Testing Protocol/s

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.

• 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.

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

THANK YOU