Investigational New Drug Application, Functions of CDSCO and DCGI, INDA Process in INDIA, New Drug Application Forms and Rules, INDA Form (sample)

1. Investigational New Drug
Application In India

2. Indian Drug Regulatory Framework
Health is in the concurrent list of Indian constitution.
In India drugs are regulated both at central and state level. At central level
CDSCO (Cental Drug Standard Control Organisation) under the Ministry Of
Health And Family Welfare is responsible for approving new drug, clinical
trials, and licensing of drugs.
At the state level state drug regulatory authorities issues licences to
manufacture approved drugs and to monitor the quality of drugs along with
CDSCO.
In India the regulation of drugs, medical devices, biological and r-DNA
products is distributed within various ministries.

3. Cental Drug Standard Control Organisation
(CDSCO)
• CDSCO under the aegis of Ministry Of Health And Family Welfare have the duty
of regulating and ensuring the quality of medicines and pharmaceuticals under the
Drugs And Cosmetic Act.
• The DCGI (Drug Controller, India) is the main personality of CDSCO responsible
for approving new drugs, clinical trials, Licensing and to ensure quality, safety
and efficacy of pharmaceuticals in India.
• CDSCO is organised in two various Headquaters, “ Zonal Offices ”, “ Sub zonal
offices”, “ Port Offices”, and Laboratory.

6. IND Process In India
• The new drug approval process in India is standardised and well controlled,
involving multiple steps and organizations.
• At the central level, DCGI, under the Ministry of Health and Family Welfare,
approves the drug or medical devices for marketing.
• Manufacturing licenses are approved at the state level by state drug control
authorities.
• Monitoring is also done by state agencies in coordination with the CDSCO.

8. New Drug Definition (122E)
• Not used in the country.
• Approved drug – New claims (indications, dosage, dosage form,
route)
- FDCs (new or modified)
• All vaccines shall be considered as new drug as specified by licensing
authority.
Notes : A new drug is considered to new for the period of 4 years from
the date of its first approval or its inclusion in the Indian
Pharmacopoeia.

9. • Manufacturing, importing, or conducting a clinical trial requires permission from
the licensing authority through the Form 44 application.
• Form 44 requires information as described in Schedule Y of the Drugs and
Cosmetics Act.
• The clinical trials must be conducted in accordance with the ethical principles.
• The Act has a special provision ( Rule 122-A) to accept international trial data or
other information, to allow import, and to waive the clinical trial requirement in
the interest of public health.

10. • A clinical trial may also be waived for drugs that are approved and have been used
in other countries for many years.
• Appendix I, IA and VI of Schedule Y describe the information and data required
for approval of clinical trial and / or import or manufacture of a new drug for
marketing in the country.
• However, requirements for approval of clinical trials and new drugs may vary
depending on the nature of the new drugs.

11. • IND has been defined under Rule 122-DA (3) of Drugs and Cosmetics Rules 1945
as a chemical entity having therapeutic indication but which have never been
earlier tested on humans.
• No clinical trial for new drug for any purpose be conducted without any
permission, in writing, of the Licensing Authority (DCGI).
• Application for conducting clinical trials in India require submission by the
sponsor on Form 44 along with requisite fee (Rs 50k) and documents as provided
under Schedule Y to Drugs and Cosmetics Act 1940.

12. • Data to be submitted along with the application on Form44 to conduct
clinical trials
i. Application on Form 44
ii. Introduction of the drug
iii. Fee Rs 50k through challan form
iv. Chemical and Pharmaceutical information as per Appendix I of
Schedule Y.
v. Animal Pharmacology as per Appendix IV
vi. Animal Toxicology as per Appendix III
vii. Human /Clinical Pharmacology data as per Appendix I
viii. Regulatory status in other countries as per Appendix I.

16. Thank you