**Executive Summary:**
This document, dated February 20, 2020, outlines the targeted internal timelines set by the Central Drugs Standard Control Organization (CDSCO) for processing and disposing of various applications related to drugs, biologicals, cosmetics, medical devices, and in-vitro diagnostics. The timelines are specified in working days and exclude the time taken by the applicant to respond to queries. The policy aims to streamline the approval processes within CDSCO.
**Key Points / Main Content:**
* **New Drugs and Biologicals:**
* IND Applications (with SEC consultation): 30 days
* New Drug/Biological/Clinical Trial/Global Clinical Trial Applications (with SEC consultation): 90 days
* Subsequent New Drugs (SND) (with SEC consultation): 90 days
* Fixed Dose Combination (with SEC consultation): 90 days
* **Import-Related:**
* Registration of Drugs/Biologicals: 270 days
* Import License for Drugs/Biologicals: 45 days
* Major Post Approval Changes for Drugs: 180 days
* Minor Post Approval Changes for Drugs: 90 days
* Endorsement of Additional Product in Registration Certificate: 120 days
* Import small quantity of drugs for personal use: 7 days
* **Manufacturing Permissions:**
* New Drug/Investigational New Drug for CT/BA/BE study/Examination/Test/Analysis: 13 days
* Formulation of Unapproved API for Test/Analysis/CT/BA/BE study: 14 days
* Unapproved API for Formulation Development for Test/Analysis/CT/BA/BE study: 15 days
* **Clinical Trials and Studies:**
* CLAA in Form 28/28D/28E/etc.: 60 days
* License to Import New Drug/Investigational New Drug for Clinical Trial/Bioavailability/Bioequivalence study/Examination/Test/Analysis: 17 days
* Permission to Conduct Bioavailability/Bioequivalence (BA/BE) Study for New Drug/Investigational New Drug: 90 days
* Registration of Ethics Committee: 45 days
* Registration of BA/BE study center: 90 days
* **Other Approvals:**
* Extension of Shelf Life for Export: 45 days
* Registration of Cosmetics: 90 days
* Written Confirmation (WC) as per EU Directives: 20 days
* **Biological Post Approval Changes:**
* Major (with CDL/SEC consultation): 180 days
* Minor: 90 days
* **BA/BE Studies for Export:**
* Permission for BA/BE Study and Post Approval Changes: 15 days
* **Medical Devices and In-Vitro Diagnostics:**
* Grant of Test License to manufacture for test, evaluation, clinical investigations, etc.: 30 days
* Grant of Import License: 7 days
* Grant of Test License for import for test, evaluation, clinical investigations, etc.: 30 days
* Permission to conduct Clinical Investigation: 90 days
* Permission to conduct clinical performance evaluation of new in vitro diagnostic medical device: 90 days
* Permission to import or manufacture medical devices which does not have its predicate device: 120 days
* Permission to import or manufacture new in vitro diagnostic medical devices: 90 days
* Certificate of registration to Medical Device Testing Laboratory for carry out Test or Evaluation of: 45 days
* Licence to Manufacture for Sale or for Distribution of Class A or Class B Medical Device: 45 days
* Audit of the manufacturing site by the registered Notified Body from the date of issue of License by SLA: 120 days
* Audit of the manufacturing site by the registered Notified Body from the date of application: 90 days
* Inspection Report submitted to SLA: 30 days
* Grant of license by SLA: 0 days
* Licence/Loan License to Manufacture for Sale or for Distribution of Class C or Class D: 45 days
* Inspection of manufacturing premises from the date of application: 60 days
* Grant of license from the date of receipt of Inspection report: 45 days
* Post approval change in manufacturing Licenses: 45 days
* Post approval change in Import Licenses: 60 days
* **General Note:** Timelines exclude applicant response time to queries.
**Impact Analysis:**
**Applicants (Pharmaceutical Companies, Manufacturers, Importers, etc.):**
* *Impact:* Provides clarity on expected processing times for various applications, enabling better planning and resource allocation.
* *Action Required:* Be aware of the timelines for different application types and respond promptly to any queries from CDSCO to avoid delays.
**CDSCO (Central Drugs Standard Control Organization):**
* *Impact:* Sets internal targets for application processing, promoting efficiency and accountability.
* *Action Required:* Adhere to the defined timelines for processing applications, ensuring timely communication and resolution of queries.
**Subject Expert Committee (SEC) and Central Drugs Laboratory (CDL):**
* *Impact:* Informs the timeline for consultation and input required for specific application types.
* *Action Required:* Prioritize and expedite the review and consultation process for applications requiring SEC or CDL input, aligning with the overall timelines.
**State Licensing Authorities (SLA):**
* *Impact:* Sets internal targets for the granting of licenses.
* *Action Required:* Adhere to the defined timelines for granting licenses, ensuring timely communication and resolution of queries.
Key Entities Referenced
CDSCO: Central Drugs Standard Control Organization, the national regulatory body for pharmaceuticals and medical devices in India.
Drugs, Biologicals Cosmetics: Refers to the categories of products regulated under the policy, including drugs, biological products, and cosmetics.
Subject Expert Committee SEC: A committee of experts consulted during the review process for certain applications.
New Drugs: A category of pharmaceutical products that are subject to specific regulatory review processes.
Clinical Trials: Research studies conducted to evaluate the safety and efficacy of new drugs or medical treatments.
Medical Device: An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory which is: recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them
Bioavailability Bioequivalence BABE Study: Studies conducted to determine the rate and extent to which the active ingredient or active moiety is absorbed from a drug product and becomes available at the site of action.
EU Directives: Regulations set by the European Union that serve as standards for Written Confirmation (WC).
Dated 20.02.2020
Targeted internal timeline for processing and disposal of complete applications by
CDSCO
A) Drugs, Biologicals & Cosmetics
Targeted
S.No Type of application internal timeline
in working days
New Drugs/ Investigational New Drugs
a. IND Applications in consultation with Subject Expert Committee (SEC) 30
\ b. New Drug including Biological, /Clinical Trials/Global Clinical Trials/New 90)
, Claims in consultation with Subject Expert Committee (SEC) '
c. Subsequent New Drugs (SND) with Subject Expert Committee (SEC) 90
d. Fixed Dose Combination in consultation with Subject Expert Committee (SEC) 90
2 Import Registration of Drugs & Biologicals
270
3. Import License in Drugs & Biological 45
4. Import post approval changes for drugs :
a. Major
180
b. Minor
90
3. Endorsement of Additional Product in Registration certificate 120
6. Rule 37 & Neutral Code
60
Grant of permission for manufacturing of :
a. New drug or investigational new drug for CT. BA or BE study or for examination,
7 test and analysis (CT — 11) 3
, b. Formulation of unapproved API for test or analysis or CT or BA or BE study (CT-
14)
c. Unapproved active pharmaceutical ingredient for the development of formulation for
test_or analysis or CT_or BA or BE study (CT- 15)
8. CLAA in Form 28/28-D128-E/27-C ete. 60
9 Licence to import new drug or investigational new drug for the purpose of clinical trial or 4
, bioavailability or bioequivalence study or for examination, test and analysis (CT-17)
10. P . ermis —sion to conduct Bioavailability /Bioequivalence (BA/BE) Study for new drug or
Investigati onal new drug (CT-07) 90
I. Extension of Shelf Life for export
45
12. Registration of Cosmetics
90
13. Registration of Ethics Committee (CT-02) 45
Biological Post Approval Changes
14. a. Major in consultation with CDL. SEC 180
b. Minor
90
15. Permission for BA-BE study and its Post Approval Changes for export purpose 15
16. Registration of BA/ BE study center (CT-09) 90
17, Writtcn Confirmation (WC) as per EU Directives 20
18. Permission to lmport small quantity of drugs for personal use 3B) Medical Device & In-vitro Diagnostics:
Timeline in
Type of application
S.No
working days
l. Grant of Test License to manufacture for test, evaluation. clinical investigations, etc. (MD-13) 30
2. Grant of
770
Import License (MD-15)
3. Grant of Test License for import for test, evaluation, clinical investigations, etc.(MD-17) 30
4, Permission to Import small quantity of medical device for personal use.(MD-21) 7
90
5. Permission to conduct Clinical Investigation (MD-23)
6. Permission to conduct clinical performance evaluation of new in vitro diagnostic medical device 90
7. ( PeM rD m- i2 s5 s) ion to import or manufacture medical devices which does not have its predicate 120
8. d Pe erv mi ic se s( iM oD n- t2 o7 ) import or manufacture new in vitro diagnostic medical devices{MD-29) 90
9. Certificate of registration to Medical Device Testing Laboratory for carry out Test or Evaluation of 45
10. a L im ce ed ni cc ea /l L ode av ni Lc ie co en n sb ee h toa l Mf a o nf u fm aa cnu tf ua rc et fu or re r S a( lM e D o- r4 f0 o) r Distribution of Class A or Class B Medical
Device (MD-5)/(MD-6):
a. For Class A Medical Devices:
45
i) Grant of license by SLA
ii) Audit of the manufacturing site by the registered Notified Body from the date of issue of 120
License by SLA
b. For Class B Medical Devices:
i) Audit of the manufacturing site by the registered Notified Body from the date of application 90
30
ii) Inspection Report submitted to SLA
0
iii) Grant of license by SLA
11. Licence/Loan License to Manufacture for Sale
or for Distribution of Class C or Class D
m ae . d Ci oc ma pl ld ee tv ii oc ne o( fM D sc- r9 u) t/ in( yM D f- r o1 m0) : the date of online submission of application 45
b. Inspection of manufacturing premises from the date of application 60
c. Grant of license from the date of receipt of Inspection report. 45
12. Application for post app roval change in 45
manufacturing Licenses
Prior approval to be obtained from CLA/SLA in major change
13. Applicati on for post approval change in Import 60
Licenses
Prior approval to be obtained from CLA/SLA in major change
Note: In case of query , the time taken for response by applicant is not included in these time line and it will be adjusted
accordingly . from the date of receipt of the response from the applicant.