Introduction
Investing in Indian Healthcare
CDSCO Regulatory Clearances
With a growing population, and a healthy growth rate, the Indian economy is rapidly picking-up. Healthcare companies from all sectors – drugs, medical devices, IVDs are looking to invest into the country and selling their products in India. Partnering with a professional consulting team for CDSCO regulatory clearances and medical device approvals for importation and obtain MD-15 import License in the Indian market is the first step for successful market entry as this process can often be the first bottleneck a company must undergo to ensure safety of products for the Indian market and regulatory clearance by the CDSCO and Indian government to allow sales as per the guidelines set under the Medical device Rules, 2017 (MDR 2017 – DCGI). One of our articles has detailed information on the different entry strategies for foreign investors in India.
Timelines of CDSCO
The Central Drugs Standard Control Organization (CDSCO) is the regulatory body of India that provides regulatory clearances and approvals for medical device manufacturers, drug manufacturers, In-vitro diagnostic companies (IVDs) and Cosmetic manufacturers. The Drug Controller General of India (DCGI) is responsible for the regulations and Medical Device approvals and the DCGI is advised by DTAB and DCC for the approval of Medical Device and provide MD-15 Import License. Listed below are the timelines followed by the regulatory authorities in India to clear the files. This was published on 20th February 2020.
These timelines serve as an estimate and are provided by Morulaa HealthTech as published for public information by the CDSCO. It is important to note that in case of query or explanation notified to the registered user via the SUGAM portal, the timeline will be paused and continue from the date of receipt of the response from the manufacturer.
A) Drugs, Biologicals & Cosmetics
| S.No | Type of Application | Targeted Internal Timeline in Working Days |
|---|---|---|
| 1 | 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 Claims in consultation with Subject Expert Committee (SEC) | 90 | |
| 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 (MD-15) in Drugs & Biologicals | 45 |
| 4 | Import post approval changes for drugs: | |
| a. Major | 180 | |
| b. Minor | 90 | |
| 5 | Endorsement of Additional Product in Registration certificate | 120 |
| 6 | Rule 37 & Neutral Code | 60 |
| 7 | Grant of permission for manufacturing of: | |
| New drug or investigational new drug for CT, BA or BE study or for examination, test and analysis (CT-11) | 7 | |
| Formulation of unapproved API for test or analysis or CT or BA or BE study (CT-14) | 7 | |
| Unapproved active pharmaceutical ingredient for the development of formulation for test or analysis or CT or BA or BE study (CT-15) | 7 | |
| 8 | CLAA in Form 28/28-D/28-E/27-C etc. | 60 |
| 9 | License to import (MD-15) new drug or investigational new drug for the purpose of clinical trial or bioavailability or bioequivalence study or for examination, test and analysis (CT-17) | 7 |
| 10 | Permission to conduct Bioavailability/Bioequivalence (BA/BE) Study for new drug or investigational new drug (CT-07) | 90 |
| 11 | Extension of Shelf Life for export | 45 |
| 12 | Registration of Cosmetics | 90 |
| 13 | Registration of Ethics Committee (CT-02) | 45 |
| 14 | Biological Post Approval Changes | |
| 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 | Written Confirmation (WC) as per EU Directives | 20 |
| 18 | Permission to Import small quantity of drugs for personal use | 3 |
B) Medical Device & In-vitro Diagnostics
| S.No | Type of Application | Timeline in Working Days |
|---|---|---|
| 1 | Grant of Test License to manufacture for test, evaluation, clinical investigations, etc. (MD-13) | 30 |
| 2 | Grant of Import License (MD-15) | 270 |
| 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 |
| 5 | Permission to conduct Clinical Investigation (MD-23) | 90 |
| 6 | Permission to conduct clinical performance evaluation of new in vitro diagnostic medical device (MD-25) | 90 |
| 7 | Permission to import or manufacture medical devices which does not have its predicate device (MD-27) | 120 |
| 8 | Permission to 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 a medical device on behalf of manufacturer (MD-40) | 45 |
| 10 | License/Loan License to Manufacture for Sale or for Distribution of Class A or Class B Medical Device (MD-5)/(MD-6): | |
| a. For Class A Medical Devices: | ||
| i) Grant of license by SLA | 45 | |
| ii) Audit of the manufacturing site by the registered Notified Body from the date of issue of License by SLA | 120 | |
| b. For Class B Medical Devices: | ||
| i) Audit of the manufacturing site by the registered Notified Body from the date of application | 90 | |
| ii) Inspection Report submitted to SLA | 30 | |
| iii) Grant of license by SLA | 20 | |
| 11 | License/Loan License to Manufacture for Sale or for Distribution of Class C or Class D medical device (MD-9)/(MD-10): | |
| a. Completion of scrutiny from 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 approval change in manufacturing Licenses Prior approval to be obtained from CLA/SLA in major change | 45 |
| 13 | Application for post approval change in Import Licenses (MD-15) Prior approval to be obtained from CLA/SLA in major change | 60 |
Note: In case of query or examination, the timeline will be from the date of receipt of the response from the applicant.
How can Morulaa Help:
Morulaa HealthTech as successful regulatory consultants has delivered high level professionalism and quality towards our clients. Contact Harshita Gupta for additional consultation or information.