This article is about the Central Drugs Standards Control Organization’s Timelines.
Introduction
With a growing population, and a healthy growth rate, 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 regulatory clearances 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 Indian government to allow sales. 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 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/approvals and the DCGI is advised by DTAB and DCC. Listed below are the timelines followed by the regulatory authorities in India to clear the files.
These timelines serve as an estimate and is provided by Morulaa HealthTech as published for public information by the CDSCO. It is important to note that in case of query or explanation, the timeline will be paused and continue from the date of receipt of the response from the manufacturer.
| S.No | Type of Application | Timelines in days |
| 1a. | New Drug including Biological, Medical Devices/Clinical Trials/Global Trials/New Claims in consultation with NDAC/MDAC | 180 |
| 1b. | IND Applications in consultation with IND committee | 180 |
| 1c. | Subsequent New Drug | 120 |
| 1d. | Clinical Trial Protocol Amendments (if consultation of NDAC is not required) | 60 |
| 2 | Fixed Dose Combination in consultation with NDAC | 180 |
| 3 | Import Registration of Drugs and Medical Devices | 270 |
| 4 | Endorsement of Additional Product in Registration Certificate | 120 |
| 5 | Rule 37 & Neutral Code | 60 |
| 6 | NOC for form 29 (Biological and Medical Device) | 60* |
| 7 | CLAA in form 28/28-D/28-E/27-C etc | 60 |
| 8 | Import License in Form 10 | 45 |
| 9 | Test License in Form 11 | 45 |
| 10 | Bioavailability / Bioequivalence (BA/BE) Study | 45 |
| 11 | Extension of Shelf Life for Export | 45 |
| 12 | Export of Biological Samples | 45** |
| 13 | Registration of Cosmetics | 90 |
| 14 | Registration of Ethics Committee | 100 |
| 15 | Post Approval Changes (major) in consultation with CDL, NDAC | 180 |
| 16 | Post Approval Changes (minor) | 90 |
| 17 | BA/Be Site Approval (after receipt of Joint Inspection Report) | 60 |
| 18 | Written confirmation of per EU Directives | 30 |
*If inspection is involved, the timeline is from the date of receipt of the inspection report
**After obtaining BA/BE NOC
