How To Get Drug Approval In India?

Drug Approval

This is a fascinating topic, and we think everyone who works in this industry should know How to get drug approval in India. This process is a bit lengthy but not dull like usual. Let’s start with this and get into the topic in detail. This blog will give you the process, required documents, eligibility criteria, and more. 


Pharmaceutical companies need FDA Registration approval to trade or sell fresh prescripted drugs. Drug approval in India should meet and fulfill processes such as preclinical research, clinical research, concept, FDA post-market monitoring, and FDA review. Details like How you will Get Drug Approval In India, and more concise information are already mentioned below.

Who Can Apply For Drug Approval In India?

Anybody registered under a manufacturing license under form 25 & form 28 and The enterprise must have essential regulatory clearance via regulatory bodies. If you fulfil these requirements, you can apply for Drug authorization in India.

What Are The Required Documents For Drug Approval In India?

Below is a list of the essential documents for Drug Approval In India. It is necessary to gather all the documents before applying for registration for Drug Approval in India as it will make the process easier. So follow the mentioned information and check the list mentioned as follows:-

  1. Summaries of Authorized Preclinical Studies (PK/PD and Toxicology) and Reports of Clinical Studies.
  2. Summaries for Conducted Phase I, II, and III trials. Clinical Studies Reports.
  3. Declarations, Sponsor Commitments, and Manufacturer.
  4. CMC Data (containing drug master document, maker’s details, manufacturing records of three groups, drug item information, site master record, COAs, and bunch stability information).

How You Can Apply For Drug Approval In India?

To apply for Drug Approval In India, here is the list of the process in a few easy steps:-

  • Visit the SUGAM Portal
  • Register on the SUGAM Portal
  • Now provide the Application
  • Now, from the New Drug Division drop-down option, select “CT-21.”
  • Give the Pharmaceuticals details, research website information, and other needed details.
  • Provide all the documents asked in Form “CT-21.”
  • Now submit the government fee 
  • Now you will get CT-22/CT-23

What is the Application Process To Get Approval On Drug Manufacturing India?

Here is the application process for Drug Approval In India, Check as it is mentioned below:-

  • Mention the details and fill out form CT -10 to request permission to manufacture ND for analyzing and testing in form CT-11.
  • Provide the Form 30 application to the state FDA for a license to manufacture ND “form-29.”
  • Give the CT-21 application through the SUGAM Portal and attach all the helping documents and the required government fee.
  • After this procedure, CDSCO will check and review your application. 

What are the Requirements to Get Approval For Drug In India?

The requirements for drug approval in India are as follows: clinical investigation, postmarketing surveillance, preclinical investigation, and review of the new drug application. So typically, these are the four essential requirements if you thinking about applying for the Drug Approval in India.

What is the Validity of Drug Approval In India?

There is a 5-year Validity period for Wholesale Drug Approval In India, so renew it under a month before the expiry date of the license of drug license. 

What is the Timeline for Drug Approval In India?

The timeline for Drug Approval In India can take 90 days. In detail, approval is obtained in Form CT-22 (API)/Form CT- 23 (Formulation) from the Central Drug Standard Control Organization, also called CDSCO.

Essential Guidelines for Drug Approval In India

  1. You must provide proper clinical and pre-clinical data for phases I, II, and III
  2. Provide all the management paperwork (GMO/FSC/CCP) failing; then support should be given.
  3. You have to Give three batches of COAs and stability details with CMC Information.
  4. Remember that COAs should be from fresh batches
  5. Every paper that is provided should be genuine and legitimate.
  6. The NDCT 2019 rules must comply with all commitments, including ICF, IB, Label, etc.

How Much Does It Cost To Get Drug Approval In India?

The cost of a drug approval license in India varies according to the time and process. So, talking directly with ELT Corporate is better to avoid confusion and find direct solutions to your problems.

Suspension & Cancellation Process of Drug Approval In India?

Indeed, suppose manufacturers/Importers registration fail to complete the conditions or do not follow the act of the MDR 2017. In that case, they will be liable for the cancellation or suspension of the license. Also, the Central Licensing Authority (CLA) can interrogate manufacturers or importers directly, but this process is lengthy, and they follow the rules.

Who gives Drug Approval In India?

In India, Drug approval is provided by the Central Drug Standard Control Organisation, widely known as CDSCO, under the Directorate General of Health Services and Ministry of Health (DGHS) and Family Welfare, Government of India. If you don’t know these bodies, check the difference between DCGI & CDSCO.


Securing a Drug Approval License in India is mandatory, and it’s punishable if you deal in the market without the license. So, after reading the whole blog, it is clear why it’s important, for whom it is necessary, and how you can get it. So, get a drug license in India, and if you still don’t know the process, then raise your query with and get it done in no time.


What is the life cycle of drug approval?

In short, the Life Cycle of Drug Approval is 10 to 12 years.

Which Drugs are not FDA-Approved?

Here is the short list of the Non-Approved Drugs in India, as mentioned below:-

  1. Morphine
  2. Phenobarbital
  3. Potassium Chloride
  4. Sodium Fluoride

What is the CDSCO Full Form?

The CDSCO stands for the “Central Drug Standard Control Organisation”.

What is the FDA Full Form?

Food and Drug Administration” is the full form of the FDA.


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