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Abbriviated New Drug Application Processin India

*1 Hitesh Chaturvedi, 2Ayush Garg,3Dileep Kumar, 4Udai Bhan Singh Rathore

1, 2.  Department of Pharmaceutics, Pacific College of Pharmacy, Udaipur
3. Department of Pharmacology, Pacific College of Pharmacy, Udaipur
4. Department of Pharmaceutical Chemistry, Pacific College of Pharmacy, Udaipur


The main focus of regulatory authorities ison product’s quality, safety and efficacywith their respective country.It doesnot only involve the process of regulating and monitoring the drugsproduct but also the process of manufacturing, distribution, and promotionof drug product. One of the foremost challenges or goals for regulatory is to ensure the pharmaceutical products are developed as per the regulatory requirement of thatrespective country. All new orgeneric drug products must beapproved,by the respective regulatory agency governing the respective market before a particular product can be introduceinto the market.Every country has its own regulatory authority. Thisregulatory authorityis responsible to enforce the rules and regulations and issue the guidelines to regulate the marketing of the drugs. In this review article we mentioned &thoroughly study about the rule & regulations regarding ANDA registration which are followed process in America Europe and India.

KEY WORDS-ANDA, Registration, Generic, Clinical, NDA


  1. ANDA :

Theword “ANDA” which meansAn Abbreviated New Drug Application (ANDA).ITcontains alldata whichis submitted to FDA’s, Centre for Drug Evaluation and Research (CDER),at Office of Generic Drugs (OGD), the data provides for thethoroughly review and final approval of a generic drug product. After approval, an applicant may manufacture the generic drug product to provide a safe, effective, low cost alternativedosage form to thepublic.

A generic drug product is oneof that is comparable to an innovator drug product in dosage form, strength, route of administration, quality, performance characteristics and intended use.

Important Facts about Generics And Generics Drug Application:

  • Generic drug applications are termed “abbreviated” because they are generally not required toperform preclinical (animal) and clinical (human) data to establish safety and effectiveness.
  • Generic applicants must scientifically demonstrate that their product is bioequivalentwith respect to innovator drug (i.e., performs in the same manner as the innovator drug).
  • Bioequivalence is generally determined by measuring the time taken for generic drug to reach the bloodstream in 24 to 36 healthy volunteers. This gives the idea about the rate of absorption, and bioavailability, of the generic drug which can be compared to that of the innovator drug.
  • The generic version must deliver the same amount of active ingredients into a patient’s bloodstream in the same amount of time as well as the innovator drug.
  • The basis for approving generic copies of drug products was established by the “Drug Price Competition and Patent Term Restoration Act of 1984,” also known as the “Hatch -Waxman Act”. 

This is an application made for generic medicine production. In this process ,the sponsor does not need any type of clinical studies and test.  A person who manufactured generic drug must demonstrate that their product is same as like and bioequivalent to, previously approved brand product. The procedure of ANDA approval has been depicted.

Fig: 1The basic regulation needed in ANDA approval

  1. IND:

Theword “IND” which means “Investigational New Drug”It’s an application filed to the FDA in order to start clinical trials in humans. Ifthe drug was found to be safe from the reports of Preclinical trials(Animals).A firm or institution, called a Sponsor, Who is responsible for submitting the IND application.

Fig: 2 Flow Chart of Investigational New Drug Application

3.NDA :

Theword “NDA” which means “new drug application”.If clinical studies confirm that a new drug is relatively safe and effective, andit will not pose unreasonable risks&interaction to patients, the manufacturer files a New Drug Application (NDA), the actual request to manufacture and sell the drug in that country.

Fig:3 Flow Chart of New Drug Application


When an any company in India want to manufacture or import a new drug it has to apply to seek permission from the licensing authority (Drug Controller general of india) by filling in form 44 also submitting the data as given in schedule Y of drug and cosmetics act 1940 and rules 1945.

In order to prove its efficacy and safety in India population it has to conduct clinical trial accordance with guidelines specified schedule Y and submit the report of such clinical trial in specified format.

But a provision is there in rule-122A of D & C Act 1940 and 1945 that he licensing authority may waive certain trails if he considers that in the interest of public health he may grant permission for import of new drugs basing on the data of the trail done in the other countries. Similarly there is another provision in rule-122A which say that the clinical trial may be waived in the case of new drug which are approved and being used for several years in other countries.

Section 2.4 (a) of schedule Y –Drug and Cosmetics Act 1940 and Rules 1945 says for those;Drug substances which are discovered in India all phase of clinical trial are required. Drug substance which is discovered in other countries other than India; the applicant should submit the data available from other countries and the licensing authority may require him to repeat all the studies or permit him to proceed from phase III clinical trial. The Process of approval of new drug in India is a very complicated process, which should meet necessary requirement along with NDA to FDA.  


To possess this permission a sponsor submits preclinical and clinical test data to NDA for analyzing the drug manufacturing, description of manufacturing procedures. After NDA received by the agency, it undergoes for technical screening and evaluation to ensure that sufficient data and information. At the conclusion of FDA review of an NDA, there are 3 possible actions that can send to sponsor:

  • Not Approvable– In this latter list of deficiencies and explain the reason.
  • Approvable- It means that the drug can be approved but minor deficiencies that can be corrected like labeling changes and possible request commitment to do post approval.
  • Approval– It means that the drug is approved.

If the action is taken is either an approvable or a not approvable, then FDA provides applicant with an opportunity to meet with agency and discuss the deficiencies.


Fig: 4 Drug approval process in India 


Table: 1 Principle of India

Agency One Agency DGCI
Registration Process One Registration Process
TSE/BSE Study data TSE/BSE Study data Required
Braille Code Braille code is not required on labeling
Post approval change Post approval changes; Major quality changes

Moderates quality changes

 Table: 2 Administrative Requirements 

Application MAA Required
Debarment Classification Not Required
Number of copies 1
Approval Timelines 12-18 Months
Fees 50,000 INR
Presentation Paper

 Table: 3 Finished Product Control Requirement 

Justification ICH Q6A
Assay 90-110%
Disintegration Required
Colour Identification Required
Water Content Required

 Table: 4 Manufacturing & Control Requirement 

Number of Batches 1
Packaging Not addressed
Process Validation Required
Batch Size Pilot scale batch

 Table: 5 Stability Requirements 

Number of batches 2 pilot scale/ Production Scale (If API stable)

3 Primary batches (If API unstable)

Condition: Long Term Stability, Accelerated stability Long Term: 300C/70%RH

Accelerated: 400C/75%RH

(0,3,6 month)

Minimum time period at Submission 6 Month Accelerate & 6 Month long term
Container orientation Upright & Inverted
Clause ICH Q1F
QP Certificate Required

 Table: 6 Bioequivalence Requirements 

Reserve Sample
Fasted/Fed As CDSCO recommendation
Retention of sample 3 years from date of filing the application
BE study for generic drugs Against US/EU Australia RLD in any country except Thailand where BE to be done locally against local reference product


The approval of drug in India is the most demanding and new current trend in the world. The primary objective of the regulation governing pharmaceutical product in India is to make safeguard for public health. It is role and responsibility of public regulatory authorities to ensure that pharmaceutical companies comply with regulations. There are legislation that require drugs to be developed, tested, trailed and manufactured in accordance to the guidelines so that they are safe and patient’s well being is protected.



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