New Drug Application (NDA)

New Drug Application (NDA) is an application made by the sponsor to the regulatory authorities for approval to sell and market a new drug in different countries. NDA includes enough information for the regulatory authorities to determine whether the new drug is safe and effective; whether the drug’s benefits outweigh its risks; whether the proposed drug label (package insert) is appropriate; and whether the drug manufacturing standards are adequate. NDA can be broadly divided into different steps


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New Drug Application (NDA)

  1. The submission of application to conduct clinical trials

  2. Conducting clinical trial

  3. Application to marketing authorization of drug by submitting the data collected from the clinical trials

  4. Post marketing surveillance

New Drug Definition as per the New Clinical Trial Rules, 2019

A new drug means;

  • Active pharmaceutical ingredient or phyto-pharmaceutical drug, which has not been approved by the Central Licensing Authority (CLA) with respect to its claims; or

  • Already approved drug but proposed to be marketed with modified or new claims including indication, route of administration, dosage and dosage form; or

  • A fixed dose combination of two or more drugs which are approved separately for specific indication but now proposed to be

    • Combined for the first time in a fixed ratio, or

    • Where the ratio of ingredients is proposed to be changed with certain claims including indication,

    • Route of administration, dosage and dosage form; or

  • A modified or sustained release form of a drug or novel drug delivery system of any drug approved by the CLA; or

  • A vaccine, r-DNA derived product, living modified organism, monoclonal antibody, stem cell derived product, gene therapeutic product or xenografts, intended to be used as drug

The drug approval process in India is governed by CDSCO and the clinical trials should be conducted in accordance to the New Clinical Trial Rules, 2019. For marketing any new drug in the Indian Market, New Drug Application is submitted to CDSCO through the online portal, SUGAM.

Submission of Application

The applicant needs to submit the application by filling Form CT-04 along with all other necessary documents specified under Second Schedule and fees as specified under Sixth Schedule of CT Rules 2019. The data required will depend upon the type of application, phase of the study, stage in drug development process, and/or objective of the study. Following data needs to be submitted along with the NDA.

  • Pre-clinical data

  • Clinical data

  • Drug information

  • Description of manufacturing procedures

  • Payment details and transaction ID

  • Regulatory status in India and in other countries

  • Details of all sites selected and assessment for suitability of sites and investigators (with contact details)

  • EC related information including approval letter and EC registration status of the selected sites

  • Study related document

Central Licensing Authority approval

After reviewing the application, the CLA will either grant the permission to conduct a clinical trial by using form CT-06, or ask the applicant to rectify any deficiency or reject the application by giving reason in writing. In case of rejection, the applicant may request the authorities to reconsider the application within 60 working days from the date of rejection of application. The approval given by the CLA will remain valid for the period of two years from the date of issue, unless extended by CLA.

Time frame for approval:

Upon receipt of the application, the CLA has 90 calendar days to evaluate the application for drugs developed outside India and 30 days for drugs discovered, researched, and manufactured in India. If the CLA does not respond within 30 days to applications for drugs developed in India, the sponsor (applicant) may conclude that permission to conduct the trial has been granted.

Pre-Submission Meeting

Presubmission meetings can be conducted with the CLA or any other officer authorized by the CLA to seek guidance about the requirements of laws and procedures for obtaining license or permission of manufacturing processes, clinical trials and other requirements. The application for a presubmission meeting should be accompanied by documents referred to in the Second Schedule, as available with the applicant to support their proposal along with a fee specified in the Sixth Schedule. CLA, within a period of 30 days, will relate the facts to the applicant in writing and direct them to provide further information or documents as necessary.

Waivers of Local Clinical Trial Data

According to the rule 75, local clinical trials requirements may be waived for import of new drugs. The waiver may be instituted if:

  • The drug is already approved and marketed in certain countries specified by the licensing authority (Rule 101),

  • A new drug is approved in certain countries, while global clinical trial for that drug is ongoing in India with no reports of major unexpected serious adverse events and the probability or evidence of differences in the Indian population is negligible with respect to enzymes or genes involved in the metabolism of the new drug or any factor affecting pharmacokinetics (PK) and pharmacodynamics (PD), safety and efficacy of the new drug on the basis of available information. In this case, the applicant will have to conduct a Phase IV study as per design approved by CLA.

  • The requirement for conducting a Phase IV study may be relaxed in cases where the drug is indicated for life threatening or serious diseases, diseases of special relevance to Indian health scenario, conditions with an unmet need in India, rare diseases for which drugs are not available or available at a high cost or if it is an orphan drug.

  • New drug that have been approved and marketed for more than two years in other countries, submission of data from animal toxicology, reproduction, teratogenic, perinatal, mutagenicity and carcinogenicity studies may be modified or relaxed.

Clinical Trial Requirement

For new drug application, applicant needs to conduct phase I, Phase II and Phase III trial and submit the data to the CLA for marketing authorization. After getting permission to market the drug, phase IV needs to be conducted.

  • Approval by the Ethics committee:

  • Clinical trial shall be initiated at the site only after getting approval letter by the registered Ethics Committee. In case where site is not having a registered Ethics Committee, approval can obtain either from the Ethics committee of other site or Independent Ethics Committee located within the same city or within a radius of 50 kms of the clinical trial site.

  • Approval granted by the Ethics Committee shall be informed to the CLA within fifteen working days.

  • Clinical trial shall be registered with the Clinical Trial Registry before enrolling the first subject for the trial;

  • Clinical trial shall be conducted in accordance with the approved clinical trial protocol and Good Clinical Practices Guidelines

  • Quarterly submission of the enrollment status as appropriate as per the duration of treatment.

  • Electronic submission of six monthly status report of each clinical trial to the CLA through SUGAM portal;

  • Communicating termination of study if any to CLA within 30 working days of termination with reason

  • Submission of analysis report for serious adverse event (SAE) to CLA and Ethics Committee within 14 days of its occurrence

  • Compensation and complete medical management should be provided to the subject in case of adverse event or serious adverse event and details of compensation should be submitted to the CLA within 30 working days.

  • In case of clinical trial related death or permanent disability of any subject during the trial, compensation shall be provided in accordance with Chapter VI and details of compensation provided in such cases shall be intimated to the CLA within thirty working days of receipt of the order issued by the CLA

Inspection of Premises Relating to Clinical Trial

The applicant permitted to conduct clinical trial shall allow the CLA, or officers from CLA to inspect, search or seize, any record, statistical result, document, investigational drug and other related material with or without prior intimation; and reply to queries raised by the inspecting authority in relation to conduct of such clinical trial.

Suspension or Cancellation of Permission to Conduct Clinical Trial

If the applicant permitted to conduct trial fails to comply with any provision of the Act and these rules, the CLA is authorised to issue warning letter describing deficiency, rejects the results or suspend or cancel the permission granted to the applicant, or debar the investigator or sponsor after giving an opportunity to show cause and after affording an opportunity of being heard, by an order in writing. In such case the applicant can make an appeal within 60 working days.

Cliniexperts can help you through the numerous regulations and steps involved in new drug application. CliniExperts provide full spectrum services for the following types of Drug Clinical Trials:

  • Local Clinical Trial -

    Phase I Trial

    ,

    Phase II Trial

    ,

    Phase III Trial

    and Phase IV Trial or Post Marketing Studies (PMS) (exclusively in India)

  • Global Clinical Trial -

    Phase I Trial

    ,

    Phase II Trial

    and Phase III Trial

Reference

New Drugs and Clinical Trials Rules, 2019, Ministry of Health & Fam. Welfare, Notification, G.S.R. 227(E), (March 19, 2019).

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Frequently Asked Questions

What is an “orphan drug” as per the New Drugs and Clinical Trial Rules, 2019?

“Orphan drug” means a drug intended to treat a condition which affects not more than five lakh persons in India.

“New drug” means, (i) a drug, including active pharmaceutical ingredient or phytopharmaceutical drug, which has not been used in the country to any significant extent, except in accordance with the provisions of the Act and the rules made thereunder, as per conditions specified in the labelling thereof and has not been approved as safe and efficacious by the Central Licencing Authority with respect to its claims; or (ii) a drug approved by the Central Licencing Authority for certain claims and proposed to be marketed with modified or new claims including indication, route of administration, dosage and dosage form; or (iii) a fixed dose combination of two or more drugs, approved separately for certain claims and proposed to be combined for the first time in a fixed ratio, or where the ratio of ingredients in an approved combination is proposed to be changed with certain claims including indication, route of administration, dosage and dosage form; or (iv) a modified or sustained release form of a drug or novel drug delivery system of any drug approved by the Central Licencing Authority; or (v) a vaccine, recombinant Deoxyribonucleic Acid (r-DNA) derived product, living modified organism, monoclonal anti-body, stem cell derived product, gene therapeutic product or xenografts, intended to be used as drug; Explanation: The drugs, other than drugs referred to in sub-clauses (iv) and (v), shall continue to be new drugs for a period of four years from the date of their permission granted by the Central Licencing Authority and the drugs referred to in sub-clauses (iv) and (v) shall always be deemed to be new drugs;

Yes. As per clause (w) of rule 2 of the New Drugs and Clinical Trials Rules, 2019 modified/sustained/prolonged/controlled release and NDDS of an approved drug are always considered as new drug and hence, require prior permission from CLA before obtaining the manufacturing license from the SLA for such products.

Any new drugs or investigational new drugs imported for the purpose of clinical trial shall be kept in containers bearing labels, indicating the name of the drug or code number, batch or lot number, wherever applicable, date of manufacture, use before date, storage conditions, name of the institution or organisation or the centre where the clinical trial is proposed to be conducted, name and address of the manufacturer, and the purpose for which it has been imported. Where a new drug or an investigational new drug is imported by the licencee on behalf of another person, the licencee shall indicate on the label of the container of the such drug, the name and address of the importer and the person to whom it is being supplied along with the scientific name of such drug, if known, or the reference which shall enable such drug to be identified and the purpose for which it is manufactured. No person or importer shall alter, obliterate or deface any inscription or mark made on the container, label or wrapper of any new drug imported without permission of the Central Licencing Authority.

A subsequent new drug means a drug approved by the Central Licencing Authority for certain claims and proposed to be marketed with modified or new claims including indication, route of administration, dosage and dosage form. A subsequent new drug also includes a new drug already approved in the country.

Any person or institution or organisation having permanent establishment in India who intends to conduct clinical trial study of a new drug or an investigational new drug can submit application for clinical trial study

Yes. Any sponsor or investigator intended to initiate a clinical trial for new drug or investigational new drug shall obtain permission from CLA in Form CT-06. The applicant shall submit application in Form CT-04 along with all other necessary documents specified under Second Schedule and fees as specified under Sixth Schedule of CT Rules 2019.

In general, the timeline for disposal of an application for conduct of clinical trial study is 90 working days from the date of receipt of application. However, if the drug is discovered in India or research and development of the drug are being done in India and also the drug is proposed to be manufactured and marketed in India then the timeline for disposal of an application for conduct of such clinical study is 30 working days from the date of receipt of application. In such case, if no response is issued by the CDSCO within 30 working days, the clinical trial will be considered to be deemed approved.

Minimum of seven members from medical, non-medical, scientific and non-scientific areas with at least, one lay person; one woman member; one legal expert; one independent member from any other related field such as social scientist or representative of non-governmental voluntary agency or philosopher or ethicist or theologian. At least 50% of members not affiliated with the institute or organization in which EC is constituted. Every member of the EC shall be required to undergo such training and development programs.

An application for grant of permission to conduct clinical trial of new drug or investigational new drug shall be made in Form CT-04. The application should be accompanied by the necessary documents as specified under Second Schedule along with the fees as specified under Sixth Schedule of the NDs & CTs Rules, 2019. Order issued by CDSCO on 10th Apr 2019, Form CT-04 (and other Forms) can be manually completed and uploaded in SUGAM, till all the new Forms are integrated into the online submission portal.


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