Amendments to New Drugs and Clinical Trials (NDCT) Rules, 2019

Context: Union Ministry of Health & Family Welfare has notified amendments to New Drugs and Clinical Trial (NDCT) Rules, 2019 to reduce regulatory burden and promote ease of doing business. 

Salient Features of Amendments in New Drugs and Clinical Trials (NDCT) Rule, 2019

Dedicated online modules will be made available on National Single Window System (NSWS) and SUGAM portal, allowing pharma industry to submit intimations in a transparent & hassle-free manner. 

Benefits of the reforms

• Substantial benefits for ensuring public health and safety.
• Facilitate quicker initiation of BA/BE studies, testing and examination of drugs for research purposes.
• Minimization of delays across the entire drug development life-cycle and approval.
• Promotes R&D led growth of Indian pharma industry.
• Aligns domestic regulations with global best practices.
• Strengthens India’s position as a preferred global destination for pharma R&D.
• Ease of Regulation: Allow CDSCO to optimize utilization of its existing manpower, enhancing efficiency & effectiveness of regulatory oversight.
• Trust based regulatory reforms: The reliance on prior-intimation for pharmaceutical testing highlights Government’s commitment to trust-based regulatory reforms and ease of doing business.

About New Drugs and Clinical Trials Rules (NDCT), 2019

New Drugs and Clinical Trials Rules, 2019 were published under the Drugs and Cosmetics Act, 1940 by the Union Ministry of Health and Family Welfare. 

Salient Features of New Drugs & Clinical Trial Rules (NDCT), 2019

• Apply to all new drugs, investigational new drugs for human use, clinical trial, bio-equivalence study, bio-availability study and Ethics Committee.
• The Drug Controller General of India (DCGI) under the Union Ministry of Health & Family Welfare has been designated as the Central Licensing Authority for NDCT Rules.
• Definition of Orphan Drug: Defined Orphan Drugs for the first time as a drug intended to treat a condition which affects not more than five lakh persons in India.
• Definition of New Drug: New drugs for the purpose of clinical trials has been defined as:
  • A drug which has not been used in India to a significant extent and has not been approved as safe and efficacious by the Central Licensing Authority (CLA) with respect to its claims.
  • A drug approved by the CLA for certain claims and proposed to be marketed for modified or new claims including indication, route of administration, dosage or dosage form.
  • A fixed dose combination of two or more drugs, approved separately for certain claims and proposed to be combined in a fixed ratio or where the ratio of ingredients is an already approved combination is proposed to be changed with certain claims.
  • A modified or sustained release form of a drug or novel drug delivery system of any drug approved by CLA.
  • A vaccine, recombinant deoxyribonucleic acid (r-DNA) derived product, living modified organism, monoclonal antibody, stem cell derived product, gene therapeutic product or xenografts, intended to be used as a drug.
• Fixed Timelines for Disposal of Clinical Trials:
  • Drugs developed outside India: Disposal of clinical trial applications within 90 days.
  • New Drug discovered, researched and manufactured in India: Disposal of clinical trial applications within 30 days. Deemed approval in case of no communication is received from the Drug Controller.

• Waiver of clinical trials:
  • If a drug is approved and marketed in any of the countries to be specified by the Drug Controller.
  • For import of new drugs for which the Drug Controller has already granted permission to conduct a global clinical trial that is ongoing in India and in the meantime has been approved in a country specified by the Drug Controller.
  • New drugs approved for use in EU, UK, Australia, Japan & US will be automatically allowed in India, provided clinical trials include Indian patients.
• Ethics Committee: Ethics Committee needs to be set up and registered by anyone who intends to conduct clinical trials or similar studies. Clinical Trials/Studies can be conducted only with approval of this committee.
  • The Ethics Committee will have to be registered with the Central Licensing Authority (CLA) which will be valid for 5 years.
  • In case of an adverse event during a clinical trial, the Ethics Committee will analyse relevant documents related to such events and present the report to CLA.
• Compensation in case of death or injury of new drug or investigational new drug
  • Provisions for compensation of legal heir of clinical trial subject in case of death, permanent injury that occurs during clinical trial by the sponsor or its representative.
  • In case of injury being non-permanent in nature, compensation to be provided for loss of wages of the subject.

• Manufacture of New Drugs for Clinical Trials: Permission from the CLA must be obtained to manufacture a new drug for conducting a clinical trial or similar studies which will be valid for three years.
• Import of new drugs for clinical trial: Permission from the CLA must be obtained to import a new drug for conducting a clinical trial or similar studies which will be valid for three years.
• Strict informed consent requirements: Provide for detailed, written information about risks and voluntary participation. There is a need for audio-visual recording for vulnerable participants in clinical trials of new drugs.

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