Proposed Amendments for New Drugs and Clinical Trials Rules 2019

Proposed Amendments for New Drugs and Clinical Trials Rules 2019

Why in News? 

Recently, the Union Health Ministry has proposed amendments to the New Drugs and Clinical Trials (NDCT) Rules, 2019, which is being seen as a move towards creating a more supportive regulatory environment for the pharmaceutical and research industry. 

• The draft notification appeared in the Gazette of India on August 28, 2025, and the government has called for public feedback on it.

Key Proposed Amendments in the New Drugs and Clinical Trials (NDCT) Rules, 2019

• Faster Processing of Testing Licences: The most significant proposal under the amendments is the plan to shorten the time required to obtain a test licence for scientific studies. At present, the approval process can stretch to nearly 90 days, which often delays important research activities. The new proposal seeks to cut this period down to 45 days to allow researchers to initiate studies more quickly. 

• Permission to Notification Model Shift: The draft notification highlights a shift in the approach towards drug testing approvals. Under the existing framework, companies need to secure prior permission from the Central Licensing Authority before initiating most types of drug-related studies. The proposed change, called the  “notify and proceed” model, would allow applicants, except those dealing with high-risk drug categories, to simply notify the authority before starting trials.

• Simplification for BA/BE Studies: The amendments also put a special focus on Bioavailability and Bioequivalence (BA/BE) studies, which are important for proving that generic drugs act in the same way as their branded versions. With the proposed reforms, researchers will experience quicker clearance for BA/BE studies, allowing generic medicines to reach the market in less time. 

Benefits of the Proposed Changes in NDCT Rules, 2019

• Faster Access: The proposed amendment will reduce approval time for test licences. This means that scientists can move from planning to action more quickly, and promising medicines will not get delayed due to paperwork. This step will allow both local and global companies to bring new therapies into trials without losing valuable time.

• Growth of Generic Medicines: The simplified process for Bioavailability and Bioequivalence (BA/BE) will reduce delays in BA/BE approvals. India already supplies nearly 20% of global generic medicines, and faster clearance of BA/BE studies will give companies more confidence to invest in this area. Patients will benefit as generic drugs are often 30 to 80 percent cheaper than branded ones. 

• Better Utilisation of Resources: The Central Drugs Standard Control Organization (CDSCO) often spends a lot of time checking repetitive applications for routine studies. The new “notify and proceed” model will reduce unnecessary workload for officials. Regulators will be able to focus more on high-risk trials that need closer attention, such as those involving genetic research or novel therapies.

• Stronger Global Position: With the new reforms, India will be able to handle approvals more efficiently and become a stronger global hub for clinical trials and drug development. Reports suggest that India currently accounts for around 3% of global clinical trials. If processes become faster, the share could increase significantly by 2030. 

What are New Drugs and Clinical Trials (NDCT) Rules, 2019?

• The NDCT Rules, 2019 were introduced in March 2019, which were aimed at building a clear and updated regulatory system for clinical trials and new drug approvals in India.
• The rules specify that applications for new drugs made in India must receive clearance within 30 days, while those for drugs developed abroad should be decided within 90 days.
• In cases where the Drugs Controller General of India (DCGI) does not issue a decision within these timelines, the application is treated as deemed approved. 
• If a new drug is already approved and marketed in certain well-regulated foreign markets, the requirement for conducting a separate trial in India may be waived by the DCGI with government approval. 
• If a drug has been approved and marketed for more than two years in well-regulated markets overseas, additional animal testing in India is no longer required.
• In the event of death, permanent disability, or serious injury during a trial, the Drug Controller General of India has the authority to decide the compensation amount. 
• The rules clearly state that medical management must be provided free of cost to a trial participant for as long as it is needed, based on the opinion of the investigator. 
• According to the rules, an Ethics Committee monitors ongoing trials and determines the compensation in cases of adverse events. 
• The NDCT Rules clearly define the structure of clinical trials in India, which follow four phases:
  1. Phase I (Clinical Pharmacology Trials): The drug is administered for the first time to a small number of healthy volunteers, usually at least two per dose. The goal is to check if the compound is tolerated and behaves as predicted.
  2. Phase II (Exploratory Trials): The drug is tested on around 10–12 informed patients in multiple centers to evaluate its effectiveness and detect possible side effects.
  3. Phase III (Confirmatory Trials): The drug is tested on a much larger group, usually between 1,000 and 3,000 patients, to gather strong evidence of safety and efficacy in comparison with existing treatments or placebos. Positive results from this phase are submitted to licensing authorities for approval.
  4. Phase IV (Post-Marketing Surveillance): Once the drug is commercially available, doctors prescribe it widely, and the effects are monitored in thousands of patients. The final stage of a clinical trial monitors patients after a drug is launched, helping identify unexpected side effects and confirming its long-term safety.

Regulatory Mechanism of Clinical Trials in India

• Legal Framework: Clinical trials in India are regulated by the Drugs and Cosmetics Act, 1940, the Medical Council of India Act, 1956 and the Central Council for Indian Medicine Act, 1970. These laws provide the foundation for ensuring drug safety, efficacy, and quality.

• Regulatory Bodies: 

• • 1. Central Drugs Standard Control Organization (CDSCO): Oversight of clinical trials in India is carried out by the Central Drugs Standard Control Organization (CDSCO), which serves as the national regulatory body. It functions under the Ministry of Health and Family Welfare and is responsible for approving new drugs, monitoring clinical trials, and regulating drug imports and manufacturing. 

• Drugs Controller General of India (DCGI): At the top of CDSCO’s hierarchy is the Drugs Controller General of India (DCGI). The DCGI plays a central role in granting permission to conduct clinical trials, approving marketing licences for new drugs, ensuring compliance with international standards and determining compensation in cases of death, disability, or serious injury during trials. 

• Clinical Trials Registry – India (CTRI): Since 2007, India has had an official platform known as the Clinical Trials Registry – India (CTRI), maintained by the Indian Council of Medical Research (ICMR). Before participant recruitment begins, all clinical trials in India must be registered on the Clinical Trials Registry – India (CTRI) to ensure transparency.

• Ethics Committee: Every clinical trial must obtain approval from an Ethics Committee at the site where it will be conducted. These committees review the design of the study, the safety protocols, and the informed consent process to ensure that participants are not exposed to unnecessary risks.

Process of Conducting Clinical Trials: To conduct a trial in India, researchers must follow a defined sequence of steps. First, they must obtain permission from the DCGI. Next, they must secure approval from the Ethics Committee at the institution where the trial will be held. After that, the trial must be registered on CTRI. Finally, the trial must be conducted strictly according to ICH-GCP principles.