Clinical Trials Approval in India

The “ central drug standard control organization “ CDSCO is a national regulatory authority (NRA) of India which comes under the directorate general of health services and the ministry of health and ministry of child and family affairs of the government of India. CDSCO gives approval for drugs to direct clinical trials. CDSCO also gives a quality check to the imported drugs. CDSCO also sets the standards for imported drugs in India. CDSCO( central drugs standard control organization also coordinates with the state drug control organization and helps them with expert advice and training to maintain uniformity in the implementation of drugs and cosmetic arts. The main role of CDSCO is to give permits for the license of certain specialized types of critical drugs. Global Clinical Trial means any clinical trial which is conducted as part of multinational (more than one country) clinical development for design and development for approval of a new drug worldwide. A clinical Trial means a systematic study of any new drug in human subject to generate data for discovering and/or verifying the clinical, pharmacological (including pharmacodynamics and pharmacokinetics), and/or adverse effects with the goal of determining the new drug's safety and/or efficacy. Clinical trials in India are governed by the Drugs and Cosmetics Act, 1940, and its Rules, 1945. A "trial" is a clinical research study in which a drug or medical equipment is tested or studied to see if it is a safe and effective therapy for individuals.

A clinical study, for example, may be used to assess the efficacy of a novel medicine for the treatment of Parkinson's disease. Many novel treatments and therapies are discovered to work in the lab and to be safe and effective in animal studies. However, before NAFDAC can approve pharmaceuticals and devices and doctors may prescribe them to patients, they must be demonstrated to be safe and effective for individuals. NAFDAC has tight guidelines for conducting clinical trials. These guidelines are in place to protect the safety of all participants. Clinical trials are an important research technique for furthering medical knowledge and improving patient care. Clinical research is only conducted when doctors are unsure whether a novel strategy is effective and safe in humans, as well as which therapies or tactics are appropriate for specific illnesses or groups of people. Clinical trials are critical for discovering novel treatments for diseases, as well as new techniques to detect, diagnose, and prevent disease development. Clinical trials can demonstrate to researchers what works and doesn't work in people, which isn't possible to discover in the lab or with animals. Clinical trials can assist doctors in determining if the risks of a new treatment are acceptable when compared to the possible benefits. The outcomes of clinical trials are unknown to researchers. 

(They wouldn't have to go through the trials if they did!) 

Patients may find it difficult to determine whether or not to participate in a clinical trial because of this uncertainty. 

While patient volunteers have occasionally been harmed by a clinical trial's therapy or procedure, millions of patients have benefited because others before them volunteered to participate in a trial that resulted in a new, more effective treatment. While clinical trials are vital, the decision to participate in one is a personal one that is based on your specific circumstances. 

When presented with a clinical study, you and your doctor must assess the advantages against the dangers and decide what is best for you. 

According to the American Cancer Society, around 1,000 potential treatments are examined before they are approved for clinical trials. Before a clinical trial, new cancer treatments are typically explored for at least six years (and occasionally much longer). Typically, by the time a medicine reaches the stage of a clinical trial, it has been determined to be both safe and effective. In certain circumstances, a drug is already FDA-approved and widely used in one ailment, but the clinical trial is examining it in a different disease.

When a new drug gets introduced in India, Then it must go through the 4 phase’s process of clinical trials. There are some documents required in every phase of the clinical trials. Those documents are as follows:

• Form 44
• Treasury Challan of INR 50,000 (for Phase- 1) / 25,000/-(for Phase-II/III clinical trials).
• Source of bulk drugs /raw materials.
• We must give them a data about Chemical and pharmaceutical information: Information on active ingredients, Data on Formulation:
• Animal Pharmacology
• Animal Toxicology
• Human / Clinical pharmacology (Phase 1)
• Therapeutic exploratory trials (Phase II)
• Therapeutic confirmatory trials (Phase III)
• Special studies - Bio-availability / Bioequivalence.
• Regulatory status in other countries 
• Prescribing information
• Application in Form -12 along with T-Challan requisite fees (in case of import of investigational products)

Below are each phase described in detail. The number of study subjects and sites to be involved in the conduct of the clinical trials will depend upon the nature and objective of the study.

1st phase:-  In the first phase of clinical trials, Researchers test a novel drug or a newly introduced drug as treatment in a small group of normal, healthy volunteers (approximately 20 to 80) for the first time in clinical trials to evaluate its safety, determine a safe dosage range, and discover side effects.

2nd phase:-  In the second phase of clinical trials, the observer will observe if the drug or therapy is successful, and to further examine its safety, the study drug or treatment is given to a wider group of people (approximately 100 to 300), including patients with the specific ailment.

3rd phase:- In the third phase of the clinical trials, the study of a drug or therapy is administered to large groups of people (ranging from 1,000 to 3,000), including patients, in order to validate its effectiveness, monitor side effects, compare it to other commonly used therapies, and collect data that will allow the drug or treatment to be used safely.

4th phase:- In the fourth and the last phase of clinical trials, clinical trials are conducted after the DCGI has approved and commercialized a medicine or treatment for public use. These studies will continue to evaluate the drug or treatment in order to gain data on its effect on various demographics as well as any long-term negative effects. 

Academic Trials

"Academic clinical trial" refers to a clinical trial of a drug already approved for a specific claim that is initiated by any investigator, academic, or research institution for a new indication, new route of administration, new dose or new dosage form, and the results of which are used only for academic or research purposes and not for seeking approval from the Central Licensing Authority or regulatory authority of any country for marketing or commercial purposes.

There is a basic fee structure for every single Phase of the clinical trial. The basic fee amount is 3, 00,000 Rupees for Phase I (human) clinical trials. 2, 00,000 Rupees for Phase II (exploratory) clinical trials. 2, 00,000 Rupees for Phase III (confirmatory) clinical trials. 2, 00,000 Rupees for Phase IV clinical trials.

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