Clinical Trials Approval in India

Imagine having a drug that makes you unhealthy and later revealing that the drug was incompetent to cure your disease and could become the reason for some side effects. It can be fatal for the public at large who are consuming that drug. Therefore, clinical trials are essential before allowing such new drugs to distribute. The Central Drug Standard Control Organization (CDSCO) is India's national regulatory authority (NRA) responsible for Clinical Trial Approval in India. CDSCO also gives a quality check to the imported drugs and sets standards. CDSCO (Central Drugs Standard Control Organization) coordinates with the State Drug Control Organization and helps them with expert advice and training to maintain uniformity in implementing the Drugs and Cosmetics Act. The primary role of CDSCO is to give permits for the license of certain specialized types of critical drugs.

What is a Clinical Trial?

The Clinical Trial definition describes that a clinical trial is a structured investigation involving human subjects to study a new or investigational new drug. Its purpose is to collect data on the drug's clinical effects, pharmacology, pharmacodynamics and pharmacokinetics, and adverse effects. The main objective is to evaluate the drug's safety, efficacy, and tolerance.

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.

Why Clinical Trials Are Executed?

Clinical trials are an essential research technique for furthering medical knowledge and improving patient care. Doctors conduct clinical research when unsure whether a novel strategy is effective and safe in humans and which therapies or tactics are appropriate for specific illnesses or groups. Clinical trials are critical for discovering novel disease treatments and 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 compared to the possible benefits. The outcomes of clinical trials are unknown to researchers.

Public Participation in Clinical Trials

Because of this uncertainty, patients may find it difficult to determine whether or not to participate in a clinical trial. While patient volunteers rarely get 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 personal and 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.

Clinical trials come with many benefits to various stakeholders in the medical industry. Some of the significant advantages are as follows-

• It helps researchers and doctors to develop the most effective drug possible with the help of reports generated in trials.
• Researchers and Doctors rectify any shortcomings during the trial period.
• It prevents the circulation of immature drugs in the public, which may also be fatal in extreme cases.
• Straight forward approval process expedites the timeline of the availability of the new drug for general use.
• The medical professionals share knowledge regarding the new treatment and procedures.
• Participants get early access to the newly developed medicines for the treatment.
• Participants get focused treatment and a chance to provide valuable feedback to the doctors for the welfare of society and potential patients.

There are four clinical trial phases as given below-

Phase I of Clinical Trials

• Researchers test a novel drug or a newly introduced drug.
• Researchers test the new drug as treatment in a small group of volunteers.
• They select approximately twenty to eighty healthy volunteers for the first time.
• The main focus remains the safety of the drug in this phase.
• During the trials, they also discover the drug's safe dosage range and side effects.

Phase II of Clinical Trials

• In this phase of clinical trial approval in india, the observer will observe if the drug or therapy is successful.
• After examining the safety of the new drug, a broader group of people join the trials.
• This time the number of participants can be from 100 to 300.
• In this phase, the participants may include patients with specific ailments.

Phase III of Clinical Trials

• In the third phase, even a larger group of patients and healthy people take participation in the clinical trials.
• In this phase, one thousand to three thousand people consume the drug or the treatment.
• This group of participants can also include patients undergoing specific treatment.
• Researchers validate the drug's effectiveness and monitor its side effects in this phase.
• The researchers also compare the drug with commonly used therapies, and relevant data is collected to use this treatment safely.

Phase IV of Clinical Trials

• In the fourth and 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 to gain data on its effect on various demographics and any long-term adverse effects.

When a new drug gets introduced in India, it must go through the four phases of clinical trials. There are some documents required in every phase of the clinical trial approval. Those documents are as follows-

• Form CT-04
• Detailed Drug Information
• Animal Pharmacology
• Animal Toxicology
• Human Pharmacology
• Therapeutic exploratory trials
• Therapeutic confirmatory trials
• Regulatory status in other countries
• Prescribing Information
• Samples and Testing Protocols
• Global Clinical Trial
• Drug Manufacturing Licence
• Applicable Fee Receipt

You need to contact Corpseed; our expert will do your job. The approval certificate will be delivered to you via post or e-mail. The procedure to get the approval to conduct a clinical trial in India includes the following steps-

• As per the latest clinical trial registration rules, a registered ethics committee oversees the site for clinical trials throughout the trials.
• The applicant shall apply form CT-04 to obtain clinical trials approval in India.
• The application of clinical trial registration must be accompanied by the documents mentioned above.
• The Central Licensing Authority examines the application and scrutinizes the documents.
• The Licensing Authority may also conduct further inquiries about the application if necessary.
• If satisfied with the application, the Central Licensing Authority may issue permission to conduct clinical trials under Form CT-06.
• The Central Licensing Authority decides on such an application within ninety days and issues the permit; otherwise, it rejects the application with reasons in writing.

There is a basic fee structure for every single clinical trial approval phase. The basic fee 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.

Corpseed, a one-stop solution service, facilitates and ensures a hassle-free procedure to obtain the requisite permissions and documents for clinical trial approval in India. We at Corpseed facilitate end-to-end solutions for all Indian Regulatory compliance. Some of the significant highlights of Corpseed are as follows-

• Free consultation on the applicable standard on the said end product
• Assistance in preparing and managing documents
• Application filling
• Liaisoning with the department officials on behalf of the applicant
• Timely approval in predefined ETA
• Quality service with minimum charges