Clinical Trial Requirement and Rules

What is Clinical Trial :

Any systematic study  which is performed on pharmaceutical products in human body whether in patients or other volunteers, in order to  verify the effect or to identify any adverse reaction, or to study absorption, distribution, metabolism and excretion of the products with their efficacy and safety.

It is the only way of establishing the safety and efficacy of any drug before its introduction in the market for human use and is preceded by animal trials where the efficacy and side effects are observed in animals and an estimated drug dose is established.

 Clinical Trials are generally divided into Phases I-IV

Phase I :

These are the First trials of a new active ingredient or new formulation in humans and carried out in healthy volunteers. Their purpose is to make a preliminary evaluation of safety, and an initial Pharmacokinetic/ Pharmacodynamic profile of the active ingredient. Trials can be performed  within a small group of people (typically 20–80) to evaluate safety.

Pharmacokinetics (PK) refers to the movement of drugs through the body, whereas pharmacodynamics (PD) refers to the body’s biological response to drugs.

The purpose is to determine whether the new compound is tolerated by the patient’s body and behaves in the predicted way.

Phase II :

The purpose of these studies is to determine activity and to assess the short-term safety of the active ingredient in patients suffering from a disease or condition for which it is intended.

This phase is also concerned with the determination of appropriate dose ranges and the clarification of dose response relationships in order to provide an optimal background for the design of therapeutic trials.

Trial performed with a larger treatment group (typically 100–300)  to determine efficacy and an optimal dose at which the drug shows therapeutic effect with minimal side effect  combined with further monitoring of safety.

Phase III :

This phase involves trials in large patient group for the purpose of determining the short and long term safety efficacy balance of the active ingredient.

Testing with large groups of people (typically 1,000–3,000) to confirm its efficacy, evaluate its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow it to be used safely.

The pattern and the profile of any frequent adverse reactions must be investigated.

The condition under which the trials are conducted   should  be as close as possible to the normal condition of use.

Phase IV :

In this phase studies are performed after the pharmaceutical products  has been marketed and they are based on the product characteristics on which the marketing authorization was granted.

Phase IV trials are conducted as  post marketing efforts to further evaluate the characteristics of the new drug with regard to safety, efficacy, new indications for additional patient populations, and new formulations.

Phase IV clinical trials may include thousands of people and  also called phase 4 clinical trial and post-marketing surveillance trial.

Phase of surveillance after the medicine is made available to doctors, who start prescribing it. The effects are monitored on thousands of patients to help identify any unforeseen side effects.

Clinical Trial Regulatory Requirements in India :

Clinical trials in India are governed by the acts: Drugs and Cosmetics Act, 1940, Medical Council of India Act, 1956 and Central Council for Indian Medicine Act, 1970.

Prerequisites of conducting a clinical trial in India are:

Permission from the Drugs Controller General, India (DCGI)

Approval from respective Ethics Committee where the study is planned

Mandatory registration on the ICMR ( Indian council of Medical Research) maintained website

Clinical Trial New Rules in India :

  • The new rules aim to promote clinical research in India by providing for a predictable, transparent and effective regulation for clinical trials and by ensuring faster accessibility of new drugs to the Indian population.
  • New rules have reduced the time for approving applications, which has now come down to 30 days for drugs manufactured in India and 90 days for those developed outside the country.
  • Drug Controller General of India will decide the compensation in cases of death and permanent disability or other injury to a trial subject.
  • The requirement of a local clinical trial may be waived for approval of a new drug if it is approved and marketed in any of the countries specified by the Drugs Controller General with the approval of the government.
  • Ethics committee will monitor the trials and decide on the amount of compensation in cases of adverse events.
  • It has been mandated that in case of injury to the clinical trial subject, medical management will be provided as long as required as per the opinion of the investigator.
  • New drugs approved for use in select developed markets will be automatically allowed in India provided global trials includes Indian patients.
  • New rules has removed regulations on tests conducted on animals in case of drugs approved and marketed for more than two years in well-regulated overseas drug markets.

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