Clinical Research Industry in India


In the last few years clinical research industry has grown with a rapid rate in India and provided various job opportunities to the s of the respective field. In this article I will provide you the knowledge about various prospects of this field and information about the regulation of clinical research in India.

In the year 2009, total capital of clinical research industry in India was $200 million which was raised to $1 billion in 2010. According to a private analysis firm clinical research industry in India is increasing with a steady rate of 65% which is quite significant.


What is clinical research?


In a layman's language, clinical research is that branch of medical science which determines the safety, efficacy and dose of a new drug for a particular drug.
At present there are large no. of incurable diseases in the world and clinical research is the path or procedure to find out the cure for such diseases. Clinical research is divided into four phases-

phase 1 of clinical research


This is the first time when trial of a new drug is done on human beings. New drug is tested on a small group of healthy volunteers who are kept in medical supervision for all the time.
The main of this study is to identify the probable mechanism of action and safety of the drug.

Phase 2 of clinical research


This is done generally on more than 100 patients. The main aim of this trial is to determine further safety and efficacy of the new drug.

Phase 3 of clinical research


This is also called as pre market clinical trial. Once the drug has passed the phase 2, its efficacy and safety are further evaluated on more than 1000 patients. This is generally done at more than one places so also called as multiple phase 2 clinical trial. Once the drug has passed the phase 3, then application is submitted to get permission for the marketing of the drug.

Phase 4 of clinical research


After the marketing of the drug, manufacturers keep an eye on the post market reports of the drug for few years. Therefore this phase of clinical trial is also called as post marketing clinical trial.


Why India is a potential market for clinical research industries?


For various reasons India is attracting many clinical research industries to run their trials here. Here are the possible reasons for the attraction of clinical research industries towards India-

Pool of patients for clinical trials
India has large no. of patients suffering from variety of diseases which includes:
  • 40 million asthma patients

  • 8-10 million HIV patients

  • 3 million cancer patients

  • 34 million diabetes patients

  • 1.5 million diabetes patient

  • 15% of the total population suffering from hypertension

  • This huge pool of patients of different diseases offers the testing of almost all the new drugs for various ailments.

    Geographical and genetic diversity
    India has different geographical areas which offer different climatic conditions for the clinical research. Also on the ground of genetic diversity India contains 6 out of 7 genetic varieties of human races which are helpful in achieving the accurate results.

    Cheaper and faster to carry clinical trials in India
    In India phase 1, 2 and 3 clinical research are 40-80% cheaper than United States. Also the trials are 75% faster here as compared to US.
    Due to this reason now most of the companies are heading towards India for their clinical trials.

    Highly qualified health professionals in India
    India has a large pool of physicians, nurses and technical personnel which help to run a trial smoothly. India offers almost 7 lakh hospitals beds with 221 medical colleges. Thus providing ample infrastructure and qualified personnel for clinical research.

    Well established manufacturing units and clinical research organizations in India
    India boasts of highest no. of manufacturing plant outside the US, numbering 85 in 2007 which have United States Food & Drug Administration's approval. There are also 150 clinical research organizations in India out of which 20 follows the ICH-GCP (International council for health-Good clinical practices) guidelines.


    Regulation of clinical research in India


    There are various laws and acts in India which are made to regulate the clinical research in India. Here is the list of some important acts:

    Medical council of India Act-1956 (amended in 2002)
    This is a very strong Act and holds the provision of punishment also. According to the Act any doctor doing wrong in the trials can be prosecuted.

    Drugs and Cosmetics Act-1940
    Schedule Y of this Act includes all the important guidelines to conduct a clinical trial in the country.

    The Clinical Trials Registery India (CTRI)-2007
    CTRI became mandatory on June 15, 2009. The clinical trials encourage the registration of all the clinical trials carried out in the country. This helps in maintaining the transparency.

    The Ethics committee
    This is the committee constituted in order to check the ethical issues regarding the clinical trials. It consists of a minimum of 7 members. No clinical trial can be started without the prior permission of the ethics committee.

    The Drug controller general of India (DCGI)
    The DCGI is authorised to check and have a control over all the clinical research carried out in the country.


    Future of clinical research in India


    Clinical research is growing with a steep rate in India. In the next 5 years most of the patents in the world will be outdated which will further enhance the growth of clinical research industries in India. I can sense that in next few years clinical research will be one of the major sectors of the nation.


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