Issues of clinical trials in india

For studies in many therapeutic areas, the Indian sub-continent is desirable because of its large population of qualified patients, lower trial costs, use of English as the primary language, and a well-trained medical community. Increasing government incentives and regulatory support for research and an increasing number of qualified investigative sites are all major benefits of conducting clinical trials in India.

Issues of clinical trials in india

Avinash Mohapatra and Richa Kachhwaha September 26, Pursuant to an amendment to the Indian Patents Act in Januarydrugs can be made by following both the product and process patenting. This has facilitated the emergence of India as a preferred and sought after destination to conduct clinical trials.

The availability of highly trained physicians, nurses and technical personnel; world class medical facilities; good IT infrastructure; and a robust Intellectual Property Rights regime in India have also helped the cause.

It is no secret that a spate of new drugs and molecules are coming in the market and these new drugs have been mostly tried on individuals from outside the country, predominantly the Caucasian race.

The genetic background, and the physical built of Indians is different from the Westerners. Regulatory Framework and Approval Procedure In recent past few clinical trials were conducted in India as a direct consequence of the regulatory restrictions faced by foreign pharmaceutical companies.

Pursuant to these amendments, the regulatory restrictions were eased and clinical trials facilitated.

Clinical trials have become essential research tools for evaluating the benefits and risks of new interventions for the treatment and prevention of diseases, from cardiovascular disease to . India is fast emerging as one of the most strategic locations for global pharmaceutical companies to conduct their drug research and development. Whether you are looking for a clinical trial to take part in, information about how trials are planned or for trial results you can find it here.

The amendments also addressed responsibilities of sponsors, investigators and the Ethics Committees, besides stipulating guidelines and procedures for the import of drugs for clinical trials in India. The Indian Council of Medical Research, the apex regulatory body for clinical trials, was set up to promote research culture in India and develop infrastructure for clinical trials.

Issues of clinical trials in india

Clinical trials are categorized into two types: Trials for which study protocol has been approved by an authorized regulatory body in one or more developed countries like USA, Canada, U.

Such trials are approved by using a fast-track mechanism within 2 to 6 weeks after required documents are filed with the DCGI.

The DCGI takes 8 to12 weeks to get approval for conducting these trials. There should be an Ethical Committee before any drug is put to clinical trial. There is also a need for adequate data of stage 1 and stage 2 trials as well as trial on animal model giving adequate safety margin for the dosage level at which it is being now tried on human beings.

In the older system, pharmaceutical companies hosting the trial could set up their own committee and have their own investigators for inquiring into serious adverse events.

But the new Rules require the setting up of independent ethics committees under medical institutes to monitor ongoing drug trials.

Issues & Concerns in Conducting Clinical Trials in India

These committees must now be registered with the DCGI before the conduct of clinical drug trials. One of the problems in our country is that people are not educated to the level where they can understand the concept of clinical trials.

It is thus important that clinical trials are conducted in the presence of social worker s. Every person who agrees to take part in the clinical trial should be informed and made to understand what it is all about, its benefits, the likely side effects, and the methods by which we can address the problems which one might face during the course of the trial.Whether you are looking for a clinical trial to take part in, information about how trials are planned or for trial results you can find it here.

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Clinical trials in India: ethical concerns Transnational drug companies are moving their clinical trials business to India, giving a new urgency to clinical trials registry reform there.

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