Clinical Trials

The Indian Clinical trials and Research industry accounts for $ 500 million and is projected to more than double and cross $1 billion mark by 2016. Driven by large and easy to access population with much lower cost than the developed world, India has emerged as a preferred hub for clinical trials in the past one decade.

As per a study by Rabo India Finance, a subsidiary of the Netherlands based Rabo Bank, India has the largest pool of naive patients in many disease areas, including cancer and diabetes. The report also highlights the low cost of trials as India’s biggest advantage. Furthermore, the availability of specialist hospitals with state-of-the-art facilities staffed by a high number of clinicians trained in good clinical practice and a large workforce proficient in English, all made India suitable for clinical trials.

With the recent disclosure of issues  in conducting clinical trials and exploitation by MNCs, the Government of India has finally taken the cognizance of the fact and decided to regulate the industry by introducing certain strict norms and regulations. These new rules will help in avoiding the lapses by pharma MNCs, raise compensation, and put in place the new guidelines for conducting clinical trials.

The Government has made it mandatory for Investigators and sponsors to address issues relating to serious adverse events such as deaths and outlined the fixed a formula for awarding adequate compensation. Three independent expert committees have been constituted for examination of reports serious adverse events (SAE) of deaths occurred during clinical trials. In case of clinical trial related death, the committee recommend the quantum of compensation to be paid by the sponsor. The committee shall examine each report of death within a time period of 30 days of receiving the reports from the respective ethics Committee.

The Govt of India has made new rules relating to the the setting up of independent ethics committees to monitor ongoing drug trials. These Ethics committees has to be registered with the DCGI prior before the conduct of clinical drug trials. Apart from mandatory registration, the government has set specific parameters for forming ethics committees with a focus on avoiding conflicts of interests that members could be susceptible to and ensuring diversity in the membership profile members. For instance, the chairman of the committee must not be from the institute where the clinical trial is proposed to take place. All the members of the panel, which must include five representatives from medical sciences, would have to sign a declaration that they have no conflict of interests. The ethics committee would have to give their report on any injuries or death that may occur during the trial to the drug regulator within 21 days of the event.

With Supreme Court and Government implementing stricter regulations, Indian pharma companies can still reap the advantage of huge population, selecting only well equipped hospitals, trained doctors to conduct trials at low cost as per International guidelines. India Pharma company and Indian CROs, are already geared up to abide by the rules, for which they are streamlining their processes, SOPs, proper documentation of the Clinical trials phases, improvise their contracts, and compensations to bring the drug to market safely and in time.

Clinical trials and research will emerge as a major business in India in coming years because of improved reporting system, controls and enhanced compensations to volunteers in cases of trial-related deaths or injuries. The government has prescribed that the trial subject should be provided free medical management in case of an injury. The pharma company would have to submit a detailed report on the adverse event to the ethics committee within 10 days.

Though this shift has taken some time and delayed approvals from Govt which has led many pharma MNCs to shift their base for clinical trials, yet once the processes are in order resumption of good Quality Clinical work will not take much time.

However, the drug development landscape is markedly different today than it was a decade age. Basic science discoveries have piled up, waiting for a translational framework to get them tested fast over the clinical development cascade for reaching the physician’s desk as soon as possible.

The lack of standardization of regulations at International level, need for clinical trials in every isolated territory even for the products who do not have efficacy affected by genomic variation, and slow approvals from regulatory bodies are the main hurdles being faced.

The industry has reported a decline in Clinical Trials approvals in 2011, leaving the nation with a market share of 2.20 per cent. Between 2008-2009, the Indian Clinical Research market has registered a 9.60 per cent decline in revenues as against China which grew by 15.30 per cent. China, Korea and Singapore have started emerging as fierce competitors for conducting Clinical Trials after the decline in Clinical Trials in the US.

Expediting screening process, conducting NDAC and IND committees on more frequent intervals, more empowerment to DCGI officers and harmonization of regulatory needs internationally will definitely boost the morale of industry besides helping them to bring solution to tough diseases timely to the society.

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