Owing to improved reporting system and enhanced compensations to volunteers in cases of trial-related deaths or injuries, clinical trials and research will bounce back as a major business in India in the near future despite the hiccups being faced today opines Dr. Manu Chaudhary, joint managing director, Venus Remedies Ltd.
“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 which will help to improve the overall industry scenario”, Dr. Chaudhary told Pharmabiz.
Since the government is now insisting that a 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 directional shift has taken some time and delayed approvals from government has led many pharma MNCs to shift their base for clinical trials to other countries, once the processes are in order, there will be a flurry of good quality clinical work in India ,” Dr. Chaudhary added.
With Supreme Court (SC) and the Union 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, said Dr. Chaudhary.
Indian pharma companies and domestic clinical research organizations (CROs) are gearing up to abide by the rules, for which they are streamlining their processes, standard operating procedures (SOPs), proper documentation of the clinical trials phases, improvise their contracts, and compensations to bring the drug to market safely and in time, she added.
Venus Medicine Research Centre (VMRC) located at Baddi, Himachal Pradesh has been conducting clinical trials for all its in-house patented research products. “We select reputed CROs with experience of handling trials in accordance to US FDA and the sites are selected based on the international audits undertaken at these facilities. Currently, we are pursuing four Phase III trials, five post marketing surveillance studies, two Phase II studies and a few Phase IV studies. VMRC does not foresee any challenge in compliance with revised regulatory norms,” she said.
“Our facility has the required infrastructure to handle and initiate all the stages of clinical trials. It has the capacity to generate and communicate data and provide information to patients, clinicians and support groups. The team of clinical research professionals are known to execute well designed clinical studies which are strictly compliant with Good Clinical Practice (GCP) in India and internationally, said Dr. Chaudhary.
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 recommends 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.
Further, there are new rules relating to the setting up of independent ethics committees(IECs) to monitor ongoing drug trials. These ethics committees have to be registered with the Drugs Controller General of India (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 conflict 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.
“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, have all made India suitable for clinical trials.
“The drug development landscape is markedly different today than it was a decade ago.
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,” said Dr. Chaudhary.
The lack of standardization of regulations at international level, need for clinical trials in every isolated territory even for the products which 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 of such human studies in the US.
Expediting screening process, conducting New Drugs Advisory Committee (NDAC) and Investigational New drug (IND) committees at increased 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, said Dr. Chaudhary.