Indian Society of Clinical Research (ISCR) has urged the central drug control authorities to allow state drugs control departments to monitor the clinical trials conducted its region. While approval for human studies comes under the purview of the Drugs Controller General of India office, the state drugs control department across the country needs to be roped in to keep a close watch on the same.
From clinical trial site inspection to overseeing patient recruitment and proper conduct of these human studies happening in each state need to come under the purview of the local drugs control department and it would be easy to scrutinize every step. However, this call for extensive training of the drug inspectors associated in the supervision of clinical trials. The training imparted should not be just from CDSCO but from global regulatory agencies like the US FDA, EMA and MHRA among others who need to instruct and arm them with the skills in clinical trial inspections, Suneela Thatte, president, ISCR told Pharmabiz in an interaction.
“We see the involvement of the state drugs control departments as a critical component during the clinical trials. Therefore, a coordinated effort from the pharma and biotech industry, academia and regulatory authorities would provide the required dimension in the training of the drug inspectors,” said Thatte who was in Bengaluru in connection with the DIA 8th annual event.
Commenting on the current scene, ISCR president said that there is no need for new regulations to be brought in the area of clinical trials in India. The current norms like the audio visual and the compensation for injury just need to have a bit more clarity but the remaining could be the same. The reality is that as much as clinical research organizations (CROs) are impacted, the academic research at centres including the NIMHANS are now seen to be retarded on the prospect of drug breakthroughs for patients.
“While CROs have breathed a sigh of relief after the Supreme Court permitting five clinical trials this year after proper mechanism and procedures are in place to ensure patient safety with confidential audio visual recording of patient consent, ISCR too views this order as a positive move,” she said.
Stalling of human studies since January end, is seen as a major deterrent of not just growth of the CROs but for patients also as they are not able to access latest therapies. India accounts for 20 per cent of the global disease burden spanning from life style ailments to infectious diseases and gene-related disorders. Patients are keen to participate in clinical trials only to find relief from serious conditions. From a clinician perspective too, it is an opportunity lost to participate in a global study. Therefore the Ministry of Health needs to be confident that much of the recent regulations are a step in the right direction. The Supreme Court permitting the government to clear five global clinical trials and re-examine the 157 global clinical trials including new chemical entities by the Technical and Apex Committee indicates the confidence reposed by the Bench of Justice, noted Thatte.
Now coming to the audio visual recording, the new norms should ensure that only the consent to participating in a clinical trial by a patient should be captured to maintain his privacy and dignity, said Dr Thatte.
Source:Pharmabiz
From clinical trial site inspection to overseeing patient recruitment and proper conduct of these human studies happening in each state need to come under the purview of the local drugs control department and it would be easy to scrutinize every step. However, this call for extensive training of the drug inspectors associated in the supervision of clinical trials. The training imparted should not be just from CDSCO but from global regulatory agencies like the US FDA, EMA and MHRA among others who need to instruct and arm them with the skills in clinical trial inspections, Suneela Thatte, president, ISCR told Pharmabiz in an interaction.
“We see the involvement of the state drugs control departments as a critical component during the clinical trials. Therefore, a coordinated effort from the pharma and biotech industry, academia and regulatory authorities would provide the required dimension in the training of the drug inspectors,” said Thatte who was in Bengaluru in connection with the DIA 8th annual event.
Commenting on the current scene, ISCR president said that there is no need for new regulations to be brought in the area of clinical trials in India. The current norms like the audio visual and the compensation for injury just need to have a bit more clarity but the remaining could be the same. The reality is that as much as clinical research organizations (CROs) are impacted, the academic research at centres including the NIMHANS are now seen to be retarded on the prospect of drug breakthroughs for patients.
“While CROs have breathed a sigh of relief after the Supreme Court permitting five clinical trials this year after proper mechanism and procedures are in place to ensure patient safety with confidential audio visual recording of patient consent, ISCR too views this order as a positive move,” she said.
Stalling of human studies since January end, is seen as a major deterrent of not just growth of the CROs but for patients also as they are not able to access latest therapies. India accounts for 20 per cent of the global disease burden spanning from life style ailments to infectious diseases and gene-related disorders. Patients are keen to participate in clinical trials only to find relief from serious conditions. From a clinician perspective too, it is an opportunity lost to participate in a global study. Therefore the Ministry of Health needs to be confident that much of the recent regulations are a step in the right direction. The Supreme Court permitting the government to clear five global clinical trials and re-examine the 157 global clinical trials including new chemical entities by the Technical and Apex Committee indicates the confidence reposed by the Bench of Justice, noted Thatte.
Now coming to the audio visual recording, the new norms should ensure that only the consent to participating in a clinical trial by a patient should be captured to maintain his privacy and dignity, said Dr Thatte.
Source:Pharmabiz
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