The drug control administration is gearing up to lay down stringent guidelines for strict monitoring of the clinical trials in the country on the lines of developed countries like US and Canada. The administration will adopt the latest tools and parameters existing in the developed countries in this regard.
Within a couple of months, a comprehensive system will be in place to regulate and monitor all the ongoing trials, an area so far not given enough attention by the authorities. A panel of three officials including drug inspector, pharmacologist and clinical trials expert will conduct surprise inspections on the sites of trials.
"Depending on the inspections on all aspects from infrastructure, skills of technicians, drugs to logistics and informed consents taken from the volunteers, we will be able to withdraw, suspend or hold back the permissions to the trials,'' DCGI Dr Surinder Singh told Pharmabiz.
With a view to equip the officials of the CDSCO for the task of monitoring the trials, two workshops have been already held by the WHO and US FDA experts recently. As many as 20 senior officials from different zones and academics were given hands-on training in the first stage, as part of putting up a fool-proof system in place, latest by December.
The trainers will then pass on the skills to junior officials in different zones and another round of workshops will be held with the feedback and suggestions. The WHO is funding the entire programme. A workshop was first held last week by the officials from Health Canada and another four-day workshop by US FDA officials just concluded on Friday. The US FDA officials also assessed the trials going on in a hospital in Delhi to get the first-hand information on the state of affairs in the area and recommend suggestions to the system.
The administration is also planning to make mandatory the registration of trials in the Clinical Registry being administered by the ICMR. Now it is done on a voluntary basis. Besides, the DCGI is also planning to get the CROs registered compulsorily after laying down the guidelines for them.
The monitoring of clinical trials has been an area of concern in the country. The recent reports of deaths of 49 babies in All India Institute of Medical Sciences, Delhi have once again emphasised the need of strict monitoring. Reports said there are at least 600 trials going on in different sites.
The series of workshops and interactions, including the familiarisation of Indian officials with the systems in developed countries, is aimed at making the CDSCO officials competent to monitor the trials. The entire modalities in this regard will be worked out within a couple of months.