The Central government is planning to enforce stringent regulations for improving standards for human clinical trials conducted for medical devices, Surinder Singh, Drug Controller General of India (DCGI), said.
The regulator, which is planning to allow first phase of human clinical trials soon, will make registration of ongoing clinical trials and clinical research organisations in the country mandatory. This is to bring in reliable and high quality standards for the conduct of trials in the country.
At present, clinical trial registrations are not mandatory and those who conduct trials can volunteer to register with the Indian Council of Medical Research (ICMR). It is estimated that the clinical trial industry in the country has a size of about $350 million with about 290 clinical research organisations. The industry is poised to be worth $1 billion within two years.
DCGI said the government was planning to mandate modern analytical tools such as analysis of data with LCMS, radio labelling. Other plans include insurance coverage and finger printing of volunteers to ensure safety and efficacy of data.
A group constituted by the Central Drug Standards Control Organisation(CDSCO), which includes officials of CDSCO, industry and academia, has been formed to lay down standards for clinical trials.
The government is also planning to strengthen the post-marketing surveillance of drugs to find adverse drug reactions (ADRs). At present, 24 peripheral, 5 regional and two zonal centres have reported over 10,000 ADRs and some of the suspected drugs have been sent for tests abroad.
DCGI said the government plans to bring in separate legislation for medical devices. At present, medical devices are classified as drugs and about 10 medical devices were notified two years ago with rules for licensing and marketing in the country.
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The department has started training officials with the support of the World Health Organisation (WHO) and new posts of 94 drug inspectors have been sanctioned. These inspectors will monitor the clinical trial and medical devices industry. At present CDSCO has 110 officials, though some posts are lying vacant.
DCGI said the government was also planning inspection of manufacturing sites abroad for allowing marketing of drugs in India.
He said the department would move to paperless e-governace within two years. Efforts are on to have digitalised interactive portal, which will have facilities such as online application for new drugs and online approval with digital signatures. The five zonal offices of CDSCO will be also networked, he said.