The central government is planning to enforce stringent regulations for human clinical trials and medical devices, the drugs controller general of India (DCGI) has said.
The regulator, which is planning to allow first phase of human clinical trials soon, will make registration of clinical research organisations and ongoing clinical trials mandatory. This is to ensure high quality standards for these trials.
At present, clinical trial registration is not mandatory and those who conduct trials can volunteer to register the same with the Indian Council of Medical Research (ICMR). The domestic clinical trial industry is estimated to be worth $350 million with about 290 clinical research organisations. The industry is poised to grow to $1 billion in two years.
Surinder Singh, the drugs controller general, said the government was planning to mandate modern analytical tools such as analysis of data with 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 CDSCO officials and representatives of industry and academia has been formed to lay down standards for approval of 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, five regional and two zonal centres have reported over 10,000 ADRs and some of the suspected drugs have been sent for tests abroad.
The DCGI said the government planned to bring a separate legislation for medical devices. At present, medical devices are classified as drugs.
The department has started training officials with the support of the World Health Organization (WHO) while the government has sanctioned 94 new posts of drug inspectors. These inspectors will monitor the clinical trial and medical devices industry. At present, CDSCO has 110 officials, though some posts are lying vacant.
Singh said the government was also planning to inspect manufacturing sites abroad for allowing marketing of drugs in India. He said the CDSCO was trying to have a 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 the CDSCO would be networked, the DCGI added.
