THIRUVANANTHAPURAM: Move to test drugs on patients in government hospitals in the state. The move is to try new medicines including foreign ones. It will be tested in medical colleges, district and general hospitals.

The trial is underpinned by the Health Research Policy drawn up by the Higher Education Council. However, experts allege that the state cannot conduct drug testing under central control and that there is a move to provide data for testing conducted secretly with foreign help in private hospitals.

The government believes that the trial of new drugs can bring about major changes in the field of treatment. Patient information will be provided to researchers with confidentiality assured. Anonymized birth and death information and disease data from the Department of Health and Insurance will be provided. Data will be shared between government agencies and with national, international, autonomous and private organizations. Funds for research can also be collected from abroad.

The Higher Education Advisory Committee chaired by the Chief Minister has approved the policy. Cabinet approval is required next. Drug testing is being done at Sree Chitra Institute, Rajiv Gandhi Center for Biotechnology and RCC with central approval.

Drug testing is not child's play

• The trial should be conducted under the strict guidelines of the Central Drugs Standard Control Organization and the Indian Council for Medical Research.
• An ethics committee should be formed with the approval of ICMR and a strict check should be done at each stage. This cannot be done by the state by making policy
• Transfer of disease information and birth and death data is restricted. The rule is that sensitive information should not be given outside the country. Anonymizing data is not practical

Experiment in Kerala

• The banned NDGN-M4 (for oral cancer) was allegedly tested at RCC with the help of Johns Hopkins University in the US. There was no central approval. RCC was whitewashed in the investigation
• It is reported that 10 people died in Kochi hospital, 2 people died in Kozhikode hospital and 3 people died in another hospital in Kochi when an American medicine was tried. It is alleged that 3 people died during drug testing by a Swiss company at a research centre in Thiruvananthapuram owned by 3 doctors.
• PNB Vesper Company, Kochi was given permission by the Drug Controller to test the drug PNB-001 in Covid patients.

7 years, 2644 deaths

• The restriction came after 2644 people died during drug testing in the country from 2005-12. This is the figure informed by the Centre to the Supreme Court
• 11,972 people had serious side effects. Out of 475 drugs, only 17 got marketing approval.

Drug tests are required. However, the central norms must be strictly adhered to

-Dr. Mohanan Kunnummal

Vice Chancellor, University of Health