The Madhya Pradesh government has fined 12 doctors Rs. 5,000 each for conducting drug trials on children and mentally challenged persons, even as the Opposition Congress termed the fine an “eyewash” and a “joke” and demanded a CBI probe into the matter.
Besides fining the doctors, the government issued instructions for banning new drug/clinical trials with retrospective effect from October 25, 2010 in medical colleges of the State and hospitals attached to them.
The doctors were fined for not maintaining records of tests and treatment and failure to provide requisite details to the Chief Medical and Health Officer under the Madhya Pradesh Nursing Home and Clinical Establishment (Registration and Licence) Act.
CBI enquiry demanded
The Congress criticised the State government for levying a meagre fine for “such a grave, inhuman crime” and accused it of selling out to multinational pharmaceutical companies.
“The lives of the poor patients who were victimised in the name of drug trials is just Rs. 5,000? We demand a CBI inquiry in the matter,” said Leader of the Opposition in the Assembly Ajay Singh.
A State government communication informed that “while there was no provision in Schedule ‘Y' of the Drugs and Cosmetic Rules 1945 for powers to States to monitor/regulate drug/clinical trials,” instructions were issued to the Madhya Pradesh Health Commissioner and the Chief Medical and Health Officer, Indore to get registered with the Clinical Trial Registry of India under the Central Drug Controller and then seek drug trial-related information from 38 doctors of the Public Health and the Family Welfare Department.
Earlier, the doctors refused to provide details of drug/vaccine trials to the government citing provisions of the Drug and Cosmetic Rules 1945.
The Chief Medical and Health Officer, Indore, also sought details in this connection from the president of the Nursing Home Association and the president of the Indian Medical Association, Indore.
The State government expressed its inability to conduct any detailed investigation involving the patient/subjects under trials, citing legal provisions that protect the identity of trial subjects.
