-The Indian Express
India may not be a testing hub for Big Pharma. But informed consent must be non-negotiable
Figures released by the World Health Organisation, which show that 10 Indian subjects of clinical field trials die every week, have rekindled concerns that this country has become a testing hub for Big Pharma. Ironically, the same figures deflate this persistent fear, revealing that only 1.5 per cent of global trials have been held in India. The ministry of health and family welfare has further clarified that the cause of death must be investigated to determine if pharmaceutical testing contributed to mortality. But public debate must take note of the growing evidence on a related problem. In February, the Supreme Court issued notices against the ministry and the Medical Council of India in response to a PIL alleging collusion between pharma companies and doctors in Indore. They were allegedly paid commissions to enrol patients in tests that claimed 32 lives. The Economic Offences Wing of the Madhya Pradesh government also tabled a report naming six doctors.
Statistics are secondary here. Even a single case of unethical testing, where the rules of the doctor-patient relationship have been broken to the material benefit of practitioners or corporates, should be read as a significant finding. And such cases may occur because getting patients to consent to drug testing is relatively easy in India. Thanks to illiteracy, poverty, poor health awareness and lax oversight, it is possible to acquire test patients quite fast. Speed makes a huge financial difference to pharma companies, which can bring new drugs to market more quickly. And if problems arise, the risk of successful litigation is low.
Regulation should be equally easy. Regulators only need to check if the consent given by patients is genuinely informed. The ministry and the MCI cannot claim that they are unable to do this. Serious punitive measures must be instituted against erring doctors and corporations, not paltry fines. This is all it will take to make the problem vanish forever.