Hyderabad: Medical experts are strongly objecting to the introduction of new drugs to the market without clinical trials being conducted on Indian patients. They say that it could lead to adverse drug reactions and secondary illnesses, and in some cases, it could also prove fatal.
The Union Health Ministry is contemplating permitting the introduction of new drugs for the treatment of diabetes and cancer, based solely on the results of treatment regimes in developed countries.
However, doctors are not in agreement with the employment of this strategy. “These methods are being employed to bring in effective drugs quickly; but this shortcut has a flip side — the compatibility with Indian patients will not be known. Clinical trials give us an idea of the dosage of the drug to be prescribed for Indian patients. They also produce records of the various possible adverse drug reactions,” said a senior doctor.
Dr Ashok Kumar, a consultant surgeon, said, “In the case of cancer treatment, it is important to verify how the drug reacts on Indians, as our physiology is different from that of people in developed countries. Before introducing drugs to the masses, their adverse reactions have to be assessed.” At present, the introduction of a new drug in India takes at least seven years. The government is looking for ways to reduce this time, to make drugs available to patients at the earliest.
Dr K.P. Reddy, a senior consultant who has patients undergoing clinical trials, said, “The waiver for clinical trials must be on a case-to-case basis. For lifestyle disorders such as cardiovascular diseases and diabetes, drugs can’t be introduced without clinical trials. But for infectious diseases such as tuberculosis, typhoid, malaria and hepatitis, that option to skip trials can be available.”Doctors involved in the administration of clinical trials say that drug surveillance data must be collected for a minimum of three months before the introduction of a drug to the open market.
