Norms for clinical trials to weed out malpractices

the union minister for health c p thakur on friday released the guidelines on clinical trials for human beings at the inauguration of the 53rd indian pharmaceutical congress. the gcp, formulated by an expert committee and set up by central drugs standard control organisation in consultation with clinical experts, would ensure uniform quality of clinical research throughout the country and generate data for registration for new drugs before their use. dr thakur said the government plans to increase the outlay for medical research by four-fold in the next budget. according to the drug controller of india, ashwini kumar, the 'good clinical practices' would lay down specifications to ensure quality of clinical research, data to be generated, —in order to make it acceptable internationally — and audit of trials. the gcp would deter instances of unauthorised medical experiments such as the contraceptives trial in aiims, anti-cancer trials in thiruvananthapuram and gene therapy for cardiac disorders in noida. it would also trigger a boom in the business of clinical trials —inventions abroad would probably be tested here. to protect us from being turned into a nation of guinea pigs, the gcp would cover the human rights angle — patients on whom trials are carried out should give an ''informed'' consent, which means the consent form should be in the patient's language with details on possible risks and after-effects as well as a ''right to withdraw'' from the study. the study conducted and data maintained should be in such a format that it is verifiable. all the mechanisms adopted in the study, the various stages of therapy, and adverse reactions if any should be mandatorily recorded. not all countries have gcp in place, they have mostly adopted the who or international conference on harmonisation principles. with modern-day therapy demanding a higher degree of expertise, the indian pharmaceutical congress association which represents five associations is pressing for a degree in pharmacy as the basic qualification. most of the five lakh pharmacists in the country at present and the 28,000 to be added on at the end of this academic year are mere diploma holders. speaking to reporters on the eve of the congress, prof s k kulkarni, dean at the university institute of pharmaceutical sciences in chandigarh, said the government had to make an amendment in the rule 71 and 76 of the drugs and cosmetics rules to make graduation the minimum qualification.

Norms for clinical trials to weed out malpractices

THE UNION minister for health C P Thakur on Friday released the guidelines on clinical trials for human beings at the inauguration of the 53rd Indian Pharmaceutical Congress.

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