Introduction of new drugs without local trial is unscientific & risky as patients here have different anthropometry: Experts
Experts in the life-sciences industry are of the view that doing away with human studies for new drugs in India is unscientific and risky as patients here have different anthropometry. Clinical trials involving human subjects are a crucial step in the drug development process, as it assesses safety, efficacy, and potential adverse drug reactions of a new medication.
Because of the population variability, carrying out clinical trials with diverse people helps ensure that the drug’s performance is well understood across various demographic groups, they opine.
Experts were airing their views following a recent news report in the media in which OPPI (Organisation of Pharmaceutical Producers of India) demanded to the Drugs Controller General of India (DCGI) that India should allow introduction of new drugs simultaneously with their introduction in international market. Underlying this was the demand to scrap clinical trials of these new drugs in India on patients in India. Such a suggestion is highly unscientific as most other nations do not allow such introduction of medicines without clinical trials if not conducted in their country, pointed out experts who did not wish to be named.
Indian patients have entirely different anthropometry, have different dietary habits, and have a number of genetic characteristics that differ from western patients. Hence human studies provide insights into the effectiveness of a drug in treating specific conditions within the target population. This information is essential for regulatory authorities to make informed decisions on drug approvals, they added.
Considering these, the Indian Council of Medical Research (ICMR) has in the last decade come out with RDAs (Recommended Dietary Allowances) as so long those specified for westerners were being used. Doses decided based on phase I, phase II/III studies abroad would then be applied rather unscientific way on to patients in India. Such a thing can show different safety profiles apart from efficacy outcomes, experts said.
It is critical to consider regional differences and not to eliminate human studies but to ensure that these studies include diverse populations representative of the intended market. Therefore human studies are a fundamental and ethical aspect of drug development, providing valuable data on safety and efficacy assessments of new medications, they averred.
It is true that some companies are upset over the delays in getting approvals for clinical trials in India. An expert committee under Supreme Court has given guidelines for clinical trials of new drugs. CDSCO needs to find ways to hasten review and granting of permissions for clinical trials of new drugs keeping in mind and specifying clear requirements for informed consent and ethical aspects of the trials, said the experts.
India has demonstrated high capability to undertake good clinical trials. There is no reason why such process cannot be implemented with additional safety steps to avoid any glitches or ‘alleged exploitation’. Suggestion that drugs should be permitted without any trials in India just because of ‘alleged delay in trial approvals’ is like saying ‘no need for traffic signals because some may not be working’. Government needs to be careful while considering this suggestion of doing away of human studies for new drug in India, experts cautioned.
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