Drugs of foreign origin need phase I data for concurrent clinical trials

Jayashree Padmini - New Delhi

THE Union Health Ministry has decided to maintain status quo with regard to concurrent phase I clinical trials in the country. Official sources said the formalities and rules will remain the same as given in draft Schedule Y. This decision, taken at a high level meeting last week, has put an end to apprehensions about trying untested drugs of foreign origin in the domestic population.

The Schedule Y draft states that for new drug substances discovered in countries other than India, phase one data from other country(ies) should be submitted along with the application. The data required include specific pharmacological effects, general pharmacological effects, pharmacokinetics, absorption, metabolism, excretion, pharmacodynamics and early measurement of drug activity.

After the phase one data generated outside India has been submitted to the licensing authority, permission may be granted to repeat phase one and to conduct phase two and subsequently, phase three trials concurrently with the global trials of those drugs, it stated.

For drugs discovered in the country, clinical trials are permitted here right from phase one. Phase one studies conducted on a limited number of healthy human beings aim to assess safety and tolerability with the initial administration of an investigational new drug into humans.

The expert committee under the health ministry including DCGI and experts from different quarters also assessed the feedback received on the draft Schedule Y before fine-tuning the document. Official sources informed that there would not be any major change from the draft apart from a few operational aspects. The upper limit of ethics committee will be removed so as to include additional experts as and when necessary, said the source. Further, the responsibilities of ethics committees would be clearly spelt out whereas, earlier in the draft, it was given only for the investigator and the sponsor.

The document will shortly be forwarded to the Health Ministry and is most likely to be notified by April this year, said official sources. This could be tabled in the Parliament when it resumes after the elections and if no objections are raised within a month, the document will automatically become part of the Drugs and Cosmetics Act.