Apex committee on clinical trials to have greater say in waiving off requirement for local trials for foreign drugs

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The Apex Committee, set up by the Union health ministry to regulate and supervise the clinical trials, is going to be the final authority to extend waiver of local clinical trial requirement for approval of new drugs which have been approved in other countries.

The waiver would be granted only under certain criteria like national emergency, extreme urgency, epidemic and for orphan drugs for rare diseases and drugs indicated for conditions and diseases for which there is no therapy and will be vetted by the apex panel, according to the health ministry.

Sources said in case local clinical trial waiver is required for any other category, the matter should be brought before the committee for consideration along with the recommendations of the technical committee, another panel set up by the Ministry in accordance with the directions of the Supreme Court on clinical trials sector.

The move is in line with the recommendations by the Parliamentary panel and the expert committee headed by Ranjit Roy Chaudhury on clinical trials. The ministry had already taken the decision to allow waiver of local trials only under the above said conditions like national emergency, extreme urgency, epidemic and orphan drugs for rare diseases.

The matter was first discussed by the technical committee and then came to the apex committee, headed by the Secretary of the health ministry. The panel accepted the recommendations by the technical committee to further streamline the process for granting waiver of local trials.

According to the existing rules, for new drugs approved in other countries without local clinical trials in the country, phase III trials are required before granting the permission to manufacture and import of finished formulation of the new drug.

But, requirements of local clinical trials may be waived off or relaxed under certain conditions as per Drugs and Cosmetics Rules 122 A (2), 122 B (3) and clause of 1 (3) of Schedule Y. The licencing authority may in public interest decide to grant such permissions on the basis of data available from their countries. Further, the submission of requirements relating to animal toxicology data may also be modified or relaxed under same rules in case of new drugs approved and marketed for several years in other countries and adequate published evidence regarding safety of the drug is available.

The Parliamentary Standing Committee on Health in its 59th report had raised the issue and concerns about the manner in which the local trial requirement was waived off and the matter was also dragged to the Supreme Court. The Government, following this, set up the expert panel under Prof Chaudhury and decided to tighten the rules.

Source: PharmaBiz


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