The Union health ministry will soon amend rule 122A (2) and rule 122B (3) of Drugs and Cosmetics Rules to restrict the waiver of clinical trial in Indian population for approval of new drugs (which have already been approved outside) to national emergency, extreme urgency, epidemic and for orphan drugs for rare diseases.
Presently, there are provisions under rule 122A (2) and rule 122B (3) for waiver of local clinical trial in public interest. Schedule Y further provides that requirements of clinical trial may be abbreviated, deferred or omitted for drugs indicated in life threatening or serious diseases or diseases of relevance to Indian Health scenario.
The health ministry's decision to amend the D&C Rules in this regard comes following the acceptance of the Prof. Ranjit Roy Chaudhury expert committee recommendations by the ministry. In February this year, the ministry had constituted the Prof. Ranjit Roy Chaudhury expert committee to formulate policy and guidelines for approval of new drugs, clinical trials and banning of drugs.
The committee was constituted in pursuance of the averments made in the Action Taken Report submitted to the Department Related Parliamentary Standing Committee on Health and Family Welfare in response to the recommendations contained in the 59th Report of the said Committee on the functioning of Central Drugs Standard Control Organisation (CDSCO).
After several rounds of meetings, the committee recently submitted its recommendations to the ministry. The recommendations of the expert committee were discussed in a meeting with its members recently. During the meeting, clarifications on certain recommendations were obtained from the committee. After the meeting, the ministry in-principle accepted the recommendations of the committee.
In its rather lengthy report, the Prof. Ranjit Roy Chaudhury expert committee recommended that 'Waiver of Clinical Trial in Indian population for approval of new drugs, which have already been approved outside India, can be considered only in cases of national emergency, extreme urgency, epidemic and for orphan drugs for rare diseases and drugs indicated for conditions/diseases for which there is no therapy'.