Indian Drug Manufacturers' Association (IDMA) has urged the centre to clarify the term 'clinical trial' mentioned in the proposed Drugs and Cosmetics (Amendment) Bill, 2007 under which Central Drugs Authority of India is being planned.

According to the IDMA sources, the definition of the term 'clinical trial' under the Section 2 (aaii) was substantially different from the existing definition of clinical trials under Rule 122DAA of the Drugs and Cosmetics Rules, 1945. The proposed definition covers not only drugs but also cosmetics.

According to a memorandum submitted recently by IDMA to the Centre, the IDMA said, "the definition of clinical trails is not in line with Rule 122 (DAA) and Schedule Y. We suggest that the word 'any drug' used in the definition of clinical trial should be substituted by `investigational new drugs'. Such change is necessary to harmonize the requirement for clinical trials with the international guidelines on good clinical practices".

The proposed Section 5N of the proposed bill would bring all post marketing trials and academic research to a complete halt. The surveillance studies generate useful data on local population for drugs that are not tested extensively before marketing in India, the association sources said.

Commenting over the confirmatory trials, the IDMA claimed that these trials were conducted on marketed products so as to confirm its efficacy & safety from other relevant parameters. "Since these products are already marketed, there is no need to seek permission to conduct such clinical trials. Confirmatory trials that are performed before actual launch can also be exempted," the memorandum said.

IDMA said that the multiple trials, which were extension of the originally performed trials, may be exempted from the requirement of the permission by the CDA. The bill proposed to cover clinical trials for cosmetics also. However, the requirement of cosmetics registration was totally different from drugs and therefore the clinical evaluation of cosmetics would not be the same as required for drugs, according to the IDMA.

"It is therefore suggested that at this stage, the proposal to cover the clinical trials of cosmetics should be dropped. For this purpose, the word "Cosmetics" used in the definition of clinical trials under section 2 (aaii) and used in Section 5N should be omitted,'' it said.

It also said that the punishments clause under Section 5(O) should make a distinction between clinical trials conducted strictly in accordance with the good clinical practices and in compliance with all ethical requirements without obtaining permission and unauthorized clinical trials causing adverse effect or grievous hurt to the volunteers.