Turning down the proposal to redefine the term of 'clinical trials' to bring medical devices and cosmetics also under its purview along with new drugs, the Parliamentary Standing Committee on Health and Family Welfare has recommended a separate chapter for medical devices in the Drugs and Cosmetics (Amendment) Bill, 2007.

After examining the bill, the panel headed by Amar Singh in its recent report tabled in the Parliament however favoured bringing in Ayurvedic, Siddha and Unani (ASU) drugs under the purview of definition of clinical trials. It also suggested replacement of words in the act 'any drug' with 'any new drug' to bring in more clarity with regard the definition.

After analysing the opinion of the stakeholders, the committee is of the view that even though ASU drugs are formulated by methods different from that used for modern allopathic drugs, the chances of harm that a drug may likely cause are similar and cannot be ruled out. The committee would like to point out that definition of drug as given in the Act is applicable to both allopathic and ASU drugs. The committee therefore opines that ASU drugs should not be excluded from the scope of definition of clinical trial of drugs, the report said.

But the committee backed the contention of the cosmetic industry that physiological and therapeutic impact of drugs and cosmetics on human body is completely different. "Therefore, there is a need to separate trials of cosmetics from drugs so far as the case of ascertaining their safety and efficacy is concerned," the report said, while calling for trials for dermatological safety studies for cosmetics separately in the lines of the trials done into drugs. It also wanted modification of the Bill to include this.

While dwelling longer on the medical devices topic, the panel felt that there should be a different definition for medical devices, because of its distinct nature and functions from that of drugs. It recommended a separate definition consistent with the international standards. "The committee recommends that suitable modifications may be made in the Act with a separate chapter covering all the related aspects of regulation of medical devices. The panel also strongly feels that a dedicated division as recommended by the Mashelkar Committee may be set up to deal with regulation, licencing, surveillance and monitoring of uniform implementation of the laws on medical devices," the report said.

The panel felt that the current system was inadequate in regulating certification, quality assurance and post marketing surveillance of both imported and locally made medical devices. It also expressed displeasure on the impasse over a proposed bill on medical devices by the Department of Science and Technology. "The committee fails to understand the circumstances leading to such an initiative by the DST with the nodal ministry obviously being taken unaware. The committee can only hope that this issue is resolved at the earliest," the report added.