Even as the Parliamentary Standing Committee is examining the Drugs and Cosmetics (Amendment) Bill, 2013 that seeks to establish the Central Drugs Administration (CDA), experts in the pharma industry have recommended for the inclusion of a South African model monitoring mechanism in the proposed CDA Bill for continuous assessment of functioning of Ethics Committees through an accrediting body such as Research Ethics Council (REC).
A monitoring mechanism needs to be evolved for continuous assessment of functioning of Ethics Committee through an accrediting body such as Research Ethics Council (REC). For example, South African National Health Research Ethics Council, NHREC, accredits and oversees research Ethics Committees at universities and other institutions, recommended PD Sheth, an expert in the industry.
In his submission to the committee, Sheth recommended that clinical trial cannot be abbreviated until it fulfills scientific and statistical requirements specifically for biologicals. Clinical trials should not be abbreviated, relaxed or omitted for biosimilars. In the composition of ethics committee the term 'medical field' should be enhanced to 'medical and pharmaceutical sciences'.
Office of the DCGI should register person, sponsor, clinical research organisation or any other organisation or investigator conducting a clinical trial or his agent through electronic system and each should be provided with the unique identification code. This will help office of the DCGI in tracking, tracing and monitoring all firms. Office of the DCGI may charge the industry for this initiative and the revenue can be utilized for up-gradation and continuous improvement, recommends Sheth, who is the vice-president, International Pharmaceutical Federation, The Hague.
Sheth, who is also the past president of Indian Pharmaceutical Association (IPA), recommended to the committee that in order to demonstrate therapeutic interchangeability, the Generic formulations of drugs approved in other countries must scientifically exhibit Bioequivalence to the Innovator product. Such biostudies carried out in human subjects tend to encompassing phenomenal expenditure of resources.
As major share of product development cost is on biostudies, local pharma industry should not be burdened with unnecessary BA/BE studies through well defined Biowaivers. Biopharmaceutical Classification System (BCS) based on solubility and permeability characteristics classify drug molecules into four categories. However, BCS has very limited use mainly for conventional/ immediate release oral products which do not belong to narrow therapeutic index/narrow therapeutic range/ critical dose drugs.
Organize separate cadre of specialist officers for drugs, biologicals and devices. Specialized drug control officers should be trained in Clinical Research inspections. Training programmes should be designed for every position based on nature of job and role undertaken by the officer. Competency assessment of regulatory workforce should also be carried out.
Thorough subjective assessment of clinical trials should be carried out as done by International Regulatory Authorities. Inspection closure notification must be provided to the inspected firm for the feedback.
Central drug authority should prepare a list out of its ongoing inspection of clinical trial sites and facilities and a public list of debarment of clinical trial sites and/or investigators should be prepared, he further recommends.