Panel Moots Streamlining Of EPA, Drugs And Cosmetics Act

1-4 September, 2006 Pragati Maidan, New Delhi, India

Panel Moots Streamlining Of EPA, Drugs And Cosmetics Act

Pending setting up of the proposed statutory Indian Biotechnology Regulatory Authority (IBRA), the Mashelkar panel on recombinant pharma has suggested streaming of the existing regulatory system under Rule 1989 of Environment Protection Act (EPA) and Drugs and Cosmetics Act and Rules.

The panel headed by the director-general of the Council of Scientific and Industrial Research (CSIR), Dr. R A Mashelkar, noted that imports of living modified organisms (LMOs), otherwise called genetically modified organisms (GMOs) as well as that of micro-organisms for RandD work, has been made cumbersome with the new Plant Quarantine Order issued by the Union agriculture ministry. This has hampered the RandD, Quality control and manufacturing activities in the pharma sector. In a draft report slated for discussions on September 5, the panel has sought to curtail the powers of the existing apes regulator, Genetic Engineering Approval Committee (GEAC). It has also noted inadequate information being presented by the applicant companies to the regulatory authority for obtaining clearances and has, therefore, suggested a format for disclosure. It also noted that opportunity to an applicant to present proposal to the regulator is not a common practice.

The report said that environment impact of the GMOs per se and the products thereof, have not been clearly identified in the pharma sector. There is no mechanism for examination of post marketing surveillance of recombinant pharma products and feedback on product efficacy and environment safety. On risk assessment and management of microorganisms, bio safety and risk categories as suggested by WHO or other international standards or guidelines are not fully implemented.

Unlike the MS Swaminathan panel, which had representatives from two associations of seed companies, the Mashelkar panel has representatives from apex industry organisations like Federation of Indian Chambers of Commerce and Industry (FICCI), Confederation of Indian Industries (CII) and Associated Chambers of Commerce and Industry (Assocham).

Expressing the industry concern, the draft report of the Mashelkar panel said that multiple approval system has led to cumbersome and lengthy approval process. Regulatory objectives of different agencies in the regulatory chain are sometimes overlapping. Regulatory committees lack expertise in some important aspects and frequencies of meetings of these committees are irregular and inadequate.

The draft report, therefore, called for defining the roles of each regulatory body and specifying the time limit for them and clearly enumerating stepwise procedures in bio safety regulations.

The report further said that the Drugs Controller General of India (DCGI) and not the GEAC should accord approval for conduct of human clinical trials. At present the GEAC, as the apex regulator, accords approval for phase III human clinical trials. The Review Committee on Genetic Manipulation (RCGM) under the promoter agency, department of biotechnology, should continue to examine the protocols and pre-clinical data submitted by applicant and forward it to DGCI. RCGM based on the report of the company`s Institutional Bio Safety Committee (IBSC) should inform to GEAC about the containment facilities installed for handling LMOs in research and production. However, approval by GEAC would be required for the containment facility set up for manufacturing pharma products utilising more that 20-litre fermentation capacity.

The Recombinant Drugs Advisory Committee (RADC) should approve the protocol for conducting all the three phases of human clinical trials by DCGI. After human clinical trials, DCGI would either approve or reject the product. DCGI should examine the data on toxicity, allergenicity and other quality control test through RDAC. When an LMO per se is to be used as a product, GEAC is also to approve phase III human clinical trials based on risk-benefit analysis and also approve environment release. GEAC will confine its regulatory role in terms of product approvals only if the products are LMOs and not for microorganisms. GEAC will not be required to approve import of recombinant pharma products, which do not contain LMOs.

Date: 26-Oct-2004

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