The Indian pharmaceutical industry needs to introduce cGMP concepts in developmental pharmaceuticals and clinical batches. It should focus on more effective BE/BA studies on their formulations to improve efficacy of drugs, feels Dr M Venkateswarlu, Deputy Drugs Controller and Chairman, Regulatory Affairs Division, Indian Pharmaceutical Association.

The industry is lacking behind when it comes to quality assurance in developmental pharmaceuticals. They need to define the role of QA in R&D and the documentation required for R&D, he said.

Addressing a workshop on "Quality Assurance and Compliance in Pharmaceuticals", organized by South East Asian FIP-WHO Forum of Pharmaceutical Associations (SEARPharm Forum) here on June 9, he opined that Indian companies are still at a primitive stage when it comes to the documentation / data generation at the development pharmaceutical stage and suggested a better understanding of current GMP requirements.

"There is a need to define the role of QA in R&D, the documentation required for R&D. The optimization, standardization, stability studies and validation have to be carried out on R&D batches before commercial batches are produced. The concepts of International Conference on Harmonization from R&D to commercial production and presentation of data as per the requirements of CTD need to be properly understood," he said.

He was of the opinion that the companies need to understand the concept of bio batches, and importance of GMP in production of clinical trial batches as well as the need for co-relating in-vitro and in-vivo testing.

Listing out the areas requiring improvement, he wanted the industry to recognize the importance of vendor qualification and vendor audits as part of GMP requirements, not only in the case of bulk drugs, but also in all other materials going into the production and packing of drug substances and drug product such as container, closures, excipients etc.

He felt that the stability studies usually do not address the transit stress studies on the stability of the product and wanted a system to recall few batches to the factory and evaluated. Same was with the case of studying field samples, stored at varying conditions.

Suggestions of improvement in areas like training, documentation, gowning procedure, federal system etc were also made.

Dr Venkateswarlu was all praise for the industry for having created adequate number of state of the art facilities for various APIs and categories of formulations meeting global standards.