Herbal drug regulation and commercialization: an Indian industry perspective.

OBJECTIVES: To assess the constraints for Indian herbal drug industry with respect to manufacturing and commercialization of herbal medicines. METHODS: A questionnaire-based survey was conducted to obtain primary data on challenges faced during production, commercialization, and marketing approval for traditional or herbal drugs in India and abroad. Responses were collected from 150 companies by email, telephone, and in-person interviews from June 2009 to August 2010 and were analyzed to draw appropriate conclusions. RESULTS: The survey result showed that differing regulatory requirements and the limited market in foreign countries are the major hindrances for exporting. Standardization and quality control of raw materials and herbal formulations emerged as the major challenge for Indian herbal drug manufacturing firms. Insufficient regulatory guidelines, particularly guidelines for good manufacturing practices; nonimplementation of good agricultural and collection practices; and weak implementation of the Drugs and Cosmetics Act of 1940 are considered major drawbacks for the Indian herbal industry. CONCLUSIONS: Proper implementation of the Drugs and Cosmetics Act of 1940, development of more elaborate guidelines on quality control aspects, and development of marker-based standards are needed to produce safe and effective herbal medicines in India. Because evidence-based studies are becoming increasingly essential for establishing the safety and efficacy of herbal products in the domestic and export market, more focus should be placed on scientific and technological advancement in the field of herbal medicine. Regulatory harmonization becomes essential to mitigate the delays in commercialization across countries.

Herbal drug patenting in India: IP potential.

ETHNOPHARMACOLOGICAL RELEVANCE: Herbal drugs are gaining worldwide prominence due to their distinct advantages. Developing countries have started exploring the ethnopharmacological approach of drug discovery and have begun to file patents on herbal drugs. The expansion of R&D in Indian herbal research organizations and presence of manufacturing units at non-Indian sites is an indication of the capability to develop new products and processes. The present study attempts to identify innovations in the Indian herbal drug sector by analyzing the patenting trends in India, US and EU. METHODOLOGY: Based on key word and IPC based search at the IPO, USPTO, Esp@cenet and WIPO databases, patent applications and grant in herbal drugs by Indian applicants/assignees was collected for the last ten years (from 1st January 2001 to 31st October 2010). From this collection patents related to human therapeutic use only were selected. Analysis was performed to identify filing trends, major applicants/assignees, disease area and major plant species used for various treatments. RESULT: There is a gradual increase in patent filing through the years. In India, individual inventors have maximum applications and grants. CSIR, among research organizations and Hindustan Unilever, Avesthagen, Piramal Life Science, Sahajanand Biotech and Indus Biotech among the companies have the maximum granted patents in India, US and EU respectively. Diabetes, cancer and inflammatory disorders are the major areas for patenting in India and abroad. Recent patents are on new herbal formulations for treatment of AIDS, hepatitis, skin disorders and gastrointestinal disorders. CONCLUSION: A majority of the herbal patents applications and grants in India are with individual inventors. Claim analysis indicates that these patents include novel multi-herb compositions with synergistic action. Indian research organizations are more active than companies in filing for patents. CSIR has maximum numbers of applications not only in India but also in the US and EU. Patents by research organizations and herbal companies are on development of new processes for active compound isolation and standardization of such components in addition to new compositions for therapeutic use. Pharmaceutical companies such as Ranbaxy, Lupin and Panacea Biotec are increasingly patenting on herbal drugs. There is increased patenting activity related to diabetes, cancer, cardiovascular diseases, asthma and arthritis in India and abroad.

Recombinant drug development, regulation, and commercialization: an Indian industry perspective.

INTRODUCTION: The Indian biopharmaceutical sector comprises nearly 40 companies that manufacture and/or market 14 recombinant drugs that account for nearly 50 products. Among these, 22 companies have manufacturing facilities in India. OBJECTIVE: The aim of the present study was to analyze the patenting trends, commercialization, and regulatory system for biopharmaceuticals in India. METHODS: Representatives from 19 such biopharmaceutical companies were interviewed on aspects related to regulatory compliance, manufacturing, commercialization, and innovation in order to understand the challenges faced by them in the current regulatory and patent system. RESULTS: The study revealed that 94% of the companies have filed patents and 52% are developing new biologic entities in areas such as diabetes mellitus, cancer, and congestive heart diseases. Forty-two percent of the companies consider delays in regulatory approval to be a major constraint for biopharmaceutical industry development. Almost all are of the opinion that uniform guidelines across countries would help to prevent delays in the commercialization of products. CONCLUSION: A high proportion of representatives of the biopharmaceutical industry in India identified that elaboration of regulatory guidelines, defined submission requirements, and drug approval timelines are vital to the growth of the biopharmaceutical industry.

Herbal drugs: standards and regulation.

The use of herbal drugs for the prevention and treatment of various health ailments has been in practice from time immemorial. Generally it is believed that the risk associated with herbal drugs is very less, but reports on serious reactions are indicating to the need for development of effective marker systems for isolation and identification of the individual components. Standards for herbal drugs are being developed worldwide but as yet there is no common consensus as to how these should be adopted. Standardization, stability and quality control for herbal drugs are feasible, but difficult to accomplish. Further, the regulation of these drugs is not uniform across countries. There are variations in the methods used across medicine systems and countries in achieving stability and quality control. The present study attempts to identify the evolution of technical standards in manufacturing and the regulatory guideline development for commercialization of herbal drugs.

Manufacturing of biodrugs: need for harmonization in regulatory standards.

Biodrugs (biologics) are much more complex than chemically synthesized drugs because of their structural heterogeneity and interactions within a given biologic system. The manufacturing process in the biodrug industry varies with each type of molecule and is far more elaborate and stringent due to the use of living organisms and complex substrates. Product purity and altered structural characteristics leading to potential immunogenicity have often been of concern when establishing quality and safety in the use of biodrugs. Regulatory compliance in manufacturing and commercialization of biodrugs involves quality control, quality assurance, and batch documentation. Many factors such as host cell development, cell bank establishment, cell culture, protein production, purification, analysis, formulation, storage, and handling are critical for ensuring the purity, activity, and safety of the finished product. Good Manufacturing Practice (GMP) for biodrugs has been developed in certain regions such as the EU, US, and Japan. Due to differences in manufacturing methods and systems, product-specific GMP guidelines are evolving. In general, there are variations in GMP guidelines between countries, which lead to difficulty for the manufacturers in conforming to different standards, thus entailing delays in the commercialization of biodrugs. There is a need to develop a unified regulatory guideline for biodrug manufacturing across various countries, which would be helpful in the marketing of products and trade. This review deals with the comparative framework and analysis of GMP regulation of biodrugs.