Abstract

REGULATORY REQUIREMENTS FOR MANUFACTURING AND APPROVAL OF HERBAL PRODUCTS IN INDIA AND G-8 COUNTRIES

Y. Ratna Sindhu* and Sunkara Lakshmi Prasanna

ABSTRACT

In this study an attempt has been made to delve in the status of Herbal Regulations in G-8 Countries and to develop a strategy for initiating harmonization of Herbal Regulations in G-8 Countries. Further, recommendations are provided to strengthen the existing regulatory mechanism of Herbals in India. Though the regulatory harmonization of herbals is found to be an extraordinary challenge, it is today’s crying need to tackle the quality issues globally, as the survey report proposes in the study. The survey also exposed the fact that the share of the Patent and Proprietary ASU drugs for export purposes are negligible compared to domestic market. Difficulty in approval process, difference in regulation, lack of proper guidance and information are some of the reasons as reported by the participants. In order to promote export of ASU and herbal drugs from India, support of Pharmexcil is inevitable and its accessibility shall be made easier to industries through continuous awareness campaign. Irrespective of the traditional history, all herbal drugs shall be tested for its safety and efficacy using
most modern analytical techniques to enhance reliability among users in international market. Apart from these, mutual acceptance of Pharmacopeia of the countries and mutual recognition of drug registration processes are yet to come up under the regulatory decision. The study proposes, to have a uniform regulatory framework, infrastructure development and technology application for e-governance in all Indian states for uniform implementation of law to culminate the issues such as spurious, adulterated and substandard quality drugs. The strength of enforcement wing in Indian States shall also be made in proportionate to the number of manufacturing units functioning, based on scientific and statistical study report, as it shows non-uniformity in regulatory strength. The law must be sharpened with implementation of Good Agricultural and Cultivation Practices, Good Storage Practices and Good Distribution Practices so as to maintain the quality of the drug at each point, starting from the bottom level and until reaching the end user.

Keywords: Herbal, traditional, ASU, Phytopharmaceutical drugs, harmonization, pharmacopoeia.