Chronicle Pharmabiz
Nandita Vijay, Bangalore
Saturday, April 08, 2006

Dept Ayush selects Sami Lab for developing SOPs in herbal extracts

SAMI Labs has been selected by Department of Ayush for the development of standards operating procedures (SOPs) and pharmacopoeia standards for extracts of ayurvedic siddha and unani drugs.

The project which is a centrally sponsored scheme for the development of monographs of 15 ayurvedic medicinal plant extracts, Sami Labs will have to develop SOPs for extraction of plants collected from different geographical locations and extracted by different manufacturers, which will help conform to a single specification. It would also decide the most suitable solvent for extraction of these plants. Further the company will have to generate stability date, using accelerated stability to ensure the phytochemical stability of each extract for a minimum period of two years from the date of manufacture.

Although several pharmacopoeia standards are under the guidance of the Ayurvedic Pharmacopoeia Committee (APC) and four volumes of Ayurvedic Pharmacopoeia of India have been published by the department of Ayush on 326 single drugs, yet there are no monographs available for extracts.

The benefits associated with medicinal plant extracts over crude herbs are reduction in the bulk drug utilization, convenience of developing modern dosage forms, better control over the chemical quality and reduction in microbial burden.

The quality of the herbal extract depends on parameters like quality of the raw material, type of process adopted and amount of excipients added to the extract, stated Dr. Muhammed Majeed, chairman and MD, Sami Labs. In this project SOPs of 15 popularly used medicinal plants are being developed with analytical specifications/Pharmacopoeial monographs for their quality assessment, including data on their phytochemical stability for a minimum period of two years, he added.

Sami Labs will have to collect 30 kg of each raw material. Wherever possible, preference would be given to cultivated raw material, some basic information about the raw material origin, method of drying, post harvest treatment would also be documented simultaneously, The raw material will be analyzed according to Ayurvedic Pharmacopoeia of India norms. A 250 g sample of each crude drug (unpowdered), from the company along with its certificate of analysis would be deposited at PLIM as voucher specimen/ control sample, To decide the most suitable solvent, each raw material will be extracted with water and 50% aqueous alcohol.

For the preparation of extracts Sami Labs will propose two general “procedures for extraction” to be followed, one for water extracts and the other for hydroalcoholic extracts. The company has been assigned to extract minimum 15 kg of each raw material and document complete details about the extraction process in a batch manufacturing record. It is estimated that 15 kg of raw material would yield minimum 1 kg of extract. After the extraction, a 100 g sample of each extract along with basic details would be again deposited at PLM, Ghaziabad, as a voucher specimen

Sami Labs was short – listed for the project because it has been an exporter of standardised herbal extracts, The Company has sophisticated in house laboratory, recognized by the Department of Scientific and Industrial Research (DSIR), It also has a division specializing in phyto-chemical reference standards which develops analytical methodology for more then 100 phyto –pharmaceutical products. All these factors contributed for being short –listed for the project, stated Dr.Majeed.