Union government has notified draft rules on phyto-pharmaceuticals that will form the basis for a regulatory system to evaluate and get approvals of plant based drugs.
The draft is a further amendment to the Drugs & Cosmetic Rules 1945 which will be known as the Drugs & Cosmetics 5th (Amendment) Rules 2013. Now in Rule 2 of the D&C Rules 1945, after clause (ea), there will an insertion (eb) on phyto-pharmaceuticals, drugs that would include processed or unprocessed standardized materials derived from plants or parts thereof. It could also be a combination of plant extracts or fractions in a dosage form for internal or external use for human and animal consumptions. But the draft does not include plant-based drugs for parenteral route administration.
In Appendix I-B the norms provides details to be submitted along with application to conduct a clinical trials or import or manufacture of a phyto pharmaceutical drug.
There is a focus on pharmacognostic which is related to the description of medicines derived from plants. The norms call to describe the taxonomical identity, harvest location, growth conditions, stage of plant growth at harvest, collection, washing, drying, preservation procedures, besides transportation and storage methods.
Further, the draft has highlighted the quality specifications including submission of information on foreign matter, moisture content, total ash, acid, insoluble ash, insecticide residue, heavy metal contamination and microbial load.
An undertaking to supply specimen sample of plant duly labelled and photocopy of the identity confirmation certificate issued by qualified taxonomist along with drawings of the diagnostic, morphological and histological features of the botanical raw materials used to validate its authenticity need to be submitted.
Under processing of extracts, details need to be specified on steps used with the references to the changes including enrichment processes.
On the formulation of phyto-pharmaceutical drugs, the regulations of active ingredients need to be indicated. In addition, information on composition, proportion of extracts per unit dose, name and proportion of all excipients, stabilizers and any other agents used along with packaging specifications need to be submitted.
Other mandatory details to be furnished are stability data, safety data, pharmacovigilance, animal toxicity and safety information, proof of concept or confirmatory clinical trials and post marketing surveillance data.
“This is a major step that should promote innovations and pharma industry can now look forward to new route to drug development from herbal plants based on science and technology,” stated Dr DBA Narayana, pharma consultant.
The efforts to prepare draft on phyto-pharmaceutical regulations which is to be included in the D&C Rules has been going on since June 2008 when Dr Surinder Singh former DCGI was convinced by panel of experts on the need for regulatory framework for scientifically developed herbals to be evaluated and approved as drugs. It was only in August 2013 that the final text for gazette notification for phyto-pharmaceuticals was approved by the by Ministry of Law to be included under the regulatory provisions of D&C Rules. The same is awaited for notification in the Gazette, said Dr Narayana.
According to Prof. SS Handa, former director RRL, Jammu and leading plant scientist, first drug policy of India has been implemented after over six decades. We have yet to go long way to contribute scientifically to raise the status of this segment.