With view to further regulate the phytopharmaceutical sector in the country, the Centre is planning to amend the Drugs and Cosmetics Rules to have a separate definition of phytopharmaceutical drugs and also for its inclusion in the definition of new drug.

The move, already approved by the DTAB, is to introduce phytopharmacueticals under the Drugs and Cosmetic Rules and provide guidelines for permission for their manufacturing and clinical trials in the country, taking into consideration the growing acceptance for these kinds of drugs.

The amendment to the Rules is planned with the purpose of having similar provisions for evaluating their safety and efficacy to authenticate the claims made for the phytopharmaceutical drugs. A separate Appendix I-B was being proposed to be incorporated under the Schedule Y for providing information specific to the phytopharmaceutical products in regard to their origin, pharmacognostic descriptions, quality specifications, process of extraction, stability data, safety and pharmacological information etc. along with the application to conduct clinical trial/import/manufacture of a phytopharmaceutical drug in the country, sources revealed.

Phytopharmaceutical products are drugs of plant origin having therapeutic effect. These are not single substances but comprise of standardized extracts or fractions of processed or unprocessed medicinal plants. These drugs are, however, required to be evaluated for their safety and efficacy like other new drugs belonging to the modern system of medicines.

“The system adopted for evaluation of modern drugs like toxicity, safety and efficacy studies should be made applicable to this class of drugs also. This will help in creating scientific and authenticated data about their therapeutic efficacy and safety,’’ sources said.

The matter was considered in the 60th meeting of DTAB held in October, 2011 and it was agreed in principle to incorporate provisions relating to phytopharmaceutical drugs under the Drugs and Cosmetics Rules. It came up further for discussion in the recent meeting of the DTAB also in July this year and got approval.

“The DTAB welcomed the proposal as this will help in evaluation of many of such drugs of Indian origin on the methods employed for modern medicines. The DTAB, however, recommended that repeat dose toxicity should be on two species of animals and one of them should be non-rodent as is under Schedule Y,’’ sources added.