Dr DBA Narayana, senior scientist, and chairman of Indian Pharmacopoeia Commission (IPC) Herbal Products Committee (HPC) has now categorically stated that the inclusion of phyto-pharmaceuticals in the draft regulations of Drugs & Cosmetics Rules is defensible and warranted.

Incidentally, Dr Narayana was one of the members of the expert committee appointed by the Central Drugs Standard Control Organisation (CDSCO) to address the issue associated with standards of pharma-pharmaceuticals and reference substances.

“There is a serious misunderstanding by the Ayush sector on this. The draft notification D&C Act & Rules creates regulatory provisions of defining phyto-pharmaceuticals or botanical-based drugs and a schedule providing requirement of scientific data on quality, safety and efficacy for the same. The leads for phyto-pharmaceuticals can have their origin not only in traditional medicines like ASU, traditional Chinese Medicine, Kampo Medicine, Bhutanese Medicines or from Ethno-botany, tribal medical practices and such other sources. Most nations are already putting regulations for access and benefit sharing in such cases and exploitation will not be going unregulated,” Dr Narayana, told Pharmabiz.

Draft regulations are under Chapter IV of D&C Act, and Rules, and hence related to the same class of drugs like synthetic drugs based products.

ASU drugs are regulated under Chapter IVA of D&C Act, and Rules, and hence  does not have any impact on this. Those who wish to continue to manufacture and sale ASU drugs under the current ASU licensing system of Grantha preparations or Proprietary ayurvedic medicines or other license allowed under law can do so. It is also not a mandatory provision that applies to ASU drugs in any way, he added.

Additionally pharmaceuticals should not be confused with ayurvedic drugs because it can be from a botanical source from any part of the globe. It is also in line with regulations in US, China, Europe involving scientific evaluation and data generation. It does not simply depend on traditional knowledge alone.

Phyto-pharmaceuticals proposal would promote innovations and development of new drugs from botanicals in a scientific way. It boost India’s research in drug development. In fact, it would permit development as a drug under chapter IV of Drugs and Cosmetics Rules, adopting the Drug Development Technologies involving modern techniques of Solvent Extraction, Fractionation, Potentiating steps, add-back techniques, modern extraction techniques like CO2 based extraction, freeze-drying, formulation developments, and many other techniques. Stress on high degree of characterization of the plant based ingredient as a phyto-pharmaceutical is a requirement that is not generally asked for any traditional medicine (TM.). Ayurvedic drugs are regulated differently and need to meet the requirements given in authoritative texts recognized in the schedule and also have to be processed using methods given in such texts, he said.

Moreover, phyto-pharmaceuticals would need to be mandatorily evaluated for  safety or toxicology and efficacy through human clinical trials on similar lines of synthetic compound based drugs. Such mandatory requirements do not apply to ayurvedic medicines. Information on possible mechanism of action also is a requirement, not generally known in traditional medicine. When approved by Drug Controller General of India (DCGI) these drugs would have the same status for marketing as that given for a synthetic compound based drug. The committee that prepared these draft regulations which is approved by DTAB, has recommended that such products licensed under these regulations may be allowed to be prescribed by both MBBS and BAMS qualified physicians, he said.