Mumbai: The Drug Technical Advisory Board, or DTAB, a government body that approves changes in drug administration rules before they become part of the law, is expected to consider in July an expert committee’s report on recognizing a new class of drugs known as phytopharmaceuticals.
Phytopharmaceuticals are drugs developed from herbs and plants using modern methods such as toxicity and safety studies on animals and humans, and clinical trials on healthy volunteers and patients.
New opportunities: Freshly harvested herbs and plant material waiting to be processed into Ayurvedic medicines. If approved, the law will help open up an avenue for new drug development.
There are no specific provisions in the Drugs and Cosmetics Act of India for conducting studies for this class of drugs, so they are not recognized as modern medicine.
As a result, many pharmaceutical companies and research organizations, which have successful leads based on plants and herbal science, either do not take them forward to the clinical stage or launch such potential drugs in the market in the form of food or health supplements.
Pharma and consumer products makers such as Himalaya Drugs Ltd, Suven Life Sciences Ltd, Dabur India Ltd, BioSceinces Ltd and many research institutions, including Indian Institute of Integrative Medicines in Jammu, are some of the key players in phytopharmaceutical research.
Since no law is currently available to validate applications and claims from these companies and research organizations for authorizing clinical trials or marketing of such drugs, the Drug Controller General of India (DCGI) cannot process such requests.
But, armed with traditional knowledge of plant medicines, India has the potential to develop several such drugs to treat ailments, including arthritis, hepatitis and migraine.
“If approved, the law will help open up an avenue for new drug development, which may not require the huge capital investment as well as long lead time that is required for chemistry-based drugs,” said D.B. Ananthanaryana, a senior member in the expert committee appointed by the health ministry to recommend standards?for phytopharmaceuticals.
The committee, which submitted its report in October 2008 to the drug controller, had recommended an insertion of the definition for phytopharmaceuticals in the Drugs and Cosmetics Act as a new category under rules that define a new drug.
The rules at present recognize only substances of chemical, biological or biotechnology origin.
The committee has also recommended the inclusion of a new schedule in the act to approve clinical trials of drugs under the new category.
Ashok Vaidya, an Ayurvedic scientist and coordinator of government of India-initiated New Millennium Indian Technology Leadership Initiative that promotes research in niche areas such as new drugs from traditionally known medicinal plants, said he had written to DCGI to make the phytopharmaceuticals report a priority.
“There are no objections so far from anywhere to this recommendation, and hopefully we will get through the approval process soon,” he said.