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India needs to devise practical tests to develop ‘botsimilar’ on similar lines of biosimilars: Dr DBA Narayana
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Nandita Vijayasimha, Bengaluru
April 15 , 2024
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India needs to move towards developing practical and implementable tests that can give larger number of data points for the development of botanical biosimilars (Botsimilar) on similar lines that of biosimilars. The pharma industry in the country is making a strategic shift towards botanicals or phytopharmaceutical formulations of medicinal plants and herbs. This is because of the dwindling new chemical entity (NCE) pipeline which is driving an increased interest to go back to nature, said Dr DBA Narayana, CSO, Ayurvidye Trust.
Botsimilars should be statistically satisfactory to compare similarities between a reference batch of a botanical material processed as per traditional documented processes with a history of safe usage, he added.
Pharmacognosists and phytochemists should consider working with analytical experts involving a statistician and should generate data on few samples to come out with one or more approaches for similarity testing.
If in biological materials, protein based, rDNA-based drugs, insulins, vaccines have been developed as biosimilars which has regulatory approvals, then there is a need to look at botsimilar. The Union government policy of One Nation, One Herb, One Standard is a step in the right direction. The task of laying down pharmacopoeial monograph for botanicals was given to Pharmacopoeia Commission of India revolving around mandatory testing for marker compounds, said Dr Narayana told Pharmabiz.
There is no data on the effectiveness of quality testing of raw botanicals by the traditional Ayurveda or pharmaceutical industry or even the nutraceutical supplements manufacturing sector. One often hears of large number of manufacturers in this sector are in micro, small, medium enterprises (MSME) sector. Most often it is heard that this sector has difficulties in the so-called complex marker compound-based analysis and availability of materials meeting such standards, he said.
In a narration on the topic ‘Time to Think Botsimilar’ Dr Narayana said that ever since the Dietary Supplement Health and Education Act (DSHEA) was notified in the US in 1994, discussion on botanicals for wellness continues. Botanicals to be used for providing wellness health benefits opened up a large market for consumer benefits. India and China have long documented history of safe usage of botanicals and began to explore the US market for supplements.
Botanical products, mostly single herb based and their extracts formulated as tablets, capsules, liquids and in some cases food formats such as granules, powders, became the focus of innovations. For over two decades hundreds standardization of botanicals has been deliberated, said Dr Narayana, adding that the US and Europe demanded standardized botanicals of quality.
In the absence of an alternative scientific approach, the pharmaceutical method of testing of botanicals for the bio active compound or marker compound was pushed forward. Soon problems of identifying the bioactive compounds, isolating, purifying and characterizing them affected this approach, said Dr Narayana.
There exists inadequate scientific logic on marker compound approach. Botanicals on consumption gets exposed to gastric fluid and intestinal fluids leading to changes in chemistry. In traditional knowledge botanicals are extracted in a different medium linked to different therapeutic benefits. Such processes are also aimed to reduce adverse events. Therefore India needs to develop botsimilars on similar lines that of biosimilars, said Dr Narayana.
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TOPICS
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