Indian pharma industry should look at accelerating its research in new drug development focusing on phytopharmaceuticals. The country has already put in place regulations and as of now 500 investigational new drug applications for botanical drugs are under review with the USFDA, said Dr. DB Anantha Narayana, member, Indian Pharmacopoeia Commission.

The pharma scientists in the country involved in innovation work in silos without exposure to aspects of regulatory, environmental and entrepreneurial climate that impact their work. It is high time the pharma industry looks at the potential of phyto-pharmaceuticals. This is where we see the need for working knowledge of regulatory aspects as an essential factor for Indian pharma scientists to successfully develop a drug, he added.

Absence of a dedicated provision in drug regulations to promote innovation in botanical drugs hindered innovation. Many attempts to get such regulations modified did not succeed in India. It was the USFDA which took the lead and announced a guidance to the industry for botanical drugs in 2004 giving the data guidelines.

“Now some of us in India have approached the government to create the necessary regulations and the Indian Pharmacopoeia Commission took the initiative to promulgate phytopharmaceuticals as drugs amending the Drugs and Cosmetics Rules 1954. With this provision in the law, innovation in drug development from botanicals is expected to change face of this sector because it would cost less than a new chemical entity (NCE) and should be quicker to get to the market. This is driven by its safe use and efficacy available for botanical drugs globally,” said Dr. Narayana who was elected for the Dr. Parvinder Singh Memorial Lecture award recently.

Delving on the topic, ‘Innovations in pharmaceutical industry, research in India and opportunities for the future’, he said that if USFDA is looking at as many as 500 applications of this botanical drug category, then Indian pharma industry and its researchers should take advantage and lead the effort. A number of chronic ailments, orphan drug and non-communicable diseases exist where unmet needs of patients offer opportunities for drug development.

New drug development has originated in botanicals. It is a known fact that as much as 60 per cent of the new chemical entities have their origin in a lead compound coming from botanicals. For instance Ephedrine, Reserpine, Vincristine and Paclitaxel are just a few notable lead compounds successfully developed from a naturaly occurring compound. The traditional knowledge in India and botanicals from western nations, traditional Chinese medicines, etc offer a plethora of leads.

“Our country has the unique distinction of vastly documented evidence of such information on drugs in ayurveda, Charak Samitha, Shushrut Samita, Ashtanga Hridaya, Madhava Nidana, Bhava Prakash Nighanttu. These authoritative texts have information on a large number of medicinal plants with therapeutic activity. It was the Central Drug Research Institute (CDRI) which scientifically evaluated many such herbs to assess the product development viability. It took 11 years before Gulgulu tablets were approved as a lipid lowering agent by the DCGI. Today we do not see Guglip tablets in the market due to sustainability issues for Gulgulu resin as raw material and development of statins which showed better activity than Guglip. Other botanicals listed in the innovation category are Arteether, a compound isolated from Artemisia to treat malaria, Memory Plus, a Brahmi plant extract and Colforesin, an extract from Coleus forskholli used as bronchodilator and to reduce intra ocular pressure in glaucoma. Therefore it is high time for India now to undertake researches on phytopharmaceuticals, said Dr. Narayana.