Bangalore: Health sciences company Sami Labs Ltd expects to be able to use data from early stage drug tests in India while filing for drug approvals in the US, a move that could potentially accelerate regulatory approvals in the biggest market for pharmaceutical products.
Seeking new markets: Sami Labs chairman and managing director Muhammad Majeed
Sami Labs received approval from the drugs controller general of India, or DCGI, for glaucoma drug Ocufors, derived from a herb, Coleus forskohlii, in 2006. Sami is filing a so-called investigational new drug application with the US food and drug administration (FDA), seeking permission for what are called phase IIb trials (on humans), while skipping phase I and phase IIa trials, which test safety and dosing requirements on animals and a small sample of humans, respectively.
Sami Labs chairman and managing director Muhammad Majeed estimates the global market for drugs used to treat glaucoma to be at least $6 billion (Rs23,760 crore). In the US alone, according to the American Journal of Ophthalmology, management of glaucoma costs about $2.5 billion annually. Sami is following the same tack with other drugs as well. Earlier this month, the company filed a new drug application before the Indian regulator for a “natural” psoriasis drug, which it intends to take to the FDA for phase IIb approval. Its third drug, undergoing toxicity study, for asthma, will follow the same path.
“We have adopted this strategy to have a leg-up at the FDA,” said Majeed.
Since India is now under an amended product patent regime since late 2005, data filed with and accepted by the Indian regulator should also, in theory, be accepted by the FDA, says Hitesh Gajaria, pharmaceutical sector leader at consulting firm KPMG International’s Mumbai office.
“If this works in reality, then it should help Indian companies accelerate their clinical development process by avoiding repetitive data collation and filings. Eventually this will lead to cost savings and faster time-to-market.”
Ashwini Kumar, a former DCGI, points out that it wasn't binding on FDA to accelerate the approval process for a new drug just because the Indian regulator had done so.
“It depends on the US FDA’s discretion if they want to accept it (Indian regulator's approval) or if they find the safety data (acceptable). The examiners may ask for more studies," he said.
Separately, Sami Labs is set to float a subsidiary in Brazil. “This is to tap the Brazilian market as well as its natural and human resources,” said Majeed. The idea is to understand the use of ethnic products in that region and look for plants not tested before. Sami Labs plans to engage locals at its Brazilian unit in research.
Privately held Sami group, with a turnover of about Rs400 crore, struck an alliance with consumer goods company Procter and Gamble Co. earlier this year and has signed deals with three other personal care product companies from the US. “They are for selling our standardized herbal extracts and other ingredients used in skin care products such as wrinkle reducing, skin lightening and skin brightening agents,” said Majeed while declining to name the companies.
Bhuma Shrivastava in New Delhi contributed to this story.