Regulatory strategy

A company was marketing an Indian gooseberry based drink concentrate for many years. It was licensed as a drug for all these years. The company now wished to market a single helping formulation of the same, but as a fizz drink, all the while retaining the medical image. Our team reviewed all the drug rules, prepared a white paper and made a presentation to the authorities so as to achieve this goal.

A company marketed a unique barley-based medicine for management of arthritis. It held a patent for the manufacturing process too. An alternate and much valuable effect that was noticed was amelioration of various types pf cancers. The owner of this small-scale manufacturing firm was very curious and studious. He provided free medicine to cancer patients in return for copies of their case records across the treatment period. Over the years he collected several such records in various types of cancers. In most cases improvement was seen in end stage disease. There was no way of knowing whether this was a curative or a chance finding. He had also conducted animal toxicity studies and mode of action studies through interested research groups. An apoptotic effect was noticed. Pharmawisdom was approached to show the way forward. We reviewed all the available data, picked up the most promising leads( types of malignancies) and advised him to approach the authorities with a protocol for one type of cancer at a time. A sample protocol was also provided and funding required was also indicated. Since cancer studies require massive funding, we understand the company is scouting for some partners. We wish them the very best.