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May 10, 1999 |
Anatomy of the 'energy' marketSildenafil citrate Better known as Viagra. The hype surrounding its launch in the US was perhaps comparable to the release of Godzilla, the movie. And if the proof of the pudding is in the eating, the advertising campaign worked. The molecule -- Sildenafil citrate -- is the first molecule projected to touch a revenue of US$ 5 billion in the very first year. To put that in perspective: the size of the whole Indian pharma market is $4 billion. Another first: patent periods are fixed at 20 years to help the researcher/scientist to recover his/her costs and make his due share of money. With Viagra, Pfizer is likely to recover its development costs on the drug within the very first year -- unheard of in the drug industry. Prozac But what really changed the drug scenario was Prozac. It was a non-lifestyle drug that began to be used -- misused really -- as the new elixir for the end-of-the mill millennium lifestyle. Prozac was meant for Compulsive Obsessive Disorder. Something like in the movie As Good As It Gets. But not quite as funny. It can become life threatening in its extreme form and Prozac was an important therapeutic milestone in psychiatric/neurological medicine. Today, it is popped before exams, after a fight, before a date, after a hard day -- basically, at the simplest possible excuse. While that's bad for the consumer's health, it's done the company's health a world of good. Prozac is projected to touch the $4-billion mark this year. Ranitidine This was perhaps the first drug to have hit big time, pharmacologically. It is not a lifestyle drug. Strictly speaking, it would be defined as a therapeutic medicine. But the disease it treats -- ulcer -- is largely a lifestyle affliction and the US lapped it up like a starved populace as soon as it was released. Glaxo made $3 billion in sales in the first year, and though the drug is now losing ground in the US where analogues have taken up, it is being picked up in other parts of the world. For instance, in February this year, Cheminor Drugs, a group company or Dr Reddy's Laboratories, received a tentative US FDA approval for manufacture and sale of 75 mg Ranitidine hydrochloride tablets. The Desi Viagras They call themselves "energisers". However, their packaging is clear about what they really are -- almost invariably, there is a picture of a man and a woman looking into each other's eyes. Ayurvedic aphrodisiacs fortified with age-old magic potions -- ginseng, ashwamedha, even gold. Here's a rundown on a small sample. Ozomen
Mighty Forte
Potentex
Spy
Nirvana Honeymoon pack
Renergey
Gentlee S
K K Forte
Nirvana
THE LONG ROAD Step 1 Pre-clinical trials: Like any new discovery, it could take from a few months to a few years, even decades. And science is no more about the pioneers. Experimentation has become expensive and therefore collaborative -- under private or government concerns. The discovery of Sildenafil citrate, for instance, took over half a billion US dollars. Step 2 Filing for an IND application *The new molecule or chemical has then to be registered with the central drug authority and an IND -- Investigating New Drug -- application made. In the US, the drug authority is the FDA or the Federal Drug Authority. In India, it is the DCI or Drug Controller of India. Step 3 To find a new chemical *Tests have to be done to determine the chemical's properties. This helps in deciding if the chemical can be used in the treatment of any disease. Step 4 Clinical trials: During clinical trials, pharmaco dynamic and pharmaco kinetic tests are made on the drug and it is tested for safety and efficacy. Clinical trials, the world over, are done in three phases:
Phase I: Trials on Animals After Phase III, the drug is logically ready for launch. But between this state and the final launch, there is another phase.
Phase IV: Post-market. Surveillance. Kind courtesy: Sunday magazine RELATED REPORTS: Interview with Raghvendra Rao, MD of Orchid Chemicals, makers of 'Indian Viagra' |
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