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May 10, 1999

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Anatomy of the 'energy' market

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Love molecules, pharma wars

Sildenafil 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

  • Rs 49.95 for four capsules.
  • Two capsules with warm milk, two hours before going to bed.
  • Made by Fizikem Labs, Vijayawada.

Mighty Forte

  • Herbal capsules for "extra power".
  • Rs 105 for ten capsules.
  • Two tablets at night with milk.
  • For lasting effect, has to be used for at least four weeks regularly.
  • Made by Priya Pharmaceuticals, Hyderabad.

Potentex

  • Energy rechargers for women (one of the few, if not only).
  • Rs 350 for ten capsules.
  • Two capsules at night with milk.
  • Has Ashwagandha 100 mg.
  • From Arya Vaidya Pharmacy, Palakkad.

Spy

  • "The power to love better".
  • Rs 147 for ten tablets.
  • Two tablets, half an hour after dinner.

Nirvana Honeymoon pack

  • Priced at Rs 151.
  • Has among other things, KamaSutra condoms and Nirvana energisers.

Renergey

  • Rs 50 for ten capsules.
  • 1-2 capsules daily or as directed.
  • Main ingredients: Ginseng extract 65 mg. Ashwagandha extract: 50 mg. Tulsi extract: 50 mg.
  • Made by Helios Gulabi Tekra, Panchwati.

Gentlee S

  • Rs 135 for ten capsules.
  • 1-2 capsules with milk at night.
  • Ashwagandha extract: 50 mg.
  • Made by Ajmera Pharma, Indore.

K K Forte

  • Fortified with gold and Navratna Bhasmas.
  • Rs 150 for 20 capsules.
  • 1-2 capsules a day with milk at night.
  • From Kalpa Pharma, Hyderabad.

Nirvana

  • Energisers from KamaSutra. Now with extra Ashwagandha.
  • Rs 100 for ten tablets.
  • Made by Om Pharmaceuticals, Madras.
  • Marketed by JK Chemicals, makers of KamaSutra.
  • Main ingredients: amber and ashwagandha.

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
Phase II: Trials on Humans
Phase III: Final Testing

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

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