The Hindu Business Line : Eli Lilly's ED drug likely to face clones' onslaught

PFIZER may have refrained from bringing its anti-impotence drug Viagra into India because of the numerous clones that were rolled out in the market place. And the situation looks just as tricky for another drug in the erectile dysfunction (ED) segment - this time from the Eli Lilly stable.

Cialis is Eli Lilly's drug in the ED segment, set for launch in India this year. The company had applied for an Exclusive Marketing Right (EMR) in India and currently awaits a decision from the Indian Patent Office.

Meanwhile, chemically-equivalent versions of Cialis are being launched in the Indian market - the first of the lot being from Ajanta Pharma.

Cialis is the brandname for tadalafil and Eli Lilly is the original patent holder. Ajanta Pharma's chemically-equivalent version, launched last week, is called Tadalisa.

Pharma industry sources told Business Line that more companies such as Glenmark, Cadila Healthcare, Matrix and Natco are also said to have applied to the Drug Controller's office for marketing the active pharmaceutical ingredient of the same drug.

In fact, point out representatives with the Organisation of Pharmaceutical Producers of India (OPPI): "Such a situation emerges since there is no co-ordination between the Patent Office (with the Ministry of Commerce and Industries) and the Drug Controller's office (under the Health Ministry)."

The official elaborates that, "Getting a marketing approval is one of four pre-conditions to apply for an EMR. The paradox is that once a company gets a marketing approval, it opens the floodgate for generic companies, as they do bio-equivalence studies and get marketing approvals from the Drug Controller's office."

And since an EMR application takes more than two years to be disposed of by the Patent office, the Drug Controller's office cannot block local companies from getting marketing approvals for the same drug in this time. "The Drug Controller cannot stop granting approvals on the assumption that an EMR will be granted. The EMR application could be rejected too," they point out.

The OPPI representative suggests that, "The Patent Office should commit itself to a definite time and EMR applications be disposed of, one way or the other, much faster. The Drug Controller could commit to hold-off other generic applicants if the Patent office disposes with applications, say in four months."

But the Patent's Office is of the opinion that EMRs cannot be given in a hurry, since "it needs to conduct proper due diligence to ensure that a legally correct decision is taken."

Meanwhile, a representative with a domestic drug company said: "EMRs can be given only to drugs registered after 1995. And even with these drugs, generic companies could market their chemical equivalent versions till January 1, 2005 - when the country starts honouring product patents. As for pre-1995 drugs, anyone can market them."

And with both sides of the EMR debate delving into detail for support - drugs seeking an EMR, like Eli Lilly's Cialis, look set to have a rough ride ahead.

More Stories on : Pharmaceuticals | Channels and Franchises | Health

Article E-Mail :: Comment :: Syndication :: Printer Friendly Page