Local generics hit it big in '04
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KOLKATA: It was gung-ho for Indian pharma companies in '04, the last year for launching generic products of new generation molecules invented after 1995.
Indian pharma companies introduced 42 new formulations of which 23 were new molecules, a rise of 11% over '03, a clear indication that companies took full advantage of the last days of generic product regime.
Data available from the Central Drugs Standard Control Organisation points out key generic of blockbuster molecules launched in India during '04 include dutasteride, imidapril, adefovir, etoricoxib, diacerein, nitazoxanide, alfuzosin, tiagabine, memantine, miglitol, citicholine, orlistat, duloxetine and atomozetine.
Interestingly, domestic pharma companies received the nod of Indian regulatory authorities for most of these molecules in about a year's time of the innovator product launches in US.
Check out a few examples. Data available to ET from US FDA and CDSCO show that while US-based Forest Lab received the US approval for the Alzheimer's drug, memantine, in October '03, Sun Pharma received the Indian approval for the generic in July '04.
Similarly, Sanofi-Synthelabo received US FDA approval for alfuzosin in June 2003, Ranbaxy received the approval for the generic in May '04.
While Eli Lilly received US FDA approval for their anit-hypertensive drug duloxetine in August '04, Torrent Pharma launched the generic in November '04.
However, the pattern of new product launches in India is now set for a major transformation, thanks to the product patent regime from January 1 '05.
The companies will still be able to launch products that were invented before 1995, but analysts feel that these will hardly find any favourable market.
"Hence, the main focus of the Indian companies will be on launching products developed on novel drug delivery system (NDDS) or through tie-ups with MNCs that enjoys the patent," Somesh Sharma, chief scientific officer, Nicholas Piramal India, told ET.
Industry analysts feel that the number of new generation product launches will also take a hit in '05, since it will take sometime for the government to process the 12,000 patent applications in the 'mail box'.
Current estimates suggest that it will take up to 30 months to process the patent applications. Moreover, the Indian companies will have to withdraw the generic drugs from the domestic market once the innovator gets the patent.
Source: economictimes.indiatimes.com