Sun Pharma Limited and Cipla Limited have topped the list of new drugs approvals by the Office of the Drugs Controller General of India (DCGI) during the year. Both pharma majors have managed to get marketing licenses for six new drugs each during the period between January 1 and October 31, 2002, it is learnt. On the whole, DCGI has cleared 44 new drug applications benefiting 28 pharmaceutical companies during the period.
While six of the companies have two new drug clearances each to their credit, rest 20 have got one new drug each cleared during the year.
The new drugs for which Sun Pharma got approvals are loteprednol, larcanidipine, quetiapine, cabergoline, metexalon and acamprosate. Applications for the marketing licenses of all these drugs except larcanidipine were filed during last year. Cipla however got approvals for long pending applications filed as early as 1998. The new drugs are bicalutamide (applied in 2001), apraclonidene (1998), famcyclovir (2000), tamsulosin (1998), isotretinoin (2000) and valacyclovir (1998).
Aurobindo Pharma (cefepime, ceftiofur), Cadila Healthcare (fosphenytoin, mifepristone), Macleods Pharma Ltd (quinapril, tranexamic acid), Wyeth Laderie Ltd (gemtuzumab, serolimus), Wockhardt Ltd (nadifloxacin, mecobalamin Inj) and Torrent Pharma (ziprasidone, zaleplon) are the companies which have two new drugs cleared during the current year.
The other companies are AstraZeneca Ltd. (meropenan Inj), Allergan India Ltd (dimatoprost - Opth), Cadila Pharma Ltd (Fosinopril Sod.), Ranbaxy (montelukast sodium), Aventis Pharma ((DtaP Vaccine), Nicholas Piramal Ltd ( Thymogen), A Sarabhai Ltd (dexrazoxen), Dr Reddy's Laboratories (mizolastine), German Remedies Limited (miltefosine), Hetero Drugs Ltd (abcavir), Alembic Ltd (nateglinide), Knoll Pharma Ltd (itopride), Pharmacia India Ltd (alprostradil), Serum Institute ( Pygenum A. Extract), Eli Lilly Ltd (drotrecogin alpha), Glenmark India Ltd (valdecoxib), Sarvotam Care Limited (Nebivolol), Dabur India Limited (thalidomide), Emcure Pharma Ltd (S-Amlodipine) and Aristo Pharma Limited (butorphenol).