The drug control administration has recommended that state drug controllers cancel the manufacturing and sale licences for 1,105 drug brands.
These brands belong to about 320 drugs of leading Indian pharmaceutical companies. The Drug Controller General of India's (DCGI's) office feels that these have been launched without its approval.
The list, circulated to the states by the Central Drug Standard Control Organisation (CDSCO), includes drug brands of Cipla and Alkem Laboratories (37 each), Nicholas Piramal (36), Emcure Pharma (30), Ind-Swift (40), Zydus Cadila (30), Mankind Pharma (45), Lupin (21), Intas Pharma (30), Sun Pharma (12), Wockhardt (12), Ranbaxy Laboratories (15), Blue Cross Laboratories (15), Elder Pharmaceuticals (15) and Cadila Pharmaceuticals (28).
Sources close to the developments said that if state drug controllers take action as directed by a recent drug consultative committee (DCC) meeting and the DCGI, drugs worth Rs 3,000-Rs 4,000 crore (Rs 30-40 billion) would disappear from the market, causing a big blow to these companies.
The identified drugs are "irrational" or fixed dose combinations (FDC) -- combining one drug with one or more of approved drugs -- and have been marketed with licences obtained from state drug controllers in the last few years.
M Venkateswarulu, DCGI (in-charge) was not available for comment.
Industry experts said companies use fixed dose combinations for two reasons, the most important being to override the drug price control order, through which the National Pharmaceutical Pricing Authority (NPPA), the government's drug regulator, fixes a price ceiling for 74 drugs.
