The final list has also been approved by the law ministry.
MNC pharma companies to be affected by the new DPCO include Hoechst Marion, Novartis, Knoll Pharma, Glaxo, German Remedies, USV, Fullford India and Wyeth Lederele.
Hoechst Marion will be one of the most affected as four of its medicines (which have the largest market shares in each molecule) will now come under the price control. Out of these, two are new additions. Hoechsts turnover to the tune of Rs 150 crore (as on March 2001) will now be under price control .
Similarly, three medicines each of Novartis India and Knoll India will now fall under the price control. Novartis drugs under price control are Diclofenac, Calcium Carbonate and Xylometazoline having a total turnover of over Rs 111 crore. Knolls three drugs -Ibuprofen, Insulin and Phenytoin (largest selling drugs in that category) have a total turnover of Rs 184 crore.
The final list of 30 molecules includes 15 new additions while the balance 15 will be carried forward from DPCO 1995. The 15 new molecules are: Diclofenac, Metformin, Norfloxacin, Calcium Carbonate, Bisacodyl, Cefotaxime, Cefuroxime, Chlo-rpheneiramine, Glibenclamide, Povidone Iodine, Norethistero-ne, phenobarbitone, Phenytoin, Promethazine, Rabies Antigen and Xylometazoline.
The carried forward molecules are: Insulin, Amikacin, Betamethasone, Chloroquine, Erythromycin, Streptomycin, Ibuprofen, Norfloxacin, Pent-azocine, Pheniramine, Prednis-olone, Rifampicin, Salbutamol Framycefin and Glipizide.
The implementation of the new DPCO could take some time since the Karnataka High Court has granted a stay on the new drug policy. However, the Union government is planning to move the Supreme Court against the High Courts stay order to speed up the implementation of the policy.
Among the Indian companies affected by the new DPCO include Alembic Limited, Aristo Pharma, Alkem Laboratories, IPCA Laboratories, Win Medicare, Franco India, Ranbaxy, Lupin and Sarabhai. Each of these companies has one medicine (the market leader in that molecule category) under the price control. However, two of Ciplas top selling medicines in that category - Salbutamol and Norfloxacin - will be under price control.
As per the new criteria used for inclusion, a single medicine having an annual turnover of more than Rs 25 crore (as on March 31, 2001) and its formulation having a market share of 50 per cent were put under price control. Further, a medicine with a market share of less than 50 per cent in that molecule category has been excluded even if its annual turnover was more than Rs 25 crore.
Another criteria used for inclusion was a medicine with annual turnover between Rs 10 crore and Rs 25 crore with a market share of over 90 per cent.