Indian drug companies may have to withdraw hundreds of brands of 36 life saving drugs currently marketed in the country if the third amendment to the Patent Act is passed without some critical changes, it is learnt. The approximate market value of the formulations of these drugs is estimated at Rs.3000 crore.

These brands belonging to various companies are either reverse engineered or innovated in the country but are life saving preparations. While the existing process patent regime allowed the manufacturing and marketing of these drugs, the shift to product patent era from January 1 2005 may invite patent infringement charges from the patent holders.

The brands and generics of these 36 drugs that will have to be withdrawn from 2005 are Amlodipine (anti-hypertensive), atorvastatin (anti-cholesterol), azithromvcin (anti-biotic), cefprozil (anti-biotic), cerivastatin (anti-cholesterol), cetirizine (antihistaminic), elatriptan (anti-migraine), erythropoietin (anti-anaemic), esomeprazole (anti-ulcer), finasteride (prostrate disorder), gabapentin (anti-epilepsy), gatifloxacin (antibiotic), hepatitis vaccine (vaccine), insulins (anti-diabetic), itraconazole (anti-fungus), lamivudine (anti-HIV), lansoprazole (anti-ulcers), levofloxacin (antibiotic), linezolid (antibiotic), losartan (anti-hypertensive), mometasone (topical steroid), montelukast (anti-asthma), nevirapine (anti-HIV), olanzapine (anti-depressant), pantoprazole (anti-ulcers), pioglitazone (anti-diabetic), paroxetine (anti-depressant), rabeprazxole (anti-ulcers), rosiglitazone (anti-diabetic), sertraline (anti-depressant), simvastatin (anti-cholesterol), stavidine (anti-HIV), terbinafine (anti-fungal), zidovudine (anti-HIV), zolpidem (sleep disorder) and levocetirizine (anti-histaminic).

Sensing the danger, hectic lobbying is already on to see that the third amendment of Patent Act is including some protective measures that can ensure continued presence of all existing legally approved drugs, whether or not they are under the patent protection elsewhere, it is learnt.

When contacted, S V Veerramani, vice-president (South Zone), Indian Drug Manufacturers Association (IDMA) informed that the matter is being taken up at the highest level and the industry is expecting a favourable response from the government. “ There are provisions in TRIPS. As per Article 70 (8) of TRIPS, certain drugs can be excluded to ensure the uninterrupted supply of certain life saving medicines. It is the duty of our Government to ensure these drugs continue to reach its current users. We have invested hugely in terms of infrastructure, plants and machinery to make these drugs. We are legally entitled to produce these drugs as per the existing rules now. The changes in laws should be applicable only to the new drugs but not to the existing drugs. We should be protected from any possible legal challenges that may arise in future,” said Veerramani.