Regulatory Status of Banned Drugs in India

Abstract:

All the formulations are meant for prevention or treatment of ailments and diseases, out of which only a few drugs are lifesaving and essential; rest of the drugs are substitutes for each other. When serious problems occur in health care there is always a “knee-jerk” response by many to impose a ban and thus provide an immediate and definitive response to the issue. While such responses may be emotionally satisfying they often represent answers which are “smarter than we are” and may end up causing more harm than good. Banned drugs are still available in developing countries like India due to lack of law enforcement and physician awareness. Some of these drugs namely Nimesulide, Rofecoxib, Phenyl propanamine and other Over The Counter (OTC) preparations are banned by the US FDA due to their side effects such as agranulocytosis, kidney and liver failure etc, but are still being marketed in India. The government needs to enforce laws and provide information to physicians and patients regarding these drugs through drug information centers. The pharmacist should hold public information campaigns and educate consumers, and thus play an important role on eliminating the market for banned drugs.

Key words: Banned drugs, regulatory bodies, unapproved drug.