1. It should be established whether the local general
or specialist has considered the drug to be of proven clinical value based on
their experience with it.
2. The drug must be recognized by the pharmacopeias
and formularies approved under the Drug and Cosmetic Act and Rules thereunder
and the National Formulary of India and their supplements and revisions.
3. The manufacturer of the drugs must be licensed
under the Drug and Cosmetic Rules and should not be known to have been punished
for any serious offense under any laws about drugs and medicines. He should be
of proven integrity and dependability. He should have a reputation for
initiating and supporting research activities of merit.
4. No preparation of secret composition will be considered
or admitted to the formulary. As a matter of fact, under the provision of the
Drug and Cosmetics Act Rules, such a provision in the Drugs Act i.e. secret
formula of a drug registered with the Central Drugs Laboratory, Calcutta has
been deleted from the Act long ago.
5. No product of multiple ingredients shall be
admitted if the same therapeutic effect can be achieved through the use of a
single drug preparation.
After the Pharmacy and Therapeutic Committee decides
upon a set of principles for its guidance in their decisions regarding the
additions or deletion from the hospital formulary is felt necessary that these
guidelines may be included in the finished publication. Further, it would be
expedient to circulate amongst the medical staff so that they may have prior
knowledge about them and therefore, enquire about understanding as to why a
particular product may not have been included in the final publication.