08/06/14 4:27 am Formulations and bulk drugs: get the basics right - Economic Times

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Formulations and bulk drugs: get the
basics right
TNN Dec 30, 2002, 12.15am IST
A bulk drug also called active pharmaceutical ingredient (API) is the chemical molecule in a
pharmaceutical product (medicines we buy from the chemist) that lends the product the claimed therapeutic
effect.
In other words, it is the substance responsible for the product being a medicine, penicillin to give one
example. As is evident from this, there are ingredients other than the API in products sold as medicines.
These inactive ingredients-excipients may or may not change from product to product, while the bulk drug
would inevitably remain the same as it is the identity of the medicine.
When the bulk drug is absent, the product is no longer a medicine and when it is changed, it is a new
medicine. One may ask if the existence of the inactive ingredients signify anything to the patient. In the case
of most of the existing bulk drugs, change of inactive ingredients don't impact the curative quality of the
product, although there are exceptions.
This means the drug manufacturers more or less have the liberty to "formulate" the bulk drug using excipents
of his choice depending on chemical feasibility and commercial interests. The medicines in the markets in the
"form" of tablets, capsules, syrups, drops, intravenous fluids etc., are therefore "formulations." In plain
language, the products we refer to as medicines are formulations (of bulk drugs) and not bulk drugs per se.
What are the regulatory procedures for introduction of a new bulk drug/formulation in the market?
Launching a new bulk drug is a hugely expensive proposition requiring rigorous scientific research, enormous
risks of costly failures and validation trials. Some MNCs say they spend $800m for a new drug invention. An
investigational new drug application is being filed before a regulator when a company wants to introduce a
new chemical entity bulk drug with a presumed therapeutic effect.
On the other hand, the formulator merely requires to prove that his product is bio-equivalent to the existing
formulations in the class- that is, the rate and extent of drug absorption don't vary beyond permitted limits
from the extant formulation/s of the bulk drug. In the case of established drugs, the formulators are practically
exempted from this requirement, while in the case of drugs that so far remained under a patent which
means that only the inventor's formulation/s of the bulk drug existed thus far bio-equivalence studies are
mandatory for marketing permit for at least the first few new formulators. This is what happens when Indian
firms closely follow patent expirations to launch their formulations of the patent-expired drug.
Can a formulation have more than one bulk drug?
Although most formulations contain only one bulk drug, there are a large number of formulations containing
more than one bulk drug. The number of such fixed dose combination (FDC) formulations are increasing.
Regulators see a new FDC made by combining two bulk drugs as a "new drug" because unlike inactive
ingredients, these active ingredients require to be verified for their safety and efficacy given the chance of
clinically adverse interactions.
What is a generic drug?
A generic drug is a drug named after the internationally accepted scientific name of the API. For example if a
company sells antibiotic bulk drug Ciprofloxacin by that name, it is generic Ciprofloxacin and if a formulation
of the drug is sold as Ciprofloxacin in the retail market, it is generic formulation of Ciprofloxacin.
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08/06/14 4:27 am Formulations and bulk drugs: get the basics right - Economic Times
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If a company sells the same formulation under its proprietary brand name, then it is a branded drug. Branded
names are capitalised while generic names are not. Generally, prices of generic products are expected to be
lower than the prices of branded items. Although it may be an exemplary ethical practice for a registered
medical practitioner to prescribe the generic name of the drug, it is increasingly becoming a norm to prescribe
brands also. But, the term generic drug is also relative and contextual. This is because it is increasingly being
used to refer drugs that are off-patent. Branded off-patent drugs too are described as generic drugs in the
highly regulated and patent-prevailing markets like the US, whereas in countries like India where there is no
product patent on pharmaceuticals, a non-branded medicine is a generic medicine. To distinguish between the
two meanings of generics, non-branded drugs are also referred to as "generic generics."
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08/06/14 4:27 am Formulations and bulk drugs: get the basics right - Economic Times
Page 3 of 3 http://articles.economictimes.indiatimes.com/2002-12-30/news/27336226_1_bulk-drug-formulations-drug-manufacturers