The term ‘Pharmaceutical formulations manufacturer’ is often mixed up with the term, ‘bulk drugs manufacturer’. Though they indicate more or less the same thing that is provider of medicines there is a thin line of distinction between the two and it is necessary to get the basics right.
Understanding the Basics
Bulk drug or active pharmaceutical ingredient (API) as it is also known is the chemical molecule contained in the medicine that is bought from the chemist and it is this substance that gives the medicine its therapeutic effect. Besides the API, there are certain other ingredients that are included in the medicines and these are the inactive ingredients or excipients as they are called. These can vary from product to product but the bulk drug or API remains the same for the particular medicine as that is the identity of the medicine.
So, with a change in the bulk drug, the medicine changes and if there is no bulk drug present then that product cannot be termed as a medicine. Hence, then one may ask what is the need for inclusion of these inactive ingredients in the medicine and whether do they have any curative properties? In almost all cases they do not have any curative properties, though there are some exceptions. The excipients have to be included so that the drug can be obtained by the body through acceptable routes of administration.
The drug manufacturers, in this context, have the freedom to select the excipients based on his commercial interest or the chemical feasibility while formulating the bulk drug. The medicines which are purchased from the chemist are therefore ‘pharmaceutical formulations’. Therefore, to make things clear, when we refer to medicines they are bulk drugs formulations and not bulk drugs per se.
Manufacturers of Bulk Drugs Formulations
APIs or bulk drugs are manufactured in plants which could be far from the units where capsules, topical applications or oral suspensions are made. Almost all APIs are produced in the form of powders. The chemical plants established in each country manufacturer bulk drugs and their working is regulated to meet the standards of quality and safety laid down by the drug regulator of that country.
The Indian Pharmaceutical industry which includes the manufacturers of bulk drugs and the formulations has seen a phenomenal growth in recent years. This is attributed to an increasing demand for cost-effective drugs in the domestic as well as export market. The Indian Pharmaceutical industry has become a strong contender in the international markets due to adoption of Good Manufacturing Practices (GMP) and also WHO GMP norms as decided by the World Health Organization for production of several dosage forms. Bulk drugs falling into main therapeutic groups which require complex manufacturing processes are produced in India today.
The pharmaceutical manufacturers face stringent norms for regulation of prices, quality and patents. Most of the pharmaceutical manufacturers have focused research and development teams who are intensely involved in discovering new molecules and inventing new production processes. All in all, a considerable amount of self-sufficiency has been attained in the formulations industry in India today though the import of some new-generation –technology barrier formulations still continues.
Resource Box: The consumer needs to have affordable medicines to tackle the various ailments that may afflict him. It is hence, necessary to have more and more of such manufacturers who aim to make affordable medication produced under high quality standards, available to all. To know more about one such manufacturer please visit the link, http://www.glumex.net/index.php