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Active Pharmaceutical Ingredients (APIs)

Pharmaceutical drugs may be available in form of tablets or capsules but their actual components are far from homogenous. There are various chemicals included in the drugs and the portion that actually works in treating the condition i.e. the active part is known as ‘Active Pharmaceutical Ingredients’ or API in short. Sometimes a drug may also contain several API and the reaction or response to any particular drug will depend on the dosage prescribed, which varies from person to person. The function of the API is not limited to treatment or cure of the disease or symptoms alone though, they are also used for diagnosis or prevention at times.

While each drug also consists of an excipient part, known as a carrier, it is the API that is considered while prescribing a drug. Quality control is therefore of utmost importance when it comes to the manufacture of drugs. The pharmaceutical companies, both in India and elsewhere in the world have to adhere to strict standards of drug manufacture. The standards followed for using a certain strength of API is not always uniform though. The strengths of the API tend to vary from one brand to another in spite of being the same drug generically.

The pharmaceutical drug industry of India is growing by leaps and bounds at present and is currently valued at $20 billion approximately. After meeting about 70% of the domestic demands, the pharmaceutical industry has also succeeded in making its markas one of the leading bulk drugs exporter of the world as it produces almost 10% of the world’s API due to its strong scientific inclination and availability of technically sound manpower for production of pharmaceutical drugs.

India is now one of the leading exporters of bulk drugs and supplies them to more than 200 countries world wide including the regulated western markets of USA, Europe, Australia, and Japan.An exporter of bulk drugs (API) in India needs to get in touch with the Hyderabad based ‘Pharmaceutical Export Promotion Council’ (Pharmexcil) for registration and obtaining membership certifications as per the ‘Foreign Trade Policy of Government of India.’Pharmexcil works extensively in encouraging export of API via sending delegations outside India, holding business conferences within the country and arranging for funds occasionally.

The Government of India is keen to increase the exports of Bulk drugs (API) even more and has done away with all Industrial licenses in this area along with its formulations and intermediaries. The Indian bulk drug exporters can now hope for clearance without any delay by the ‘Drug Controller General’ (India). However, there may be certain regulations laid down by the policy makers from time to time.

Cadila Pharmaceuticals Limited is a promising name in the Indian pharmacy market. With about 40 APIs and its intermediaries and 850 formulation products for 45 different therapeutic sections like anti allergic, antibiotics, anti-diabetes etc, and about 12 specialties like oncological, immunological and cardiovascular medications, Cadila does not need any special introduction as it has been serving India for past 62 years. In 1997, it ventured into international market by stepping into US pharmaceutical industry as Cadila Inc. and now it has spread its wings in more countries. All its products are approved by regulatory bodies like USFDA in America, ISO certification in India and so on. It is a matter of pride to find an Indian enterprise is going places and giving tough competition to top notch companies of the world.

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