Question

Consider the following statements :-

1. Bulk Drugs are the finished product of Active Pharmaceutical Ingredient and the excipients.

2. An API is a result of a complex chain of chemical reactions with a number of stable Intermediates.

3. India is heavily import-dependent for APIs from China.

Which of the above statements is/are correct
(a) 1, 2 and 3
(b) 1 and 2 only
(c) 2 and 3 only
(d) 3 only​

Answer 1

Option C - 2 and 3 Only

• Statement 1 is incorrect :- Bulk drugs and the API are the same.

■ Explanation :-

• API (Active Pharmaceutical Ingredient) is the basic drug itself with the desired medicinal (pharmaceutical) properties. It is also referred to as Bulk Drugs.

• Intermediates – Most chemical reactions are stepwise, that is they take more than one elementary step to complete. An API is a result of a complex chain of chemical reactions in several steps. Intermediates are stable forms a few steps away from the final API e.g. API -3, or API-5.

• Finished Dosage or Formulation is the form in which the drug is consumed by us. A dosage form of a drug is usually composed of two things: The API, which is the drug itself; and an excipient, which is the substance of the tablet, or the liquid the API is suspended in, with other masking, stabilizing and binding agents/material that is pharmaceutically inert.

• India is heavily import-dependent for APIs from China. India’s API imports stand at around $3.5 billion per year, and around 70%, or $2.5 billion, come from China. The Hubei province of China is the hub of the API manufacturing industry.

• The government aims to develop 3 mega Bulk Drug parks in India in partnership with States to decrease the import.

Hope It helps you

Answer 2

option C is the answer.

hope it helps u