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What is a bulk drug park, and why does Himachal Pradesh want one?
Himachal Pradesh is vying for the allotment of a bulk drug park under a central government scheme.
The Central Government is planning to setup three such parks across the country.
What are bulk drugs or APIs?
A bulk drug is also called an active pharmaceutical ingredient (API).
It is the key ingredient of a drug or medicine, which lends it the desired therapeutic effect or produces the intended pharmacological activity.
- Take for example- Paracetamol– It is a bulk drug, which acts against pain. It is mixed with binding agents or solvents to prepare the finished pharmaceutical product, ie a paracetamol tablet, capsule or syrup, which is consumed by the patient.
How are APIs prepared?
They are prepared from multiple reactions involving chemicals and solvents.
- The primary chemical or the basic raw material which undergoes reactions to form an API is called the key starting material, or KSM.
- Chemical compounds formed during the intermediate stages during these reactions are called drug intermediates or DIs.
Why is India promoting bulk drug parks?
India has one of the largest pharmaceutical industries in the world (third largest by volume).
But this industry largely depends on other countries, particularly China, for importing APIs, DIs and KSMs.
So, any disruptions in those countries would definitely affect the pharmaceutical industries here in India.
- For instance, this year, drug manufacturers in India suffered repeated setbacks due to disruption in imports due to Covid 19.
- The border conflict between India and China exacerbated the situation.
So, what India is doing?
Call for greater self-reliance: In June, the department of pharmaceuticals announced a scheme for the promotion of three bulk drug parks in the country.
- A bulk drug park will have a designated contiguous area of land with common infrastructure facilities for the exclusive manufacture of APIs, DIs or KSMs, and also a common waste management system.
- These parks are expected to bring down manufacturing costs of bulk drugs in the country and increase competitiveness in the domestic bulk drug industry.
Key features of the scheme for promotion of Bulk Drug parks:
- The scheme will support three selected parks in the country by providing a one-time grant-in-aid for the creation of common infrastructure facilities.
- The grant-in-aid will be 70 per cent of the cost of the common facilities but in the case of Himachal Pradesh and other hill states, it will be 90 per cent.
- The Centre will provide a maximum of Rs 1,000 crore per park.
- A state can only propose one site, which is not less than a thousand acres in area, or not less than 700 acres in the case of hill states.
- Key features of the scheme mentioned above.
- What are active pharmaceutical ingredients?
- APIs in fixed- dose vs single- dose drug combinations.
- What are excipients in Medicine?
Sources: Indian Express.