APIs are bulk drugs that are pharmaceutically active and generate a desired pharmacological effect, whereas, excipients are pharmacologically inactive substances that are generally used as a carrier of the API in the drug.
Himachal Pradesh Government has identified around 1400 acres in Una district and sent a proposal to the Centre seeking a grant to set up a bulk drug park. A bulk drug also called an active pharmaceutical ingredient (API), is the key ingredient of a drug or medicine, which lends it the desired therapeutic effect or produces the intended pharmacological activity. For example, “paracetamol” is the bulk drug, which acts against pain. Bulk drugs are 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.
Promotion of Bulk Drug Parks Scheme –
The government aims to develop 3 mega Bulk Drug parks in India in partnership with the States. Government of India will give Grants-in-Aid to States with a maximum limit of Rs. 1000 Crore per Bulk Drug Park. 1/9 A sum of Rs. 3,000 crore has been approved for this scheme for the next 5 years. Facilities: Parks will have common facilities such as solvent recovery plant, distillation plant, power & steam units, common effluent treatment plant etc.
The need of the Scheme: Despite being 3rd largest in the world by volume the Indian pharmaceutical industry is significantly dependent on import of basic raw materials, viz., Bulk Drugs that are used to produce medicines. In some specific bulk drugs, the import dependence is 80 to 100%. The scheme is expected to reduce the manufacturing cost of bulk drugs in the country and dependency on other countries for bulk drugs. The scheme will also help in providing a continuous supply of drugs and ensure the delivery of affordable healthcare to the citizens. Implementation: The scheme will be implemented by State Implementing Agencies (SIA) to be set up by the respective State Governments.
What are Bulk Drugs or APIs?
A bulk drug also called an active pharmaceutical ingredient (API), is the key ingredient of a drug or medicine, which lends it the desired therapeutic effect or produces the intended pharmacological activity. For example, paracetamol 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. APIs 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 API, DI and KSM. This year, drug manufacturers in India suffered repeated setbacks due to disruption in imports. Factories in China shut down when the country went into a lockdown, and later, international supply chains were affected as the Covid pandemic gripped the entire world, The border conflict between India and China exacerbated the situation.
Central govvernment scheme for Bulk Drug
The Centre’s 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.
What does a bulk park offer ?
A bulk drug park will have a designated contiguous area of land with common infrastructure facilities for the exclusive manufacture of APIs, DIs or KSM, 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.
Why Himachal for Bulk Drug ?
Himachal already has Asia’s largest pharma manufacturing hub, that is the Baddi-Barotiwala-Nalagarh industrial belt, and the state produces around half of India’s total drug formulations. Himachal offers power and water at the lowest tariffs in the country, and the state also has an industrial gas pipeline. It jumped nine places in this year’s ease-of-doing-business rankings declared by the Centre last month, securing the seventh position in the country.