The essential component of a drug or treatment that gives it the desired therapeutic effect or causes it to exhibit the specified pharmacological activity is known as a bulk drug, also known as an active pharmaceutical ingredient (API). When combined with binders to create finished pharmaceutical goods like Paracetamol tablets and capsules, it works as an analgesic.
The area known as Bulk Drug Park has shared infrastructure resources for the sole purpose of manufacturing APIs, DIs, or KSM. There will be a shared waste management system at Bulk Drug Park.
The Government of India approved the “Promotion of Bulk Drug Parks” Scheme on March 20, 2020, with the goal of significantly reducing the cost of manufacturing bulk drugs and thereby increasing the competitiveness of the domestic bulk drug industry by facilitating easy access to standard testing & infrastructure facilities.
13 states submitted plans for the building of bulk drug parks as part of this plan. Gujarat, Himachal Pradesh, and Andhra Pradesh have been chosen among them. According to a central government plan to establish three such parks around the nation that was revealed earlier this year, Himachal Pradesh is one of the states competing for the allocation of a bulk drug park.
Himachal provides water and electricity at the nation’s lowest rates, and the state also has an industrial gas pipeline. It climbed nine spots in this year’s rankings for business-friendliness, which were released by the Center last month, to claim seventh place nationwide.
Objectives of the Bulk Drug Park Scheme
- To promote the creation of bulk drug parks around the country so that the bulk drug units located within the park can conveniently use first-rate Common Infrastructure Facilities (CIF). By making the local bulk drug business more competitive, the production cost of bulk medications will be drastically reduced, enabling India to become self-sufficient in bulk drugs.
- To assist the industry in lowering the cost of meeting environmental criteria through creative approaches to the current waste management system.
- To reap the rewards brought about by resource optimization and economies of scale.
- Despite being the third-largest pharmaceutical sector in the world (by volume), India heavily depends on the importation of bulk medications or APIs. According to information provided by the Ministry of Chemicals and Fertilizers, 63% of all pharmaceutical imports into the nation in 2018–19 were bulk medicine imports.
- Indian pharmaceutical businesses encountered difficulties as a result of the new coronavirus outbreak and subsequent lockdowns because API imports were affected.
- The Bulk Drug Park Promotion Scheme has a total budget of Rs. 3000 crores and a five-year duration (2020-21 to 2024-25). With a cap of Rs. 1000 crore per park or 70% of the project cost of Common Infrastructure Facilities, whichever is smaller, the initiative will offer grant-in-aid to three Bulk Drug Parks. The grant-in-aid for hilly states and the North East region is set at Rs. 1000 crore per park or, if less, 90% of the project cost for common infrastructure facilities.
Features of the Bulk Park Scheme
- Through a one-time grant-in-aid for the construction of shared infrastructure facilities, the program will help three national parks that have been specifically chosen.
- In the case of Himachal Pradesh and other hill states, the grant-in-aid will be 90% of the cost of the common facilities instead of the usual 70%.
- The Center would provide up to Rs 1 billion for each park.
- A state may only suggest one location, which must be at least 1,000 acres in size or, in the case of hill states, at least 700 acres.
Benefits of the Bulk Park Scheme
- The bulk drug parks that will be created under this plan will offer shared infrastructure facilities in one location, resulting in the development of a robust ecosystem for bulk drug production in the nation and a significant decrease in manufacturing costs.
- By encouraging domestic production of large quantities of medications and facilitating easy access to infrastructure and standard testing to lessen reliance on imports, the scheme is anticipated to establish a foothold in the international market.
- The plan will assist the industry in meeting environmental criteria at a low cost through creative approaches to the common waste management system, and it will enable it to profit from resource optimization and economies of scale.
Challenges of the Bulk Park Scheme
- Being the second most populated nation in the world, India is one of the biggest marketplaces for pharmaceuticals worldwide. The country has an extremely high disease burden. It is the nation having the highest proportion of tuberculosis sufferers.
- India inherited the weight of maternal, perinatal, and pediatric illnesses, as well as the spread of infectious diseases and the rising burden of non-communicable diseases.
- The number of diseases like diabetes and hypertension that require lifelong treatment is rising. For medication companies, this opens up a sizable domestic market.
- The largest problem facing the Indian pharma/API sector is supplying the expanding demand of this enormous patient population.
- As evidenced by the fact that the Indian pharmaceutical industry, including APIs, is the third largest by volume and the tenth largest by value, India is also a major supplier of safe, high-quality, and affordable pharmaceuticals to the rest of the globe.
- The lower rank by value demonstrates that Indian producers’ pharmaceuticals are more affordable than others. But as governments and international organisations become more aware of the importance of protecting people’s health, the world moves closer to achieving Sustainable Development Goal 3, which is to “Ensure healthy lives and promote well-being for all at all ages by 2030“, and as more and more nations make universal healthcare a priority, the demand for medicines is steadily rising.
- Given the dearth of nations with adequate medical manufacturing capabilities, the pharmaceutical business in nations like India has hurdles in improving their manufacturing.
- Pharmaceuticals have a sizable domestic and international market, but there are several obstacles the business must overcome in order to boost production and export.
- They have to do with laws, both domestic and foreign laws, export policies, environmental laws, tax laws, the financial crunch, and inadequate R&D funding.
- The early expansion of the Indian pharmaceutical sector was built upon a strong domestic API market. However, the current COVID-19 outbreak situation has shown some flaws in the industry.
- Recent years have seen an increase in environmental awareness, especially in the wake of the Paris Climate Change Agreement.
- Pharmaceutical businesses are quite vulnerable in terms of pollution. Effluent treatment and other pollution control methods are mandated by the regulations.
- They are expensive, and a lot of veteran MSME units aren’t even aware of the rules. As a result, it is a problem with technology, money, and management. It is difficult to upgrade the industry to satisfy the necessary criteria of the present and the future.
Any material or combination of materials designed to be employed in the creation of a drug (medicinal) product and which, when utilized in the production of a drug, forms an active component of the drug product.
These compounds are designed to provide pharmacological action or other direct effects in the diagnosis, treatment, mitigation, or prevention of disease, or to alter the structure or function of the body.