Bulk Drug Park at a Glance; Read in Detail Here

On 13th October 2022, PM Modi laid the foundation stone of a Bulk Drug Park in the Una district of Himachal Pradesh, where the assembly election is about to start in November. The Prime Minister emphasized that it is a massive day for industrialization and raised the critical focus of his visit to the state as connectivity and education. Also, he pointed out that Himachal has been chosen as one of the states to get a bulk drug park. Let's take a look in detail at Bulk Drug Park as well as other vital points.

What is Bulk Drug?

A bulk drug, also termed active pharmaceutical ingredients (APIs), is the chemical molecule in a pharmaceutical product that lends the product the claimed therapeutic effect. These are the primary ingredients of a drug or medicine. The World Health Organization (WHO) defines bulk drugs or APIs as "Any substance or combination of substances used in a finished pharmaceutical product (FPP), considered to provide in pharmacological activity or else to use for direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease, or to have direct effect in restoring, correcting or modifying physiological functions in human beings."

Varieties of Active Pharmaceutical Ingredients/ Bulk Drugs:

Chemical Synthetic Drugs
Inorganic - Examples - Aluminum hydroxide and Magnesium trisilicate
Organic - Examples - Aspirin, Chloramphenicol, Caffeine, etc.
Natural Chemical Drugs
Biochemical - Examples - Antibiotics
Phytochemical - Examples - Paclitaxel (taxol), Resveratrol

A bulk drug is blended with other crucial agents or solvents to prepare the finished pharmaceutical product (capsule, syrup, or tablet.)

WHAT IS A BULK DRUG PARK?

It is a space with common infrastructure facilities for the exclusive manufacture of APIs or D.I.s, or KSM.
Bulk Drug Park will also have a standard waste management system.
The Park will help reduce dependence on API imports.
It creates a robust ecosystem for Bulk Drug manufacturing in the country and lessens the manufacturing cost significantly.
The park to be developed under the Aatmanirbhar Bharat scheme is expected to encourage domestic manufacturing of bulk drugs to reduce import dependence and to establish a dominant position in the global market by providing easy access to standard testing & infrastructure facilities.

Measures of a Bulk Drug Park Selection

The area used for medicinal purposes shouldn't be less than 1000 acres for all the states except 7000 acres for hill states.
A state will offer only one site along with its calculated cost, feasibility studies, environmental risk review, etc.
Department of Pharmaceuticals-led Project Management Agency (PMA) evaluates the state proposals and forwards them to Scheme Steering Committees for approval.

Why does the Indian Government scheme promote Bulk Drug Parks?

According to data mentioned by the Ministry of Chemicals and Fertilizers, in 2018-19, bulk drug imports accounted for 63 percent of total pharmaceutical imports in the country.
Due to corona pandemic and succeeding lockdowns, Indian pharmaceutical industries faced issues as the imports of APIs were affected.
Due to the halt of bulk drug supply, the government of India brought a scheme called 'Bulk Drugs Park' in March 2020.

How will the promotion of Bulk Drug Park support Indian Pharmaceutical Industry?

The drug manufacturers will easily access world-class common infrastructure facilities (CIF.)
The aid supplied under this scheme is conscious of bringing down the manufacturing sum of bulk drugs.
It will promote self-sustain in pharmaceutical manufacturing and can relate to India's ambition for AtmaNirbhar Bharat.
The bulk drug parks will also raise the competitiveness of the bulk drug industry in India.

Positive Outcome in Health Sector due to Indian Pharma Industry

• 36% lower Disability-Adjusted Life Year (DALY)/per person.
• 100% eradication of Polio.
Positive Economic Outcome in Indian Pharma Industry
• Around 2.7 million employments develop directly or indirectly.
• It has an annual trade surplus of approximately 11 billion US Dollars.
• FDI influx in the pharma industry sum of around 2 billion US Dollars between 2016-2019.

PM Modi on Bulk Drug Park

He said that the state has played a crucial role in making India the number one medicine manufacturer in the world. "The raw materials for medicine manufacturing will be produced in Himachal Pradesh. India's dependency on other countries will decrease significantly."
He further said that the government was providing free treatment expenses up to 5 lakh rupees for the poor and needy through Jan Aushadhhi Kendra under the Ayushman Bharat Scheme. "The Bulk Drug Park will give further strength to the government's campaign to provide quality and affordable medical care to people."

Upcoming zones of Bulk Drug Park

The Bulk Drugs will be established on 1402.44 acres of land at Tehsil Haroli, District Una, Himachal Pradesh
2015.02 acres of land at Tehsil Jambusar, District Bharuch, Gujarat
2000.45 acres of land at K.P. Puram &Kodhada of Thondagi Mandal of East Godavari District, Andhra Pradesh.

The government instructed these states to submit their Detailed Project Reports in the next 90 days to appraise the same and to process the issuance of final approval under the scheme.