What is a bulk drug park?

Context:

Tamil Nadu should work with Centre to set up a bulk drug pharma park: panel The Rangarajan committee, constituted by the Tamil Nadu government to study the impact of the COVID19 pandemic on its economy, has identified medical devices manufacturing and pharmaceuticals, along with biotechnology, as emerging sectors.

The committee, which submitted its report to the government in September, suggested that the State work with the Union government to set up a bulk drug pharma park expeditiously in a coastal area near Chennai.

Himanchal Pradesh state government has also identified around 1,400 acres in Una district and sent a proposal to the Centre seeking grant to set up a bulk drug park.

Himanchal Pradesh is one of the states vying for the allotment of a bulk drug park under a central government scheme announced earlier this year for setting up three such parks across the country. The state government has identified around 1,400 acres in Una district and sent a proposal to the Centre seeking grant to set up a bulk drug park there, Chief Minister Jai Ram Thakur informed a group of drug manufacturers recently.

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.

What are KSMs and DIs?

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 APIs, DIs and KSMs.

This year, drug manufacturers in India suffered repeated setbacks due to disruption in imports. In January, 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. All these factors pushed the Indian government to call for greater self-reliance across all industries, and in June, the department of pharmaceuticals announced a scheme for the promotion of three bulk drug parks in the country.

What will a bulk drug park look like, and what does the scheme 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 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. 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.

How will the Centre select the three parks?

Several states including Andhra Pradesh, Maharashtra, Gujarat, Haryana, Punjab, Tamil Nadu and Telangana have expressed interest in the scheme, and are likely to send their respective proposals. 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. The proposals should contain the estimated cost, feasibility studies, environmental risk assessment etc. A project management agency, nominated by the department of pharmaceuticals, will examine these proposals and make recommendations to a scheme steering committee, which will then approve the proposals.