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DoP To Frame Guidelines To Set Up Three Mega Bulk Drug Parks

DoP To Frame Guidelines To Set Up Three Mega Bulk Drug Parks


Mumbai, 27 April 2020:

 

The Department of Pharmaceuticals (DoP) is in the process of framing guidelines to set up three mega bulk drug parks at different parts in the country. The Union Cabinet has already approved Rs. 3,000 crore under the scheme for promotion of these bulk drug parks.

 

“We are in the process of framing guidelines basis on which bulk drug parks will be set up in prospective states as the scheme envisages developing three mega bulk drug parks in India in partnership with states. It will also be determined where the parks will be set up based on the guidelines,” according to a senior official associated with the development.

 

DoP has prepared a scheme for development of pharmaceuticals industry with the objective to ensure drug security in the country by increasing the efficiency and competitiveness of domestic pharmaceutical industry with the following sub-schemes like Assistance to Bulk Drug Industry for Common Facility Centre and Pharmaceutical Promotion Development Scheme (PPDS) among others.

 

According to the plan, the scheme has been envisaged for promotion of bulk drug parks to finance common infrastructure facilities in 3 bulk drug parks with financial implication of Rs 3,000 crore for next five years. This Production Linked Incentive (PLI) Scheme is for promotion of domestic manufacturing of critical KSMs/Drug Intermediates and APIs in the country with financial implications of Rs 6,940 crore for the next eight years.

 

Government of India will give Grants-in-Aid to States with a maximum limit of Rs. 1,000 crore per Bulk Drug Park. Parks will have common facilities such as solvent recovery plant, distillation plant, power and steam units, common effluent treatment plant etc. According to the scheme, financial incentive will be given to eligible manufacturers of identified 53 critical bulk drugs on their incremental sales over the base year (2019-20) for a period of 6 years.

 

Out of 53 identified bulk drugs, 26 are fermentation based bulk drugs and 27 are chemical synthesis based bulk drugs. Rate of incentive will be 20% (of incremental sales value) for fermentation based bulk drugs and 10% for chemical synthesis based bulk drugs. A sum of Rs. 6940 crore has been approved for the next 8 years.

 

The scheme is expected to reduce manufacturing cost of bulk drugs in the country and dependency on other countries for bulk drugs. The scheme intends to boost domestic manufacturing of critical KSMs/Drug Intermediates and APIs by attracting large investments in the sector to ensure their sustainable domestic supply and thereby reduce India's import dependence on other countries for critical KSMs/Drug Intermediates and APIs. It will lead to expected incremental sales of Rs. 46400 crore and significant additional employment generation over 8 years.

 

The scheme will be implemented by State Implementing Agencies (SIA) to be set up by the respective State Governments and the target is to set up 3 mega Bulk Drug Parks. The scheme will be implemented through a Project Management Agency (PMA) to be nominated by the Department of Pharmaceuticals. The Scheme will be applicable only for manufacturing of 53 identified critical bulk drugs (KSMs/Drug Intermediates and APIs).

 

Common infrastructure facilities would be created with the financial assistance under the sub-scheme in 3 bulk drug parks. It is expected to reduce manufacturing cost and dependency on other countries of bulk drug in the country.

 

India 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%.

 

While Maharashtra, Gujarat and Karnataka are the front-runners, the Centre has also plans to set up bulk drug parks at Himachal Pradesh, Visakhapatnam, Ahmedabad and Tamil Nadu to boost bulk drug production in the country. Pharmabiz