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Gujarat FDCA to set up a dedicated common testing facility at first bulk drugs park at Jambusar in Bharuch
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Shardul Nautiyal, Mumbai
June 19 , 2024
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In a decisive move to enhance drug testing capabilities, the Gujarat Food and Drug Control Administration (FDCA) has recently held discussions with the Industries and Mines Department (IMD), Government of Gujarat on modalities and requirements to setup a dedicated common drug testing facility in the country’s upcoming first bulk drugs park at Jambusar in Bharuch district, Gujarat. IMD has demarcated 2,200 acres of land for the country’s first bulk drug park at Jambusar.
Setting up of this park at Jambusar will boost more than 300 industries which are mostly SMEs.
This closely follows the submission of a detailed project report (DPR) to the government. Estimated to cost Rs. 2,200 crore, the bulk drugs park in Gujarat will be set up as per the guidelines of the scheme “Promotion of Bulk Drug Parks” issued by the Department of Pharmaceuticals (DoP) on July 27, 2020, to boost domestic production of bulk drugs.
DoP had approved the proposals for bulk drug parks in Gujarat, Himachal Pradesh and Andhra Pradesh based on federal competition among all the states in the country in December 2022.
“The testing lab will be equipped with the latest thermal analytics, rapid microbiological tools, analytical equipment, and chemistry based analytical testing modalities to check the purity and potency of the bulk drugs in an effective manner,” informed Gujarat FDCA commissioner Dr H G Koshia.
Under the “Promotion of Bulk Drug Parks” scheme, the Central government is offering a financial grant-in-aid of Rs. 1,000 crore to develop common infrastructure facilities of the bulk drug parks. The common infrastructure facilities will include a common effluent treatment plant, a common solvent storage system, solid waste management, storm water drains, a safety and hazardous operations audit centre.
Gujarat Industrial Development Corporation (GIDC), a wholly owned corporation of the Gujarat government, has been designated as the State Implementing Agency (SIA) for developing the park at Jambusar.
The Central government is implementing the scheme for the promotion of bulk drug parks with the aim of achieving drug security and reducing dependence on imports. The scheme intends to boost domestic manufacturing of identified KSMs, drug intermediates and APIs by attracting large investments in the sector and thereby reduce India’s import dependence in critical APIs.
Under the Scheme, financial incentives shall be given based on sales made by selected manufacturers for 41 products, which cover all the identified 53 APIs. Financial incentive under the scheme shall be provided on sales of 41 identified products for six (06) years at specified rates.
For fermentation-based products, incentive for FY 2023-24 to FY 2026-27 would be 20%, incentive for 2027-28 would be 15% and incentive for 2028-29 would be 5%. For chemical synthesis-based products, incentive for FY 2022-23 to FY 2027-28 would be 10%.
Gujarat contributes about 28% of the country’s pharma exports of USD 25 billion and 30-31% of the domestic market that is pegged at another USD 25 billion. The pharma sector of the country has been hit by an unprecedented rise in the input costs for the past one and a half years.
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