New Delhi : The govt is taking steps to produce “high value pharmaceuticals” in the country to reduce import dependency for such critical articles, Union Minister Mansukh Mandaviya said on Tuesday.

Manufacturing of components of high-end medical devices in the country will be another big step in moving towards self reliance, the Union Minister for Chemicals and Fertilisers noted.

“Working on the vision of reducing import dependency through indigenous production, the government is focussing on production of high value pharmaceuticals and high-end medical devices,” he said.

With an objective to enhance India’s manufacturing capabilities and contributing to product diversification towards high value goods in the pharmaceutical sector, 3 different categories of products are being supported under the scheme, viz,

  • Category 1: Biopharmaceuticals; Complex generic drugs; Patented drugs or drugs nearing patent expiry; Cell based or gene therapy drugs; Orphan drugs; Special empty capsules, Complex excipients,
  • Category 2: Bulk drugs (except those 41 eligible products notified under “PLI Scheme for Bulk drugs) and
  • Category 3: Drugs not covered under Category 1 and Category 2 such as Repurposed drugs; Auto immune drugs, anti-cancer drugs, anti-diabetic drugs, anti-infective drugs, cardiovascular drugs, psychotropic drugs and anti-retroviral drugs, including In vitro diagnostic devices (applicable to 5 applicants out of 55 applicants);

The incentives on incremental sales to selected participants under these categories are at varying rate over the years ranging from 10% to 3% (tapering at last two years of the scheme).

Mandaviya said the Department of Pharmaceuticals (DoP) has released the first tranche of incentives under the Product Linked Incentive (PLI) scheme of pharmaceuticals amounting to Rs 166 crore to four selected applicants.

Under the Atmanirbharta initiative of the government, DoP launched the PLI scheme for pharmaceuticals in 2021.

The financial outlay under this PLI scheme is Rs 15,000 crore over a period of six years.

So far, 55 applicants have been selected under the scheme, including 20 Micro, Small & Medium Enterprises (MSMEs).

The financial year of 2022-2023 being the first year of production for the PLI Scheme, DoP has earmarked Rs 690 crore as the budget outlay.

Against the expected investment of Rs 17,425 crore in the pharmaceutical sector over the scheme period, the scheme has garnered an investment of Rs 16,199 crore by these 55 applicants in the first year of implementation itself, the ministry said.

Against the expected employment of 1 lakh over six years scheme period, 23,000 people have been given employment, so far, it added.

The DoP has received an incentive claim of about Rs 544 crore from 15 applicants, it said. Based on the evaluation, Rs 221 crore of claims of incentives from four applicants—Dr Reddy’s Laboratories, Biocon Ltd, Strides Pharma Science Ltd, Premier Medical Corporation Pvt Ltd—were found to be eligible and 75 per cent of this amount (Rs 165.74 crore) have been released, it added.

Remaining incentives are under examination, the statement said. Under the PLI scheme for bulk drugs with a financial outlay of Rs 6,940 crore, the objective is to boost domestic production of 41 select critical bulk drugs in the country.

So far, 51 projects have been selected for the 34 notified bulk drugs, it added. Moreover, a total of 21 applicants have been selected under the PLI scheme for medical devices with a financial outlay of Rs 3,420 crore, it said.