The Department of Pharmaceuticals (DoP) has constituted a five-member technical committee to assist the department for Phase II Production Linked Incentive (PLI) Scheme.
Dr Eswara Reddy, Joint Drug Controller, CDSCO is the Chairman of the constituted technical committee, along with other members, NCL, Pune; Prof Arvind Bansal, NIPER Mohali; Satish Khanna, Chairman, Fullife Healthcare and Srinivas Lanka, Honorary Senior Advisor, Pharmexcil.
Srinivas Lanka, Member- Technical Committee of Phase II PLI Scheme, Honorary Senior Advisor, Pharmexcil, said, “We have already started working on it and so far, we have conducted three meetings in this context, in consultation with the industry stakeholders.”
The key roles of the committee members are:
- To propose principles for inclusion of a drug under different categories of the scheme.
- To recommend drugs which could be approved to be included in the scheme based on a proposed incentive scheme for three categories of pharma goods.
- To also assist the DoP on any other technical issues
An industry observer pointed out, “In PLI 1 where we had so many caveats, the response came from only 83 companies (of around 9000 companies), filing 215 applications. Therefore this scheme needs to be analysed for its success. Earlier, the committee had industry trade association members as part of the committee, which is not seen in part II of the PLI scheme. If the objective is to be met for the proposed scheme; let’s keep the proposed PLI free from all encumbrances. It’s not clear what exactly will be the terms of reference and whether we can’t do without the newly formed technical committee.”
On November 11, the Government gave the approval to introduce the PLI scheme for pharma along with nine other sectors. Under the scheme, three categories of pharma goods are proposed to be incentivised on incremental sales over a period of five years.
2) Complex generic drugs
3) Patented drugs or drugs nearing patent expiry
4) Cell based or gene therapy products
5) Orphan drugs
6) Special empty capsules
7) Complex excipients
9) Other drugs as approved
Active Pharma Ingredients (APIs) /Key Starting Materials (KSMs) and /Drug Intermediaries (Dls)
1) Repurposed drugs
2) Auto-immune drugs, anti-cancer drugs, anti-diabetic drugs, anti-infective drugs, cardiovascular drugs, psychotropic drugs, anti-retroviral drugs
3) In-vitro diagnostic devices (IVDs)
4) Other drugs not manufactured in India
5) Other drugs as approved