Last Updated on November 1, 2021 by The Health Master
The Department of Pharmaceuticals (DoP) has taken important policy decisions in connection with the medical devices industry and held significant meetings with the industry during the month of September, said the department in a monthly report.
Approval for four States: During the month of September, the department has issued in-principle approval to four states i.e. Himachal Pradesh, Uttar Pradesh, Madhya Pradesh and Tamil Nadu under the scheme “Promotion of Medical Devices Park”.
Promotion of Medical Devices Parks: The Union Cabinet has approved the revision in the sub-scheme from ‘Assistance to Medical Device Industry for Common Facility Centre’ to ‘Promotion of Medical Devices Parks‘.
Laboratory facilities: Recognising the need for higher levels of investments for the creation of testing and laboratory facilities, the Department of Pharmaceuticals has notified the scheme “Promotion of Medical Devices Parks” on July 21, 2020.
Under the Scheme, a one-time grant-in-aid will be provided for creation of common infrastructure facilities in selected Medical Device Park proposed by a State Government. The parks will provide common testing and laboratory facilities / centre at one place reducing the manufacturing cost significantly and will help in creating a robust ecosystem for medical device manufacturing in the country.
The total financial outlay of the scheme is Rs. 400 crore. The tenure of the scheme is from FY 2020-2021 to FY 2024-2025.
Proposal by 16 States: Sixteen States / Union Territories submitted their proposals under the scheme. After evaluation of proposals and approval of the Scheme Steering Committee, the Department through letters dated September 24, 2021 conveyed the in-principle approval to the four companies, said the Department in its Monthly Summary.
Funds released: The Department also released the first installment of Rs. 7.49 crore for the project of Andhra Pradesh Medtech Zone Ltd (AMTZ) on September 11 and reviewed the progress of the project for release of second installment of the Grant in Aid in a meeting of the Scheme Steering Committee of the scheme “Assistance to Medical Device Industry for Common Facility Centre”, held on September 30.
Under the Scheme, AMTZ will get a grant of Rs. 25 crore for creation of a common facility centre for superconducting magnetic coils testing and research facility. The SSC approved the second installment of Rs. 7.50 crore during the meeting.
Manufacturing of MRI machines: Upon completion of the project, it would enable testing of superconducting magnets in the country and would lead to manufacturing of MRI machines in the Country.
Minimise regulatory compliance burden: The Department, in partnership with industry organisation FICCI, has compiled a list of various issues faced by the medical devices industry not the regulatory side, during the month through a virtual regulatory round table, as the stated policy of the Government of India is to minimise regulatory compliance burden on business as well as citizens, it said.
Reviewed various issues: Apart from the measures in the medical devices industry, the Department has also held two meetings of the Drugs Coordination Committee during the month and reviewed the following:
- During when the procurement orders placed by States/UTs for Covid drugs buffer stock;
- Adequacy of raw material supply with regard to manufacture of drugs used in Covid-19 treatment;
- New approvals granted by COSCO or State Licensing Authorities;
- Update on monoclonal antibodies licensed for import / manufacture / marketing;
- Export of remdesivir and amphotericin B;
- Imports of tocilizumab;
- Manufacturing and availability of IVIG including coordination with blood banks to boost plasma availability.
Raw material availability: The early effective functioning of buffer operations was prioritised with an emphasis on eliminating / minimising bottlenecks with regard to raw material availability and eliciting active participation of states / UTs and other concerned stakeholders.
Remdesivir: During September, 2021, a total of 55,18,111 vials of remdesivir were recommended for export to DGFT.
Amphotericin B: 2,53,186 vials of amphotericin B were recommended for export to DGFT.
Tocilizumab: Allocation of commercial shipments of tocilizumab is being undertaken jointly by the Department of Pharmaceuticals and ministry of health and family welfare amongst states/UTs to ensure equitable distribution of limited availability of this drug since it was not manufactured in the country and sourced through imports from Mis Roche, Switzerland. On September 14, 2021, allocation of 5,311 patient doses was made from fresh imports/reserve stocks.
Price fixation: The National Pharmaceutical Pricing Authority (NPPA) has fixed retail prices of 23 new medicines, bringing the cumulative figure to 1,621 till September, 2021.
PLI scheme for bulk drugs: Under the production linked incentive (PLI) schemes related to the sector the PLI for Bulk drug has seen 215 applications filed in first round and 24 in second round, of which 42 were approved till the end of September.
PLI scheme for medical devices: PLI for medical devices has seen 28 applications in the first round and 14 in the second round, while 13 have been approved totally till September end. PLI for pharmaceuticals, which has a total of 55 slots, has received a total of 278 applications and all are under examination by the project management agency, the SIDBI.
FDI: The Department had 17 Foreign Direct Investment (FDI) proposals at the beginning of the month and received one more during September. However, it disposed of two applications in September and at the end of the month, it had 16 pending cases.
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