In the year 2023, various programs and initiatives were implemented in the Department of Pharmaceuticals. A major initiative of Government of India 'Pradhan Mantri Bhartiya Janaushadhi Pariyojana' has achieved his target of opening 10000 retail outlets to provide quality generic medicines at affordable prices to the poor and underprivileged and PLI scheme to strengthen India's manufacturing capacity in the pharmaceutical sector by increasing investment and production. Apart from this, the department also laid special emphasis on promoting domestic manufacturing of medical equipment and strengthening the pharmaceutical industry.

1. Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP)

Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP) is a flagship scheme of the Department whereby quality generic medicines are made available at affordable prices to all through dedicated outlets known as Pradhan Mantri Bhartiya Janaushadhi Kendras (PMBJK). The Scheme is being implemented through the Pharmaceuticals & Medical Devices Bureau of India (PMBI), an autonomous society under the Department of Pharmaceuticals. As on 30.11.2023, 10,006 Pradhan Mantri Bhartiya Janaushadhi Kendras (PMBJKs) have been opened across the country.

Objectives of the Scheme is to make available quality medicines and surgical items at affordable prices for all and thereby reduce out of pocket expenditure of consumers/patients and popularize generic medicines among the masses.

Product basket of PMBJP comprises 1965 medicines & 293 surgical equipment covering all major therapeutic groups such as Anti-infectives, Anti-diabetics, Cardiovasculars, Anti-cancers, Gastro-intestinal medicines, etc., which are available for sale through these kendras. In the year 2023, 206 medicines & 13 surgical equipment have been added in the product basket.

Suvidha Sanitary Napkins

In order to ensure easy availability of the menstrual health services at affordable prices for women, Jan Aushadhi Suvidha Sanitary Napkins at Rs.1/- per pad are being made available through PMBJKs, across the country. Till 30.11.2023, over 47.87 crore Jan Aushadhi Suvidha Sanitary Pads have been sold through these Kendras. In 2023, over 15.87 crore Jan Aushadhi Suvidha Sanitary Pads have been sold till 30.11.2023.

Savings to the citizens

In 2022-23, PMBI registered sales of Rs.1235.95 crore which led to savings of approximately Rs.7416 crore to the citizens. In the current financial year 2023-24, till 30.11.2023, PMBI has made sales of Rs.935.25 crore, which has led to savings of approximately Rs.4680 crore to the citizens. Thus, in all, approximately Rs.23,000 crore have been saved under this Pariyojana in last 9 years.

Progress Report

Financial Year	Number of PMBJP Kendras functional		Sales at MRP Value in Rs. crore
	Yearly addition	Cumulative
2022-23	694	9304	1235.95
2023-24 (As on 30.11.2023)	702	10006	935.25

Steps taken for increasing viability of kendras

1. Product basket is continuously expanded to provide complete range of medicines for increasing footfall to the Kendras, covering almost all chronic and acute disease conditions.
2. Department has taken various steps to ensure market expansion. State Health departments and associated government authorities have been requested to open Jan Aushadhi Stores in various government hospitals by providing rent free spaces to private individuals.
3. To ensure awareness among masses, various media platforms like print, outdoor, TV & social media, etc. are being used regularly. Government is also adopting an integrated approach for spreading awareness about PMBJP with State Governments. Promotion workshops are also being organized across India with stores owners, doctors and various important dignitaries.

Jan Aushadhi Diwas Celebration (7^th March 2023):

The 5^th Jan Aushadhi Diwas was celebrated on 7th March 2023 with the theme “janaushdhi achchi bhi aur sasti bhi”. The week long awareness programme started with Jan Aushadhi Jan Chetna Abhiyan on 1^st March 2023 and ended with the celebrations of Jan Aushadhi Diwas on 7^th March 2023, with grand events conducted at State / UT level across the country.

During this week long celebration, various events were organized by the PMBI at different locations across the country covering all States/UTs. All activities and celebrations have been conducted in close coordination with PMBJK owners, beneficiaries, State/UT officials, Public Representatives, Doctors, Health Workers, Nurses, Pharmacists, Jan Aushadhi Mitras and other stakeholders.

 

 

 

2.       Production Linked Incentive (PLI) scheme for promotion of domestic manufacturing of critical Key Starting Materials (KSMs), Drug Intermediates (DIs) and Active Pharmaceutical Ingredients (APIs) in India:

The objective of Production Linked Incentive (PLI) scheme for promotion of domestic manufacturing of critical Key Starting Materials (KSMs)/ Drug Intermediates and Active Pharmaceutical Ingredients (APIs) in India is to promote domestic manufacturing of 41 identified bulk drugs to address their high import dependence. The total outlay of the scheme is Rs 6,940 crore and the scheme duration is from 2020-21 to 2029- 30. The scheme provides for financial incentive for six years to eligible manufacturers of 41 bulk drugs on their incremental sales over the base year. For fermentation based eligible products, rate of incentive for the first four years (2023-2024 to 2026-2027) is 20%, for the fifth year (2027-28) it is 15% and for the sixth year (2028-2029) it is 5%. For chemical synthesis products, rate of incentive for entire six years (2022-2023 to 2027-2028) is 10%. Industrial Finance Corporation of India (IFCI) Ltd. is the Project Management Agency (PMA) for the scheme.

A total 249 applications across all four categories of products were received. Out of 249 applications, 48 applications have been approved with committed investment of Rs.3,938.57 crore and expected employment generation of around 9,618 persons. With the successful implementation of this Scheme, it is expected that in the coming years, the import dependence in the notified bulk drugs will get reduced over the implementation period of the scheme.

Progress made under the scheme as of September 2023 is as follows:

Out of 48 approved projects, 27 projects have been commissioned. Investment of Rs.3,063 crore has been grounded and employment for 2,777 persons has been generated. The sales made by the commissioned projects is worth Rs.817.33 crore which includes exports of Rs.252.62 crore.

FY 2022-23 was the first year of performance/sales, and incentive amount of Rs.4.34 crore was released to the applicants, based on achieving the eligibility criteria for Quarterly/Half-yearly incentive claims and verification by the Project Management Agency.

Glimpse of some of the commissioned projects:

Plant: Meghmani LLP	Product: Para Amino Phenol
Plant: Centrient Pharmaceuticals India (P) Ltd	Product: Atorvastatin

 

3.       Production Linked Incentive Scheme for Promoting Domestic Manufacturing of Medical Devices:

 

Production Linked Incentive (PLI) scheme for promoting domestic manufacturing of medical devices has a financial outlay of Rs.3420 crore. The tenure of the scheme is from 2020-21 to 2027-28. The objective of the scheme is to boost domestic manufacturing and attract large investments in the Medical Device sector. Under the Scheme an incentive of 5% is given on incremental sales of medical devices manufactured in India and covered under four target segments of the scheme, to eligible domestic manufacturers, for a period of five years. IFCI Ltd. is the Project Management Agency for the scheme.

A total 64 (42 Category –A and 22 Category –B) applications across all four categories of products were received. Out of 64 applications, 26 applications (19 Category –A and 7 Category –B) have been approved with committed investment of Rs.1,330.44 crore and expected employment generation for around 7,950 persons.

Progress made under the scheme as of September 2023 is as follows:

Out of 26 approved projects, 16 projects have been commissioned and manufacturing of 39 medical devices has started. Investment of Rs.879 crore has been grounded and employment generated for 4,546 persons. The sales made by the commissioned projects is worth Rs.3251.76 crore which includes exports of Rs.1654.09 crore.

FY 2022-23 was the first year of performance/sales, and incentive amount of Rs.12.80 crore was released to the applicants based on achieving the eligible criteria for Quarterly/Half-yearly incentive claims and verification by the Project Management Agency.

 

4.       Production Linked Incentive Scheme for Pharmaceuticals:

PLI Scheme for pharmaceuticals is being implemented with an objective of enhancing India’s manufacturing capabilities by increasing investment and production in the sector and contributing to product diversification to high value goods in the pharmaceutical sector. The total outlay of the scheme is Rs.15,000 crore and the scheme duration is from 2020-2021 to 2028-29.

Under the scheme, financial incentive is provided for production of identified products under three product categories. Category 1 includes drugs such as - bio-pharmaceuticals, complex generics, patented drugs or drugs nearing patent expiry, orphan drugs etc., Category-2 includes active pharmaceutical ingredients, key starting materials, drug intermediates etc., and Category-3 includes auto-immune drugs, anti-cancer drugs, anti-diabetic drugs, anti- infective drugs, cardiovascular drugs, psychotropic drugs, anti-retroviral drugs, In-vitro devices etc. These products are expected to give an impetus to innovation, R&D and product diversification of Indian Pharmaceutical industry. In addition, investment by the anchor industries of the pharmaceutical sector shall play a vital role in development and growth of MSMEs down the value chain in the forthcoming years.

Scheme provides for financial incentives on incremental sales (over base year) of pharmaceutical goods and in-vitro diagnostic medical devices to selected applicants, depending upon the threshold investments and sales criteria to be achieved by the applicants, at the rate of 10% for FY 2022-23 to FY 2025-26, 8% for FY 2026-27 and 6% for FY 2027-28 for product categories 1 & 2. The incentive for product category 3 is at the rate of 5% for FY 2022-23 to FY 2025-26, 4% for FY 2026-27 and 3% for FY 2027-28. Small Industries Development Bank of India (SIDBI) is the Project Management Agency for the Scheme.

Under the Scheme, 55 applicants have been selected, which includes five applicants of In-vitro Diagnostics (IVD) devices with committed investment of Rs.17,275 crore.

Progress made under the scheme as of September 2023 is as follows:

Investment worth Rs.25,813 crore has been grounded and employment for 56,171 persons have been generated. The sales made by the selected applicants is worth Rs.1,16,121 crore which includes exports of Rs.75,141 crore. The scheme envisages manufacturing of specialized category of pharmaceuticals/ IVD devices.

FY 2022-23 is the first year of performance/sales, and incentive amount of Rs.915 crore has been released to the applicants based on achieving the eligible criteria for Quarterly/Half-yearly/Annual incentive claims and verification by the Project Management Agency.

 

5.       Strengthening of Pharmaceutical Industry (SPI):

Department of Pharmaceuticals, implements the scheme “Strengthening of Pharmaceutical Industry” (SPI), with a total financial outlay of Rs.500 crore. The implementation period of the scheme is from FY 21-22 to FY 25-26. The scheme aims to provide support to existing Pharma clusters and MSMEs across the country to improve their productivity, quality and sustainability to strengthen the existing infrastructure facilities in the Pharma MSME clusters. SIDBI has been appointed as the Project Management Consultant (PMC) for the SPI scheme.

This Scheme is a Central Sector Scheme and comprises the following sub-schemes:

i. Assistance to Pharmaceutical Industry for Common Facilities (API-CF)

ii. Pharmaceutical Technology Upgradation Assistance Scheme (PTUAS)

iii. Pharmaceutical & Medical Devices Promotion and Development Scheme (PMPDS)

i. Assistance to Pharmaceutical Industry for Common Facilities (API-CF), to strengthen the existing pharmaceutical clusters’ capacity for their sustained growth by creating common facilities. This will not only improve the quality but also ensure the sustainable growth of clusters.

ii. Pharmaceutical Technology Upgradation Assistance Scheme (PTUAS) to facilitate Micro, Small and Medium Pharma Enterprises (MSMEs) of proven track record to meet national and international regulatory standards (WHO-GMP or Schedule-M), interest subvention or capital subsidy on their capital loans will be provided, which will further facilitate the growth in volumes as well as in quality; and

iii. Pharmaceutical & Medical Devices Promotion and Development Scheme (PMPDS) to facilitate growth and development of Pharmaceutical and Medical Devices Sectors through study/survey reports, awareness programs, creation of database, and promotion of industry.

Under the sub scheme Assistance to Pharmaceutical Industry for Common Facilities (API-CF) of Strengthening of Pharmaceutical Industry (SPI) Scheme, application window was opened for inviting applications for project proposals. Accordingly, total 20 applications/project proposals were received from Seven States and Union Territories. Out of 20 applications/project proposals, 17 applications/project proposals were found eligible. As on 30.11.2023, 5 projects have been given final approval, 3 projects have been given in-principle approval.

Under Sub-Scheme Pharmaceutical Technology Upgradation Assistance Scheme (PTUAS) promotional outreach events were held in 11 States and UTs. As on 30.11.2023, 2 projects have been given final approval for capital subsidy on loan.

Under Sub-Scheme Pharmaceutical & Medical Devices Promotion and Development Scheme (PMPDS), as on 30.11.2023, 8 studies have been completed, 6 studies are under finalization. Also 10 events/workshops organized under this Scheme including 2 mega events i.e. “India Pharma 2023 and India Medical Device 2023” and “India MedTech Expo 2023” were organized.

6.       India Pharma 2023 and India Medical Device 2023:

Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers, Government of India, in association with Federation of Indian Chambers of Commerce & Industry (FICCI) organized the 8^th edition of the International Conference on Pharmaceuticals & Medical Devices Industry, INDIA PHARMA 2023 & INDIA MEDICAL DEVICE 2023 on May 26 and 27, 2023 at The Ashok, New Delhi. The Union Minister for Chemicals and Fertilizers Dr. Mansukh Mandaviya inaugurated the Conference in the presence of Shri Bhagwanth Khuba, Minister of State for Chemicals & Fertilizers.

Hon’ble Minister for Chemicals and Fertilizers launched the National Medical Devices Policy, 2023, as well as the Export Promotion Council for Medical Devices. He also launched a new scheme named ‘Assistance for Medical Devices clusters for Common Facilities(AMD-CF) with the objective to strengthen or establish common infrastructure facilities in the medical devices clusters by establishing testing facilities for medical devices.

The annual flagship conference was conducted over two days – 26^th May 2023 dedicated for Indian Medical Device sector on the theme "Sustainable MedTech 5.0: Scaling and Innovating Indian MedTech," and 27^th May 2023 dedicated for the pharmaceutical sector on the theme "Indian pharma industry: Delivering Value through Innovation.

Over 100 CEOs of the pharmaceutical and medical device industries participated in several thematic sessions during the two days, bringing participation from all over the world to the event. Several dignitaries attended the event including members of Industry, NITI Aayog, Secretaries of Departments of Pharmaceuticals, Health, DPIIT & Higher Education, Chairman NPPA, Senior officials of MeitY, MoEFCC, BIS, AERB, National Bio-pharma Commission, Drug Controller General of India, IIT Delhi, IIT Kanpur, NIPER Mohali, BIRAC, Healthcare Sector Skill Council.

India MedTech Expo (IMTE) 2023: India MedTech Expo (IMTE) 2023, 1^st edition, was organized by the Department of Pharmaceuticals, from 17^th-19^th August 2023 at Helipad Exhibition Center, Gandhinagar, with the theme “India: The Next MedTech Global Hub” Future of Devices, Diagnostics and Digital. The event showcased the strength and potential of Indian Medical Devices ecosystem. Some of the major features of the event are as below:

1. The Event brought all stakeholders on one platform, creating opportunities to network and explore collaborations for sector’s growth in India.
2. In the Event, more than 4000 Buyer-Selller meetings were organized and more than 10000+ visitors visited EXPO-2023.
3. The Expo witnessed large participation from Global and Indian companies including MSMEs, Startups, Academic and Research Institutions, State Governments, Central and state procurement agencies, Regulatory Agencies etc.

 

7.       Assistance to Medical Device Clusters for Common Facilities (AMD-CF):

The Standing Finance Committee on 20.03.2022 approved the scheme Assistance to Medical Device Clusters for Common Facilities (AMD-CF) scheme. The Scheme has provision for assistance to 12 clusters and 12 testing labs. The total financial outlay of the scheme is Rs.300 crore. The tenure of the scheme is from FY 2023-24 to FY 2025-26.

AMD-CF Scheme aims to strengthen medical device clusters by providing financial assistance for setting up new testing laboratories for medical devices ensuring quality and sustainable growth for the sector.

The guidelines were issued on 09.05.2023. SIDBI has been appointed as Project Management Agency (PMA) for implementation of Scheme.

 

8.       Scheme for Promotion of Bulk Drug Parks:

To promote setting up of bulk drug parks in the country, a scheme called “Promotion of Bulk Drug Parks” has been approved by Union Cabinet on 20^th March, 2020.The objective is to provide world class common infrastructure facilities to units located in the parks which will help in significantly bringing down the manufacturing cost of bulk drugs and thereby make India self-reliant. This will increase the competitiveness of the domestic bulk drug industry as well as help to minimize country’s dependence on imports.

Under the scheme, financial assistance would be provided for creation of Common Infrastructure Facilities (CIF) in any upcoming Bulk Drug Park promoted by State Government/State Corporation.

The total financial outlay of the scheme is Rs.3000 crore. The tenure of the scheme is from FY 2020-2021 to FY 2024-2025. Financial assistance to a selected Bulk Drug Park would be 70% of the project cost of common infrastructure facilities. In case of North Eastern States and Hilly States (Himachal Pradesh, Uttarakhand, Union Territory of Jammu & Kashmir and Union Territory of Ladakh) financial assistance would be 90% of the project cost. Maximum assistance under the scheme for one Bulk Drug Park would be limited to Rs.1000 crore.

Proposals from 13 States were received under the scheme and after evaluation of all the proposals, Gujarat, Himachal Pradesh and Andhra Pradesh were selected for providing grant-in-aid for creation of common infrastructure facilities in the proposed Bulk Drug Park. First instalment was released to all three selected states.

9.       FDI performance in pharmaceutical sector:

Pharmaceutical is one of the top ten attractive sectors for foreign investment in India. 100% foreign investment is allowed under automatic route in Medical Devices. Foreign investments in pharmaceuticals in greenfield projects are allowed upto 100% under the automatic route and for brownfield pharmaceutical projects, foreign investment beyond 74% to upto 100% Government approval is required.

After abolition of Foreign Investment Promotion Board (FIPB) in May 2017, the Department of Pharmaceutical has been assigned the role to consider the foreign investment proposals under the Government approval route. Apart from this, the Department considers all FDI proposals of pharmaceutical sector and medical devices sector arising out of Press Note 3 of 2020 dated 17.04.2020 wherein investors/ultimate beneficiaries in the proposals are from the countries sharing land border with India.

FDI inflows in pharmaceutical sector (in both pharmaceuticals and medical devices) was Rs.19,077 crore in the financial year 2022-23. During current financial year of 2023-24 from April 2023 to September, 2023, FDI inflows has been Rs.4,456 crore. Further, the Department of Pharmaceuticals has approved 6 FDI proposals worth Rs.9,848 crore for brownfield projects during 1^st April, 2023 to 30^th November 2023.

 

10.     National Institutes of Pharmaceutical Education and Research (NIPERs):

There are seven National Institutes of Pharmaceutical Education and Research (NIPERs) under the aegis of the Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers. These institutes of national importance are located at Mohali, Ahmedabad, Guwahati, Hajipur, Hyderabad, Kolkata and Raebareli. According to the 2023 National Institutional Ranking Framework (NIRF) rankings issued by the Ministry of Education in India, five of these seven NIPERs were ranked within the top 20, with two of them securing positions within the top ten ranks. NIPER Hyderabad has achieved the top rank in the 'Pharmacy' category.

Since its inception, more than 8704 students have passed out from these NIPERs, who are working in the industry as well as in R&D and academic intuitions. During the current calender year, there has been an intake of 1525 MS & PhD students across the seven NIPERs. As part of academia-industry exchange, NIPERs have signed more than 278 MOUs with Industries and other academic institutions, filed more than 395 patents of which signing of 24 MoUs and filing of 31 patents were achieved during the current calender year. NIPERS have published more than 7,325 research papers in various reputed journals so far and out of this, 596 research papers have been published in the current year.

The construction of the campus of Guwahati has been completed. In the case of NIPER Ahmedabad, more than 90% of construction is complete. The construction of campuses of the other four NIPERs at Hajipur, Hyderabad, Kolkata and Raebareli has started recently.

Based on the funds provided, all NIPERs have since set up state-of-the-art laboratories. Improved infrastructure and other facilities have helped NIPERs perform well in the National Institutional Ranking Framework (NIRF) rankings declared by the Department of Higher Education, Ministry of Education every year.

The Department of Pharmaceuticals in collaboration with NIPERs has undertaken various new initiatives in 2023 to promote R&D and Innovation, a few of them are as follows:

(i) National Policy on Research & Development and Innovation in Pharma -MediTech Sector in India’ The Cabinet approved the National Policy on Research & Development and Innovation in the Pharma-MediTech Sector in India in its meeting held on 25.07.2023. The Policy was notified on 18.08.2023. The Policy was launched by Hon'ble Minister for Chemicals and Fertilizers on 26.09.2023.

(ii) Scheme for Promotion of Research & Innovation in Pharma sector (PRIP): Cabinet in its meeting held on 25.07.2023 has approved the Scheme for Promotion of Research and Innovation in Pharma-MediTech (PRIP) with an outlay of Rs.5000 crore for a period of 5 years i.e., 2023-24 to 2027-28. The Scheme was notified on 17.08.2023. The Scheme was launched by Hon'ble Minister for Chemicals and Fertilizers on 26.09.2023.

(iii) Human Resource Development in Medical Devices Sector: A new scheme on ‘Human Resource Development in Medical Devices Sector’ has been approved with an outlay of Rs.480 crore for a period of 3 years under which financial assistance will be provided to government institutions for running multidisciplinary dedicated courses in medical devices.

 

Achievements of the 7 NIPERs during the current year are as follows:

1. NIPER-Ahmedabad has been awarded the prestigious BSCIC certificate for Quality Management, reaffirming its commitment to providing the highest quality education and research to its students and stakeholders.

2. NIPER-Ahmedabad has been recognized with the distinguished BSCIC certificate for Medical Devices, demonstrating its dedication to providing exceptional education and research in the field of medical devices to its students and stakeholders

 

3. Mentorship session organized by BioNEST NIPER Guwahati Incubation Centre for the entrepreneurs of Northeast on 20th April 2023
4. Biomedical Metrology Training program conducted by NIPER Guwahati on 27th & 28th July 2023.
5. NIPER Raebareli organized a session on Biotechnology Ignition Grant-22 in which presentation was made by Dr. Aatmeeyata from Start-up Incubation and Innovation Centre, IIT Kanpur on 13 January 2023.

6. NIPER Raebareli signed the MoU for joint research and academic collaboration with CSIR- Central Drug Research Institute, Lucknow (CDRI, Lucknow) on 20 February 2023.
7. One-day International Symposium on “Drug Discovery & Development Interface” was organized by the Department of Pharmacology & Toxicology, NIPER Raebareli on 1 February 2023.

 

8. National Institute of Pharmaceutical Education and Research, Raebareli organized a one-day symposium on "Recent Trends and Future Prospects in Biological Sciences".
9. National Institute of Pharmaceutical Education and Research, Raebareli had organized “One Day hands-on training on HPLC” under Scientific Social Responsibility (SSR) sponsored by the Science and Engineering Research Board (SERB) and in collaboration with Agilent India Pvt Ltd on 04 July 2023.
10. National Institute of Pharmaceutical Education and Research, Raebareli organized a 5-day “Certificate Course and Training” on “Design and Characterization of Nanomaterials” from 17th–21th July, 2023.
11. NIPER Raebareli has signed MoU with AIIMS, Raebareli to collaborate on joint research and teaching activities on 07-08-2023. This MoU will promote knowledge sharing between the two Institutes of national importance.

12. NIPER Mohali conducted an Ayurveda Heath camp in association with Yukti Herbs, a multi-speciality Ayurveda and Panchakarma Centre, Mohali, under the theme of Health and Wellness to mark the Azadi Ka Amrit Mahotsav.

13. NIPER Mohali organized for Educating/Training of students and personnel of small and medium pharmaceutical industry on HPLC.

14. NIPER Mohali organized a Seminar on small molecule -TB drug discovery.

 

• xv. NIPER Mohali organized a Seminar on “National Intellectual Property Awareness (NIPAM)- Role in Pharmaceutical Sciences”

16. NIPER Mohali organized a one-week training under ITEC Programme entitled “Developing Training and Capacity Building Program on Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP).
17. NIPER Mohali conducted a Soft skill training programme for students enrolled in various post-graduate degree programmes. The training sessions were conducted by distinguished professionals.
18. NIPER Mohali conducted a Workshop on “Pharmaceutical Statistics, Design of Experiment control charts, lean Methodologies, process improvement, shelf life extrapolation”. Through this workshop, students were exposed to the industrial perspective of statistics. Various topics covered were Pharmaceutical Statistics, Design of experiment/ QbD, ICH Q8 / Q9 / Q10, Control charts /Process capability, Lean methodologies, Process improvement and Shelf life extrapolation.
19. NIPER Hajipur conducted a National Symposium on Strategies for Impediment of Emerging Infectious Diseases.

• xx. NIPER Hajipur conducted a 4-day onsite application workshop on LC- HRMS-based metabolomics and a 2-day national Training Program on Materiovigilance.

21. NIPER Hajipur conducted 1st international meeting on cancer & immunity employing transdisciplinary approaches.

22. NIPER Hajipur has created an ISO 7 (Class 10000) clean-room facility and is developing alternatives to animal models such as 3D in vitro models (organoids, organotypics, spheroids and organ-on-a-chip) as a platform for evaluating novel model’s therapies for unusual genetic and neurological disorders.
23. NIPER Hyderabad organized a three-month Student Training Program on Quality Control and Quality Assurance in Pharma Industry. Certificates were awarded to the students on their successful completion of the training program.

 

 

24. NIPER Hyderabad signed the Tripartite Memorandum of Understanding with M/o Youth Affairs and Sports and FSSAI to establish the nutritional supplement testing capacity at NIPER Hyderabad.
25. NIPER Hyderabad has secured 1st Position under the Pharmacy category in NIRF India Rankings 2023.

26. NIPER Hyderabad organized “PHARMACON-2023”- An International Conference on New Horizons in Drugs, Devices & Diagnostics at Kanha Shanti Vanam, Hyderabad during 14-16th Sept 2023.

 

 

27. NIPER Kolkata has received a project for Efficient Process Development Strategies for Prevalent “Rare Disease” Drugs to address Duchenne Muscular Dystrophy (DMD) such as Exondys51, Eliglustat and Tezacaftor with a fund of Rs.15 crore from the Department of Science & Technology, New Delhi.
28. NIPER Kolkata is collaborating with hospitals such as CNCI, Kolkata for developing patient derived cancer organoids for the purpose of anticancer drug sensitivity screening as well as for drug discovery studies.
29. NIPER Kolkata conducted International Symposium On “Recent Advances in Cancer Therapeutics”.
30. NIPER Kolkata organized an “International Conference on Chitosan & 10th Indian Chitin Chitosan Symposium on December 8th – 9th, 2023.

Summary of DoP G20 Events

During the G20 Indian Presidency's Health Track, the Department of Pharmaceuticals (DoP) took charge of organizing and spearheading a series of events, held both in physical and virtual formats. On March 24, 2023, the department organized a webinar on the theme "Collaborative Research on Therapeutics," as part of Business-20 (B-20), followed by organizing a co-branded Event with FIND-UNITAID on the theme - “Expanding Regional Manufacturing Capacity for Diagnostics” on 16^th April, 2023 in Goa as part of 2^nd HWG (Health Working Group). Further, a virtual webinar on the Science-20 (S20) was also organized in collaboration with INSA on April 18, 2023.

Additionally in 3^rd HWG Department organized a series of events including a co-branded event with PATH with the Theme “Building consensus for future health emergencies prevention, preparedness, and response” on 3^rd June, and a side event on “Strengthening Global Collaboration on Research and Development in Medical Countermeasures (MCMs) (Diagnostics, Vaccines, and Therapeutics)” on 5^th June, which saw a participation of G20 member countries, 10 invited states, and 22 international organization among others. A series of field visits were planned for G20 delegates to ICMR-NARFBR & Bharat Biotech in Genome Valley in Hyderabad to exemplify the innovative strength and resilient manufacturing capacities of the Indian pharmaceutical industry along with organizing an industrial exhibition jointly with MoHFW & CII which featured over 40 exhibitors with representations from both industry and academia.

In 4^th HWG Deputies and Ministers Meeting, the Department engaged in bilateral meetings with 14 nations and organizations in Gujarat and Delhi. Additionally, Department organised strategic field visits to Zydus Manufacturing centre and Torrent R&D Centre in Ahmedabad. Later Hon’ble Union Minister for Chemicals and Fertilizers (HMCF) inaugurated PMBJK (Pradhan Mantri Jan Aushadhi Kendra) in Gujarat. Furthermore, DoP with FICCI organized a cobranded event- Med-Tech Expo, showcasing evolving medical technologies in India with a central theme 'India: The Next MedTech Global Hub – Future of Devices, Diagnostics, and Digital' which was inaugurated by Hon’ble HMCF and saw visits from G20 delegates including Health Minister’s from Australia, Japan, Mauritius in addition to hosting Industry Interaction with Indonesian Delegation. The success of these events was underscored both in New Delhi Leader’s Declaration and Modi-Biden Joint Statement where opportunities for deeper collaboration to secure, de-risk, and strengthen pharmaceutical supply was acknowledged.

 

11.     National Pharmaceutical Pricing Authority (NPPA):

The National Pharmaceutical Pricing Authority (NPPA), an independent body of experts in the Ministry of Chemicals and Fertilizers, Department of Pharmaceuticals was constituted by the Government of India vide resolution published in the Gazette of India No. 159 dated 29.08.97. The functions of NPPA, inter-alia, includes fixation and revision of prices of scheduled formulations under the extant Drugs (Prices Control) Order (DPCO), as well as monitoring and enforcement of prices. NPPA also provides inputs to Government on pharmaceutical policy and issues related to affordability, availability and accessibility of medicines.

Followings are the major achievement and initiatives for the period of January to December, 2023:

Fixation of Ceiling Price of drugs: NPPA fixes the ceiling price of formulation listed in Schedule-I of DPCO, 2013. Under the market-based approach adopted in DPCO, 2013. NPPA has fixed the ceiling prices of 915 formulations (700 formulations under NLEM 2022 & 215 formulations under NLEM 2015) under DPCO, 2013 till date. Out of these 700 formulations fixed under NLEM, 2022, ceiling prices for 581 formulations have been fixed in current calendar year. The fixation of ceiling prices of scheduled formulations listed in NLEM 2022 has enabled savings of Rs.3588 crore to the consumers.

Price Revision of Anti-Cancer Drugs under NLEM,2022: As on date, ceiling prices of 131 anti-cancer formulation (including palliative care) are effective. There has been an estimated annual savings of around Rs.293.29 crore on account of fixation ceiling prices of anti-cancer formulation under NLEM, 2022.

Fixation of Retail Price of drugs: NPPA fixes the retail price of 'new drugs' as per DPCO, 2013 which are applicable only to the applicant manufacturing/ marketing companies. NPPA notified retail prices of around 2607 ‘new drugs’ as on date. Out of these retail prices of 411 new drugs have been fixed in current calendar year. In addition to this, retail prices of 19 new drugs have been approved by the Authority in 119th meeting held on 15.12.2023, however, notification in this regard is to be issued.

Exemptions granted under Para 32 of DPCO, 2013: During the FY 2023-24 till 15.11.2023, NPPA has granted exemption under Para 32(i) of DPCO, 2013 to three companies as under:

 

i.        Exemption granted under para 32 (i) to M/s Troikaa Pharmaceuticals Limited for the formulation “Paracetamol Injection (Intramuscular) 250mg/ml, 2ml notified vide S.O. 3561 (E) dated 08.08.2023

ii.       Exemption under Para 32 (i) & (ii) of DPCO 2013 granted to M/s Cadila Pharmaceuticals Limited for their product Cholecalciferol Aqueous Injection 6,00,000 IU/2ml (Vitamin D3 Injection)” notified vide S.O. 4662(E) dated 25.10.2023

iii.      Exemption granted under para 32 (i) of DPCO 2013 to M/s Panacea Biotec Limited for their product EasyfourPol (DTwP-Hib-IPV) Vaccine notified vide S.O. 4661 (E) dated 25.10.2023.

 

Monitoring availability of drugs through weekly surveys: The availability of key medicines at the retail level is being monitored through regular surveys conducted by Price Monitoring Resource Units (PMRUs) in their respective States/ UTs at chemist shops at various locations across the country. During the Calendar year up to 20.12.2023, 50 surveys are conducted by the PMRUs.

Monitoring & Enforcement Activities The Government is effectively monitoring the prices of scheduled as well as non-scheduled medicines under DPCO, 2013 and takes action against companies found overcharging the consumers based on the references received from the State Drugs Controllers; individuals; samples purchased from the open market; reports from market based data; and complaints reported through the grievance redressal websites, ‘Pharma Jan Samadhan’ and ‘Centralized Public Grievance Redress and Monitoring System (CPGRAMS)’. During the year 2023, 1310 samples were collected and 603 cases were found prima facie price violation.

E-initiatives: NPPA has undertaken the following e-initiatives for better disposal of grievances of general public:

 

A.      Pharma Sahi Daam and Pharma Jan Samadhan APP

The Pharma Sahi Daam App 2.0 available on Android as well as iOS platform has features like searching of prices for medicines (brand wise or formulation wise), search latest ceiling prices of scheduled drugs, etc. Users can compare the prices of different brands of same formulation; and share price detail on messages etc. The app or search medicine facility tool facilitates consumers to verify whether medicines are being sold within the approved price range and also to detect any case of overpricing by pharmaceutical company/chemist.

Users can also register a complaint or view the status of the complaint, which was raised earlier (OTP authentication). If there is any ceiling price violation, the buyer will be able to lodge a complaint against company/ chemist through Pharma Jan Samadhan/ Pharma Sahi Daam (http://www.nppaindia .nic.in/redressal.html).

There were over One Lakh downloads of the App with rating of 3+.

B.      Integrated Pharmaceutical Database Management System (IPDMS)

Integrated Pharmaceutical Database Management System is an integrated system which was launched by NPPA in 2015. However, an upgraded, responsive cloud-based version, IPDMS 2.0 was launched on 29^th August, 2022. It is a system for online information collection, processing and communication portal to monitor and regulate the prices of medicines and medical devices, to ensure availability and affordability of drugs and medical devices in the country. During this Calendar year, as on 20.12.2023, 298 number of companies and 52530 products registered in IPDMS.

Consumer Awareness, Publicity and Price Monitoring (CAPPM) Scheme

CAPPM Scheme has two components, viz. (i) Assistance to set-up Price Monitoring and Resource Units (PMRUs), and (ii) Advertisement and Publicity for CAPPM. PMRUs are societies registered under the Societies Registration Act having its own Memorandum of Association/ Bye laws and they function under the direct supervision of the concerned State Drug Controllers for increasing outreach of NPPA. During the year 2023 (till 20.12.2023), PMRUs have been set-up in 5 States/UTs namely, Meghalaya, Arunachal Pradesh, Chandigarh, Assam and Dadra Nagar Haveli & Daman Diu. With these, the PMRUs are present in thirty States/UTs.

 

IEC Activities under CAPPM:

a.       NPPA has organized Twelve (12) online webinars and four (4) awareness campaigns. The main aim of these webinars/ campaigns was on awareness and guidance regarding monitoring of price movement of scheduled/ non-scheduled formulations; weekly survey; collection/ purchase of test samples of medicines; reporting of likely violation cases through IPDMS; guidance on incurring of Expenditure through PFMS; and maintenance of records/ supporting documents and submission of Monthly report including Static and dynamic reports.

b.       India MedTech Expo 2023 event on Medical Devices sector from 17th - 19th August 2023 at Helipad Exhibition Centre, Gandhinagar, Gujarat: Department of Pharmaceuticals, Government of India organized a large-scale event ‘India MedTech Expo 2023’ event on Medical Devices sector from 17^th – 19^th August 2023 at Helipad Exhibition Centre, Gandhinagar, Gujarat with the focus to showcase India’s journey and opportunities in the sector. The main objective of the event was to bring together industry, academia, research institutions, investors, state governments, MedTech parks and the Government bureaucrats for taking the Pharma sector on a forward growth trajectory. The inaugural event held on 17^th August 2023 was graced by Hon’ble Union Minister of Health & Family Welfare and Chemicals & Fertilizers, Dr. Mansukh Mandaviya along with Chief Minister of Gujarat Shri Bhupendrabhai Patel. Dr. V.K. Paul, Member, NITI Aayog; Ms. S. Aparna, Secretary Pharma; Shri K.K. Pant, Chairman NPPA, along with other dignitaries were also present. The dignitaries also unveiled the Coffee Table Book titled:

 

Coffee Table Book: The Coffee Table Book showcases the inspiring story of India becoming “Pharmacy of the world”. It throws light on the visionaries from the past to future whose collective efforts have transformed the generic drug industry into a vital cornerstone of modern healthcare. The book serves as a testament to the tireless efforts and unwavering dedication of countless individuals who have contributed to the development, accessibility, and success of the sector.

 

c.       Awareness Campaign by NPPA at India Medtech Expo 2023: A three (3) day Awareness Campaign at ‘India Medtech Expo 2023’ in Gandhi Nagar, Gujarat was conducted by NPPA along with the Officials of PMRU Gujarat from 17.08.2023 to 19.08.2023 by displaying creatives, running TVCs on LED screen, distributing brochures and providing information through interaction/ discussion with people. During the campaign awareness was made to the visitors including the Doctors, Govt. Officials, Pharmaceutical/ Medical Device manufacturer/ Marketers, Pharma Students, Start-ups and common people about Pharmaceutical Pricing, Functions of NPPA, Pharma Sahi Daam Mobile App and IPDMS 2.0. More than 250 people were covered during the campaign.

d.     Webinar on Management of expiry/ near expiry medicines: In the Run-up of India @ 75, ‘Azadi ka Amrit Mahotsava’, NPPA organized a webinar with PMRUs on ‘How to handle medicines nearing expiry date or already expired’ on 14th August 2023. The main aim of webinar was to provide guidance and sharing of knowledge with PMRUs to ensure the safe and responsible disposal of expiry/ near expiry medicines. In the webinar, Dr. H.S. Rehan, Director, Professor and Head, Department of Pharmacology, Lady Hardinge Medical College and Associated Hospital, apprised about:

• Factors contributing to high prevalence of expired drugs

• Types of Pharmaceutical waste

• Hazards of unused/ expire medicines

• Challenges in handling expiry/ near expiry medicines

• Strategies to reduce wastage of medicines

• Methods for safe disposal of medicines

 

e.       During this period of Special Campaign 3.0, NPPA adopted following two best practices:

 

i.        To ensure the safe and proper disposal of leftover / expiry/ near expiry medicines and to protect our environment, "Guidelines on Storage and Disposal of Drugs" was framed by NPPA in consultation with Lady Hardinge Medical College (LHMC)/Hospital and circulated to SDCs and PMRUs for use.. These guidelines will help the PMRUs to ensure the safe and responsible disposal of expiry/ near expiry medicines and to protect our environment.

ii.      With the objective of ensuring proper disposal of expired/unused medicines, National Pharmaceutical Pricing Authority (NPPA) in association LHMC / Hospital, Delhi and Mediflo undertook an initiative to keep a box in the YMCA, Cultural Centre Building at 1, Jaisingh Road, New Delhi- 110001 for collection of expired/unused medicines and their subsequent proper disposal.

 

f.       State Level Events/ Seminars organised by PMRUs: In the run up of India @75 ‘Azadi ka Amrit Mahotsava’, till 20.11.2023, Sixty-Four (64) State level events have been organized by PMRUs in their respective States/ UTs viz. Tripura, Jammu & Kashmir, Uttar Pradesh, Madhya Pradesh, Andhra Pradesh, Kerala, Mizoram, Punjab, Ladakh, Karnataka, Jharkhand, Nagaland, Haryana and Goa on various topics. These events were aimed for making awareness to people about Fixation of Ceiling Prices under NLEM 2022 and its’ significance in Healthcare, Drug Price Regulations under the provisions of DPCO, 2013, Role of NPPA in making the Drugs affordable and available for all, Functions of PMRUs, Pharma Sahi Daam Mobile App and IPDMS 2.0.

 

e-Newsletter of NPPA: Aushadh Sandesh

During the year, five issues of e-Newsletter were released. It contained information on the latest developments in the pharmaceutical sector in India as well as globally including regulatory activities of NPPA. In addition, an article by a pharma expert is also been included in these issues and following expert articles were carried in these five issues:

 

Month	Topic of Article
February, 2023	Tracking and Availability of drugs
April, 2023	Health technology assessment in India: implications for value-based pricing for drugs and devices
June, 2023	Biosimilars – the emerging wave for the Indian Pharma Sector
August, 2023	MSME and innovation
October, 2023	Changes in Disease Profile – Patient awareness and Action

 

Workshop on Review of working of DPCO, 2013 and NPPP, 2012

NPPA in coordination with DoP organized an interactive workshop under the chairmanship of Dr V.K. Paul, Member(Health), NITI Aayog on 16.05.2023 with the representatives of Pharmaceutical and Medical Device Associations on “Review of working of DPCO, 2013 and NPPP, 2012”. In the workshop, point related to Pharma, Medical Device and NPPP 2012 were discussed with the representatives of Pharmaceutical and Medical Device Associations. About 100 industry stakeholders participated in this workshop.

 

Medical Device:

The medical devices sector is an essential and integral constituent of the healthcare sector. The current market size of the medical devices sector in India is estimated to be 1.5%. The growth of medical device sector in India is primarily driven by growing and ageing population, increased per capita and disposable income, demand for healthcare infrastructure, rise in preventive testing and spread of healthcare services and insurance programs. The contribution of India’s medical devices sector to health become more evident during COVID-19 pandemic where role of medical devices and diagnostic kits, such as Ventilators, IR Thermometers, PPE Kits & N-95 masks, Rapid Antigen Test Kits, and RT-PCR kits etc. were of critical significance. Taking cognizance of the importance of the sector, few additional note-worthy interventions for the Medical Devices Sector, in addition to PLI and Medical Device parks, were also taken in 2023 which are:

 

1. Export Promotion Council for Medical Devices - Medical Device Industry Associations wanted to have a separate export promotion council for medical devices. Export Promotion Council for Medical Devices was established on 22nd May 2023 with headquarters in YEIDA, Greater Noida, Uttar Pradesh, under the aegis of D/o Pharmaceuticals. The primary objective of EPC-MD is to promote and facilitate exports of medical devices and related products from India.
2. India MedTech Expo (IMTE) 2023: India MedTech Expo (IMTE) 2023, 1^st edition was organized by the Department of Pharmaceuticals, GoI, from 17th-19^th August 2023 at Helipad Exhibition Center, Gandhinagar. It brought all stakeholders on one platform, creating opportunities to network and explore collaborations for sector’s growth in India. In the Event, more than 4000 Buyer-Seller meetings were organized and more than 10000+ visitors visited INDIA MEDTECH EXPO 2023
3. National Medical Device Policy, 2023

The Union Cabinet approved the National Medical Device Policy, 2023 on 26.04.2023. Policy aims to facilitate medical devices sector and guide it to achieve its missions through a set of strategies that will be covering six broad areas of interventions. The National Medical Devices Policy, 2023 mentions six (6) strategies for the promotion of the medical device industry: -

• Regulatory Streamlining
• Enabling Infrastructure
• Facilitating R&D and Innovation
• Attracting investments in the Sector
• Human Resources Development
• Brand Positioning and Awareness Creation

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