Year End Review of Department of Pharmaceuticals-2022

· 8916 Pradhan Mantri Bhartiya Janaushadhi Kendras opened across the country and target to increase to 10500 by March 2025

· Pharmaceuticals & Medical Devices Bureau of India made sales of Rs 758 crore this year

· Department of Pharmaceuticals gave special emphasis on promoting domestic manufacturing of medical equipment and strengthening the pharmaceutical industry

Ø Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP)

Ø FDI performance in pharmaceutical sector

Ø Pricing of drugs

Ø Strengthening of Pharmaceutical Industry (SPI)

Ø PLI for promotion of domestic manufacturing of critical Key Starting Materials (KSMs)/ Drug Intermediates (DIs)/ Active Pharmaceutical Ingredients (APIs)

Ø PLI Scheme for promoting Domestic Manufacturing of Medical Devices

Ø PLI Scheme for Pharmaceuticals

Ø Medical Device

In the year 2022, various programs and initiatives were implemented in the Department of Pharmaceuticals. Major achievements of the Department this year include schemes like 'Pradhan Mantri Bhartiya Janaushadhi Pariyojana' 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.

Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP):

Under Pradhan Mantri Bhartiya Janaushadhi Pariyojana scheme, dedicated outlets known as Pradhan Mantri Bhartiya Janaushadhi Kendras (PMBJK) are opened all over the country to provide generic medicines at affordable prices to the masses. Till 30^th November 2022, 8916 PMBJKs have been opened across the country. Target is to increase these kendras to 10500 by March 2025. Prices of the Jan Aushadhi medicines are generally 50%-90% less than that of branded medicines’ which are available in the open market. Medicines are procured from World Health Organization – Good Manufacturing Practices (WHO-GMP) certified suppliers only for ensuring the quality of the products.

The Product basket of PMBJP comprises 1759 drugs and 280 surgical. The target is to enhance the product basket to include 2000 medicines and 300 surgical products by March 2025 so that all essential medicines covering therapeutic groups, like - Anti Diabetics, Cardiovascular Drugs, Anti-Cancer, Analgesics & Antipyretics, Anti Allergic, Gastro Intestinal Agents, Vitamins, Minerals & Food supplements, Tropical Medicines, etc. are provided.

To ensure easy availability of the menstrual health services to all women across the country, “Janaushadhi Suvidha Oxy-Biodegradable Sanitary Napkin” are available for sale in all PMBJP Kendras across the country at ₹1.00 per sanitary pad. Till November, 2022, more than 31.00 Crore pads have been sold through these kendras.

In the financial year i.e. 2021-22, Pharmaceuticals & Medical Devices Bureau of India (PMBI) had made sales of Rs. 893.56 Crore which led to savings of approximately Rs. 5300 Cr. to the citizens. In the current financial year 2022-23 till 30^th November 2022, PMBI has made sales of Rs. 758 Crore which has led to savings of approximately Rs. 4500 Cr. to the citizens. Thus, in all, approximately Rs. 18,000 Crore have been saved under this Pariyojana in last 8 years.

IT-enabled End to End Supply Chain system has been implemented and one central warehouse at Gurugram and three regional warehouses at Chennai, Guwahati & Surat have been established. Further, it has been planned to open two more warehouses in Western and Central India.

FDI performance in pharmaceutical sector:

FDI inflows in pharmaceutical sector (in both pharmaceuticals and medical devices) was Rs 12,097 crore in the financial year 2021-22. During current financial year of 2022-23 from April 2022 to September 2022, FDI inflows has been Rs 8,081 crore. Further, the Department of Pharmaceuticals has approved 21 FDI proposals worth Rs. 4,681 crore for brownfield projects during 1^st January 2022 to 30^th November 2022.

Pricing of drugs:

Department of Pharmaceuticals (DoP) notified the amended Schedule-I of Drugs Prices Control Order (DPCO) 2013 on 11^th November 2022 based on National List of Essential Medicines 2022 Notified by Ministry of Health and Family Welfare on 13^th September 2022. Based on the same, National Pharmaceutical Pricing Authority (NPPA), an attached office under DoP is under process of revising the Ceiling Prices of the drugs coming under the Schedule-I as per extant provisions of DPCO, 2013.

On the occasion of 25^th Foundation day NPPA on 29^th August 2022, an updated version of Integrated Pharmaceutical Database Management System 2.0 (IPDMS) was launched which is an important step towards bringing in enhanced technology to facilitate the interface between Government and the stakeholders. On the same occasion, updated version of Pharma Sahi Dam Mobil App 2.0 was also launched, which empowers the consumers.

Strengthening of Pharmaceutical Industry (SPI):

The Scheme would be operational over a period of five years from FY 21-22 to 25-26 and has an outlay of Rs.500 cr. The Scheme has 3 components / sub-schemes:

· Assistance to Pharmaceutical Industry for Common Facilities (APICF)

· Pharmaceutical Technology Upgradation Assistance Scheme (PTUAS)

· Pharmaceutical & Medical Devices Promotion and Development Scheme (PMPDS)

Under sub-scheme Assistance to Pharmaceutical Industry for Common Facilities (APICF), 20 project proposals have been received of which 17 were found eligible under the scheme. Of these 17 project proposals, 7 have been shortlisted and requested to submit the DRP by 15^th December, 2022 for further examination and finalization for approval of projects.

Under Sub-Scheme Pharmaceutical Technology Upgradation Assistance Scheme (PTUAS) more than 60 applications have been registered.

PLI for promotion of domestic manufacturing of critical Key Starting Materials (KSMs)/ Drug Intermediates (DIs)/ Active Pharmaceutical Ingredients (APIs):

The Scheme was approved with the objective of attaining self-reliance and reducing import dependence in critical KSMs/DIs/APIs. The scheme will boost domestic manufacturing of identified KSMs, DIs and APIs by attracting large investments in the sector and thereby reduce India’s import dependence in critical APIs.

The tenure of the sub-scheme is from financial year 2020-21 to 2029-30, with the total financial outlay of Rs. 6,940 crore. The Financial incentive under the sub-scheme is provided on sales of 41 identified products categorized into four Target Segments. Total 249 applications were received in four Rounds. 51 applicants have been approved with committed investment of Rs 4,138.41 cr. against which investment of Rs. 1707 cr. has already been incurred. These 51 projects are expected to generate an employment of around 10,598 persons. The work on these projects have already generated employment of 1,907 persons up to September, 2022. Based on Quarterly Review Report (QRR) of September, 2022, 21 project has been commissioned with actual investment of Rs. 890.82 cr. as against total committed investment of Rs. 843.79 cr.

PLI Scheme for promoting Domestic Manufacturing of Medical Devices:

The Scheme envisages boosting domestic manufacturing and attracting large investments in the Medical Devices Sector. The tenure of the scheme is from FY 2020-21 to FY 2027-28 with total financial outlay of Rs. 3,420 crore. The financial incentive is to be given to selected companies at the rate of 5% on incremental sales of medical devices manufactured in India and covered under the Target segments of the scheme, for a period of five (5) years.

The identified products under this Scheme have been categorized into four Target Segments which is “Cancer care/Radiotherapy medical devices, Radiology & Imaging medical devices (both ionizing & non-ionizing radiation products) and Nuclear Imaging devices, Anaesthetics & Cardio-Respiratory medical devices including Catheters of Cardio Respiratory Category & Renal Care medical devices and All Implants including implantable electronic devices”.

Total 42 applications were received in two round of application window. Out of 42 applications, 21 applicants have been approved with committed investment of Rs 1,058.97 cr and expected employment generation of around 6,411pesons. 13 projects have already been commissioned for 31 products as on September 2022. The actual employment generated up to September 2022 is 2,892 persons.

PLI Scheme for Pharmaceuticals: -

The objective of this scheme is to enhance India’s manufacturing capabilities by increasing investment and production in the sector and contributing to product diversification towards high value goods in the pharmaceutical sector.

The scheme covers pharmaceutical goods under following three categories-

Category 1: Biopharmaceuticals; Complex generic drugs; Patented drugs or drugs nearing patent expiry; Cell based or gene therapy drugs; Orphan drugs; Special empty capsules like HPMC, Pullulan, enteric etc.; Complex excipients; Phyto-pharmaceuticals; Other drugs as approved.

Category 2: Active Pharmaceutical Ingredients / Key Starting Materials / Drug Intermediates (except for the 41 eligible products already covered under the “PLI Scheme for promotion of domestic manufacturing of critical KSMs / DIs / APIs” at sl.no.(i) above).

Category 3 (Drugs not covered under Category 1 and Category 2): Repurposed drugs; Auto immune drugs, anti-cancer drugs, anti-diabetic drugs, anti-infective drugs, cardiovascular drugs, psychotropic drugs and anti-retroviral drugs; In vitro diagnostic devices; Other drugs as approved; Other drugs not manufactured in India.

The tenure of the Scheme is from Financial Year 2020-21 to Financial Year 2028-29. The scheme provides for incentives on incremental sales to selected participants under these categories at varying rate over the years ranging from 10% to 3%.

The scheme is expected to bring in investment of more than 17,000 crore in the pharmaceutical sector, promote the production of high-value products in the country and increase the value addition in exports. The actual investment of Rs 15,164 cr. have already been made by these 55 applicants.

The support under PLI schemes is expected to promote the production of high-value products in the country as well as generate employment for both skilled and unskilled personnel, estimated at 20,000 direct and 80,000 indirect jobs. The actual employment generated up to September 2022 is 22,560 persons.

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 USD 11 Bn and its share in the global medical device market is estimated to be 1.5%.

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 2022 which are:

i. Reconstitution of National Medical Devices Promotion Council - On 05.08.2022, the Department reconstituted the National Medical Devices Promotion Council as an inter-departmental council to interact frequently with the medical devices industry to take up matters for resolution, which are regulatory in nature and are spread over different departments. This institutional set-up is expected to resolve the issue of the medical devices sector, which is multi-disciplinary in nature.

ii. Export Promotion Council for Medical Devices - Department of Commerce vide O.M. dated 21^st September, 2022 has approved establishment of a separate Export Promotion Council (EPC) for Medical Devices at YEIDA, Uttar Pradesh. The Department has notified the OSD for carrying out further action. The EPC-MD will give the boost to the Medical Devices Sector.