Lok Sabha Question No. 392 (UNSTARRED), answered on 2020-09-15
Subject: Role of NPPA for Drug Availability
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Vinod Kumar Sonkar, Sangeeta Kumari Singh Deo, Raja Amareshwara Naik, Sukanta Majumdar, Jayanta Kumar Roy

## GOVERNMENT OF INDIA MINISTRY OF CHEMICALS & FERTILIZERS DEPARTMENT OF PHARMACEUTICALS

LOK SABHA UNSTARRED QUESTION NO. 392 TO BE ANSWERED ON 15 th  September, 2020

## Role of NPPA for Drug Availability

## 392.   SHRI IVINOD KUMAR SONKAR:

SHRIMATI SANGEETA KUMARI SINGH DEO:

DR. JAYANTA KUMAR ROY:

SHRI RAJA AMARESHWARA NAIK:

DR. SUKANTA MAJUMDAR:

Will the Minister of CHEMICALS AND FERTILIZERS be pleased to state:

- (a) whether the National Pharmaceutical Pricing Authority (NPPA) has played a crucial role in ensuring the availability of essential drugs at reasonable prices during the COVID 19 pandemic;
- (b) if so, the details thereof, State-wise including West Bengal;
- (c) whether the NPPA has set up a Control Room to prevent any shortage of medicines during COVID-19 pandemic and resolve public grievances;
- (d) if so, the details thereof;
- (e) whether the NPPA has supplied critical medicines from India during the pandemic to over 120 countries and if so, the details thereof; and
- (f) the details of other steps being taken by the Chemical and Fertilizer Ministry during the COVID 19 pandemic?

## ANSWER

## MINISTER IN THE MINISTRY OF CHEMICALS & FERTILIZERS

(SHRI D. V. SADANANDA GOWDA)

(a) & (b):     Yes Sir.     The National Pharmaceutical Pricing Authority (NPPA) played a crucial role in ensuring the availability of essential drugs at reasonable prices during the COVID-19  pandemic.  The  situation  arising  due  to  COVID-19  has  been  closely monitored by the NPPA. Timely and effective steps were taken to ensure no shortage of drugs during the lockdown  period throughout the country. To ensure  seamless availability of drugs, the NPPA set up a 'Control Room' with Helpline No. 1800111255 and issues like non-availability of medicines, masks, gloves, hand sanitizers etc., and price  violation  of  medicines,  masks,  gloves,  hand  sanitizers,  etc.,  were  resolved promptly. Also, a COVID-19 dashboard on the NPPA's website (www.nppaindia.nic.in) having latest office orders, circulars, helpline no., Email for sending grievances etc., was created for convenience of public and other stakeholders.

An  Inter-ministerial  Empowered  Committee  was  constituted  vide  order  dated 26.03.2020 to make recommendations for export of drugs/items requested by foreign

Governments.  This  committee  also  monitors  the  availability  and  supply  of  COVID-19 treatment drugs. The NPPA worked as a Secretariat to this Inter-ministerial empowered committee.

The NPPA has ensured the availability of drugs by coordinating with State Health Authorities  like  SDCs  and  Central  Govt.  Authorities  like  the Central  Drugs  Standard Control Organisation (CDSCO), Director General of Health Services (DGHS), Department  for  Promotion  of  Industry  and  Internal  Trade (DPIIT) etc.  The NPPA  collected  the  critical  information  from  drug  manufacturers  used  in  decision making to ensure drug availability.

The NPPA has taken steps to ensure the availability of Heparin used in COVID treatment.  Further,  on  intervention  in  the  issue  of  price-parity  of  N-95  Masks  by  the NPPA,  major  manufacturers/importers  of  N-95  Masks  have  reduced  their  prices significantly up to 67%.

The  NPPA  also  coordinated  issues  related  to  production  of  raw  material, medicines, medical devices, packaging material, etc. by manufacturers and movement of raw material, packing material, finished goods and manpower etc. to availability of life saving essential drugs during the lockdown.

The  NPPA  has  taken  various  steps  to  ensure  the  availability  of life  saving essential  drugs  like  Hydroxychloroquine,  Paracetamol,  Vaccines,  Anti-Tuberculosis drugs, Anti-diabetic drugs, cardiac drugs, imported Anti-epileptic drugs and COVID-19 drugs like FDC  Lopinovir & Ritonavir, Remidesivir, Favipiravir, Zinc Sulphate, Mythyleprednisolone, Enoxparin, Dexamethasone etc.

Further, on  the  intervention  of  the  NPPA  and  the  Drugs  Controller  General  of India , DCG(I), manufacturers of Remdesivir have created a Helpline to make available the  remdesivir.  However,  both  these  drugs  are  not  part  of  Covid-19  Protocol  and continue as under investigational therapy Drugs. The details of various steps taken by the NPPA are at Annexure 1.

The state-wise details of steps taken is not available, however in respect of West Bengal, the NPPA received 34 number of calls on its control room which were resolved promptly.

(c) & (d):   The NPPA has set up a Control Room to prevent any shortage of medicines during COVID-19 pandemic and resolve public grievances. The details of the Control Room are at Annexure 2.

- (e): Based  on  information received from the Directorate General  of Foreign Trade (DGFT) till  09.06.2020  (Till  Hydroxychloroquine  and  Paracetamol  were  under export  restriction),  exemptions  were  granted  to  export  Hydroxychloroquine  to  114 Countries and to export Paracetamol to 24 countries. Details are as following:-

|   S.No. | Drug               | API                                                                                                        |
|---------|--------------------|------------------------------------------------------------------------------------------------------------|
|       1 | Hydroxychloroquine | 44,783.34 Kgs (44.79 MT), 39,72,10,290 Tablets                                                             |
|       2 | Paracetamol        | 269.9 MT, 9,63,43,534(96.34 Million) Tablets, 4 Lakh Units (Suspension IP), 7,69,000 Bottles (100 ml each) |

Details received from DGFT are at Annexure 3.

- (f):       The details of other steps taken by the Department of Pharmaceuticals/Ministry of Chemicals and Fertilizers during the COVID-19 pandemic are at Annexure 4.

## Annexure 1

## MEASURES TAKEN FOR ENSURING AVAILABILTY OF DRUGS

1.         The NPPA vide D.O. letter dated 20 th Feb, 2020 requested all Chief Secretaries of States/UTs to closely monitor the production and availability ofActive Pharmaceutical Ingredients (APIs) and their formulations, and to take necessary  action  under  the  provisions  of  the  Drugs  (Prices  Control)  Order,  2013 (DPCO, 2013) to ensure availability of life saving essential drugs to the consumers at all times.
2.         In order to address the issues related to availability and pricing of critical Medical Devices  such  as  Masks,  Sanitizers  and  Gloves  to  deal  effectively  with   COVID-19 situation, the NPPA,vide letter dated 13 th March 2020 , requested MoHFW to prepone the effective date of consideration of Medical Devices as Drugs.
3.         The NPPA, vide order dated 13 th March, in exercise of powers under clause (l) of sub section (2) of section 10 of the Disaster Management Act directed all States/UTs and concerned State Authorities to take necessary steps to ensure sufficient availability of  surgical  and  protective  masks,  hand  sanitizers  and  gloves  at  prices  not  exceeding MRP  printed  on  pack  sizes.  Ministry  of  Consumer  Affairs  had  issued  order  dated 13 th March 2020 to regulate the production, quality, distribution, logistics of masks and hand sanitizers.
4.          In  an effort of continuous monitoring, a letter dated 18 th March, 2020 was also issued  to  all  State  Drug  Controllers  (SDCs)  directing  them  to  take  immediate  action through field officers to restrain acts of hoarding of surgical and protective masks, hand sanitizers  and  gloves  and  profiteering  by  manufacturers,  distributors,  stockists  and retailers of these items as well as to ensure availability and distribution of these items at prices not exceeding MRP.
5.          In  its  effort  to  maintain  seamless  availability  of  critical  drugs  and  Medical Devices related to COVID-19, NPPA vide letter dated 19 th March, requested Secretary (Textile)  to  put  temporary  export  restrictions  on  critical  inputs  (PP  MELTBLOWN  Non Woven  Fabric,  the  Nosewire  and  Loop  Elastic  non  latex)  for  Masks.  Further,  at  the intervention  by  NPPA,  DCGI  vide  Order  dated  19 th March  directed  all  Port  Offices  of CDSCO  to  take  proactive  measures  for  clearance  of  imported  stock  of  gloves  in coordination with Customs in expedited manner in public interest.
6.          The  issue  regarding  availability  of  N-95  Masks  and  PPE  kits  is entrusted  to Empowered Group 3 and the issues of 2 ply/3 ply Masks and Hand Sanitizers is being monitored by Ministry of Consumer Affairs and Department of Food respectively. The NPPA  undertook  database  creation  in  respect  of  N95  Masks,  PPE  kits,  2  ply/3  ply Masks  and  Hand  Sanitizers   and  shared  it  with  concerned  Authorities  for  effective monitoring.
7.         The NPPA made efforts to collect information regarding Domestic Manufacturers of  Masks,  Gloves,  Hand  Sanitizers,  PPE  Kits  and  Ventilators  in  the  Country.  In  this

regard, various meetings were held at NPPA as well as through Video conferencing with the stakeholders including industry associations. The compiled information was placed on  NPPA's  website  &  also  disseminated  to  MoHFW  and  all  States/UTs  to  assist  in procurement of these devices required for treatment of COVID-19.

## MEASURES TAKEN FOR ENSURING AFFORDABILITY OF N-95 MASKS

1.         In order to ensure availability of N-95 mask at affordable prices in the Country, NPPA vide O.M dated 21.05.2020, directed Manufacturers/ Importers/Suppliers of N95 Mask  to  maintain  parity  in  prices  for  non-government  procurements  and  to  make available  the  same  at  reasonable  prices  and  any  violation  of  the  same  would  invite action under Essential Commodities Act, 1955.
2.          After  issuing  such  an  Advisory,  major  manufacturers/importers  of  N-95  Masks have  reduced  their  prices  significantly  up  to  67%.  Further,  a  Press  Release  in  this regard  was  released  on  25.05.2020  for  dissemination  of  information  to  the  general public.

## MEASURES FOR LOGISTIC MANGEMENT FOR AVAILABILTY OF DRUGS

1.          NPPA associated with Empowered Group 5 headed by Secretary, Department of  Drinking  Water  and  Sanitation,  regarding  'Facilitating  supply  chain  &  Logistics Management for availability of necessary items such as Food & Medicines' to flag the logistics issues of Pharmaceutical Industry to ensure the seamless availability of drugs across the Country.
2.         In lockdown period the Pharmaceutical sector faced serious challenges relating to logistics of raw materials and manpower. In this regard, NPPA took many initiatives in management of logistic  disruption  faced  by  the  Pharmaceutical  Industry  which  led  to increased availability of Medicines and Medical Devices across the Country.
3.          The  NPPA  took  measures  for  availability  of  Drugs  for  COVID-19  and  other Essential Drugs including HCQ, Paracetamol, Vaccines, TB, Insulin and other cardiac drugs.  NPPA  is  also  dealing  with  issues  related  to  sub-optimal  production,  logistics, MIS, shortages and exports.
4.          The  shortage  of  imported  Anti-epileptic  drugs  (particularly Sabril  500)  was reported by MoHFW and some NGO groups. NPPA immediately took necessary action and the issue was addressed promptly. Similarly, the issue of availability of imported drug Acterma of COVID-19 treatment, was facilitated through discussion with Cipla, the importer.
5.         NPPA vide D.O. letter No. 37001/2020/Div.-III/NPPA/Part dated 25 th April, 2020 to  Administrator,  Daman  &  Diu  and  Chief  Secretary  Maharashtra,   requested  to  take immediate necessary action in respect of resolution of bottlenecks to mitigate the risk of shortage of Anti-TB medicines in the country .
6.          Further,  based  on  communication  dated  21 st April,  2020  from  Joint  Secretary (RCH) referring to the letter dated 14 th April 2020 of the Secretary (Health), requesting to  address  transportation  issues  due  to  nationwide  lockdown  to  ensure  seamless availability of vaccines required to successfully conduct Universal Immunization Programme (UIP), NPPA, vide letter dated 21 st April, 2020, requested Ministry of Civil Aviation,  GoI  to  take  immediate  steps  regarding   airlifting  of  necessary  supplies  of vaccines, at the earliest, as it is critical for the smooth operation of UIP.
7.          The  grievances  received  at micro  and macro level from individuals as well as from Associations/ Industry and Institutions/ Departments were taken care of to address all  issues.  During  the  lockdown,  complaints  were  received  regarding  non  access  to critical medicines. These were got home delivered through coordination with SDCs.
8.          On  26 th March,  2020,  NPPA requested all  States/UTs  to  ensure  unobstructed movement of Raw material, packing material, finished products and manpower related to manufacturing and distribution of drugs and medical devices.

## CREATION OF DASHBOARD FOR COVID-19

NPPA created a COVID-19 dashboard on its website having latest Office orders, circulars, helpline no., Email for sending grievances etc. for convenience of public and other stakeholders. Link: http://www.nppaindia.nic.in/en/whats-new-about-coronavirus/.

## CREATION OF COVID AND COVID PLUS DRUGS DATABASE

NPPA  in  coordination  with  DCGI  developed  a  comprehensive  database  for COVID  &  COVID  plus  (55+97)  drugs  as  a  measure  of  preventive  preparedness  for fighting COVID-19. This will be immensely useful in current scenario as well as future needs of the organization. DCGI has been directed to create a state-wise mechanism to obtain timely alerts (ring the bell) in case of shortages to take remedial action.

## MEASURES TAKEN TO ENSURE AVAIALBILITY OF MEDICAL OXYGEN

NPPA  also  coordinated  the  issue  of  availability  of  Medical  Oxygen.  The Empowered Group of Secretaries Group-3 (EGoS-3) considered the representation of All  India  Industrial  Gas  Manufacturers  Association  (AIIGMA)  regarding  cost  impact  of production of medical oxygen by the major manufacturers on 27th May, 2020. The Tariff Commission was asked to examine the claim.

The NPPA coordinated the supply of data for medical oxygen from companies to Tariff  Commission and ensured that examination of claim is done timely. In its report, Tariff Commission has mentioned that the claim of AIIGMA relies mainly on venting of various gases on account of production of  oxygen and increase in electricity consumption cost.  However both grounds are prima facie not substantiated based on data provided by AIIGMA / manufactures and reject the price increase claim.

## MEASURES  TAKEN  TO  ENSURE  AVAILABILTY  OF  DRUGS  PLACED  UNDER EXPORT RESTRICTIONS

1.          Paracetamol  and  Hydroxychloroquine  along  with  other  drugs  were  put  under export prohibition to ensure drug security in the country. NPPA made all out efforts to collect  data  regarding  manufacturing  capacity,  domestic  requirement,  current  stock, procurement orders of APIs/KSMs/Intermediates in respect these drugs placed under export restriction.
2.         Based on detailed examination of the stock position, manufacturing capacity and domestic  requirement  of  Paracetamol,  DoP/NPPA  vide  letter  dated  15th  May,  2020 recommended to DGFT for lifting of ban on export of Paracetamol API with the condition for  major  manufacturers  to  maintain  supply  of  equivalent  quantity  in  the  domestic market.  The  NPPA  is  regularly  monitoring  the  details  regarding  manufacturing,  stock position and  supplies  of  Paracetamol  API  made  to  domestic  market  by major manufacturers.
3.         The  NPPA, vide dated 11.06.2020,recommended to DGFT for lifting of ban on export  of  Hydroxychloroquine  API  and  formulations  with  the  condition  for  major manufacturers to maintain sufficient availability in the domestic market .
4.          The  NPPA  is  regularly  monitoring  the  details  regarding  manufacturing,  stock position and supplies of Hydroxychloroquine made to various authorities/ agencies by major manufacturers .

## MONITORING THROGH SURVEY

The availability of key medicines is also monitored through chemist level surveys conducted by the CDSCO, AIOCD surveys and Pharmatrac reports.

## MEASURES TAKEN TO ENSURE AVAIALBILTY OF OTHER COVID-19 DRUGS

1.         As and when any drug (e.g. FDC Lopinovir& Ritonavir, Remidesivir, Favipiravir, Zinc  Sulphate,  Mythyleprednisolone,  Enoxparin,  Dexamethasone  etc)  comes  under consideration  for  treatment  protocol  of  COVID-19,  NPPA  pro-actively  initiated  task  of collection of information to assess availability situation in the Country.
2.          NPPA,  on  receiving  of  estimated  quantity  required  from  MoHFW,  vide  letter dated 03.07.2020 and 16.07.2020 directed Major manufactures of Mythyleprednisolone, Enoxparin,  Dexamethasone  to  ensure  sufficient  production  and  availability  of  these drugs across the country .

## MEASURES TAKEN TO COORDINATE WITH SDCs

NPPA  conducts  regular  meeting  through  VC  with  SDCs  and  Drug  Manufacturers  to monitor the availability of drugs and takes appropriate action. NPPA also coordinates with SDCs through a WhatsApp group created for this purpose.

## MEASURES TAKEN TO ENSURE AVAIALBILTY OF HEPARIN:

NPPA received representations from several manufacturers for upward revision of  ceiling  prices  of  Heparin  Injection  5000IU/  ml  which  has  been  considered  as  an essential COVID plus medicine by Ministry of Health & Family Welfare. To ensure the availability, NPPA increased the ceiling price of Heparin for a period of six month.

## MEASURES TAKEN TO STOP PRICE RISE OF DRUGS

1.         National Pharmaceutical Pricing Authority (NPPA) issued necessary instructions to  DCGI,  States/  UTs  to  ensure  adequate  supply  of  APIs  and  formulations  including surgical  and  protective  masks,  hand  sanitizers  and  gloves  at  affordable  prices  in  the market  and  to  prevent  black  marketing  and  hoarding  which  could  create  artificial shortages in the country.
2.          The  NPPA took cognizance of reports of black marketing of  Remedesvir and Toclizumab  and  directed  the  DCGI  to  issue  necessary  instruction  to  SDCs  to  take appropriate action in this respect.
3.          Several  requests  from  State  Governments,  NGOs  and  general  public  were received regarding fixation of prices for N-95 masks as the same were available in the market at exorbitant and differential prices. In order to ensure availability of N-95 mask at  affordable  prices  in  the  Country,  NPPA  vide  O.M  dated  21.05.2020,  directed manufacturers/ importers/suppliers of N-95 masks to maintain parity in prices for nongovernment procurements and to make available the same at reasonable prices and any  violation  of  the  same  would  invite  action  under  the  Essential  Commodities  Act, 1955.
4.          After  issuing  such  an  Advisory,  major  manufacturers/importers  of  N-95  Masks have  reduced  their  prices  significantly  up  to  67%.  Further,  a  Press  Release  in  this regard was released on 25.05.2020 for dissemination of information to general public.
5.         The NPPA also took cognizance of complaints of black marketing and hoarding of  N-95  Masks  and  directed  SDC  Maharashtra  to  take  necessary  action.  SDC conducted raid on the company doing black marketing and hoarding of N-95 Masks.

## NPPA's CONTROL ROOM AND HELPLINE

As a measure to deal with the emerging situation arising due to outbreak of COVID-19 pandemic,  including  to  ensure  seamless  availability  of  drugs  including  masks,  hand sanitizers and gloves, the NPPA set up a 'Control Room' with Helpline No. 1800111255 and  e-mail  IDmonitoring-nppa@gov.in on  20th  March  2020.   The  Control  Room  has attended 1867 calls and addressed all types of the complaints in coordination with the State Drug Control Departments, AIOCD, AIMED etc. till 31.08.2020.

The NPPA's Control Room team worked  on 24 x 7 basis, in 3 shifts, on virtual basis through remote locations and has made serious efforts, in coordination with O/o Chief Secretaries of States/UTs, SDCs,  District/ State Administration and  other State Authorities,  for  prompt  resolution  of  number  of  issues.  The  list  of   issues  resolved through the NPPA Control Room is given below:

|   Sl. no. | Issues                                                                                                                           |
|-----------|----------------------------------------------------------------------------------------------------------------------------------|
|         1 | Non-availability of medicines, masks, gloves, hand sanitizers, etc.                                                              |
|         2 | High price of medicines, masks, gloves, hand sanitizers, etc.                                                                    |
|         3 | Coordination in permission for production of raw material, medicines, medical devices, packaging material, etc. by manufacturers |
|         4 | Coordination in movement of raw material, packing material, finished goods and manpower.                                         |

## Annexure 2

## Annexure 4

## Details  of  other  steps  by  the  Department  of  Pharmaceuticals  in  Covid-19 pandemic related response.

Since the onset of  the  COVID-19 pandemic and through all subsequent lockdown periods, Department of Pharmaceuticals (DoP) has been working on mission mode to address the difficulties and challenges.  High import dependence for raw materials to produce critical drugs and supply chain disruption, limited domestic capacities to manufacture  health  care  equipments  and  diagnostic  kits,  and  the  restrictions  of lockdown themselves- threw different challenges for ensuring continued production of  essential  drugs  and  medical  devices  and  maintaining  their  supplies.  During lockdown  periods,  it  was  also  challenging  to  coordinate  and  cooperate  among different central government departments, state governments, industry associations and  logistic  companies  as  the  manufacturers  faced  various  problems  at  different levels  related  to  transportation  and  logistics  for  carrying  both  raw  materials  and finished products, shortage of labour etc.

The various challenges faced and the actions taken by DoP  and National Pharmaceutical  Pricing  Authority  (NPPA),  an  attached  office  of  the  Department, including National Institutes of Pharmaceutical Education & Research (NIPERs) and Bureau of Pharma PSUs of India (BPPI) are given as follows;-

## 1. Department of Pharmaceuticals:

## A.         Assessing  the  availability  and  ensuring  adequate  stock  of  essential items.

- (i)          India,  one  of  the  largest  manufacturers  of  drug  formulations/medicines  is heavily  dependent  on  China  for  import  of  critical  bulk  drugs.  India  imports  around 70% of total  imports  of  bulk  drugs  from  China.  The  outbreak  of  the  deadly  Novel Corona  Virus  (COVID-19)  in  China  in  December  2019  brought  out  the  risk  of disruption  of  supply  chain  which  could  jeopardize  the  Indian  pharma  sector  and could  have  adverse  impact  on  the  drug  security  in  India. DoP  was  aware  of  the situation  and had been constantly monitoring the availability of medicines to avoid any potential shortage in the country.
- (ii)         Immediately  after  the  first  case  of  the  COVID-19  which  was  reported  on 30.01.2020 in the country, DoP assessed the situation and took fast track actions as a  measure  of  public  health  preparedness.  The  Department  held  a  series  of meetings on  31st  January,  2nd,  3rd  and  6th  February  2020  with  all  the  relevant stakeholders to assess the domestic availability of (i) Drug Lopinavir+Ritonavir fixed drug combination which was included in the initial protocol of ICMR for treating the COVID-19  disease  (ii)  Active  Pharmaceutical  Ingredients  (API),  intermediates  and Key Starting Materials (KSM) for which India was critically dependent on China.
- (iii)        Further,  DoP  helped  Ministry  of  External  Affairs  and  Ministry  of  Health and Family Welfare to procure various supplies needed.

(iv)        Meetings  were  held  under  the  chairmanship of  Secretary,  Pharmaceuticals on  23.03.2020  and  24.03.2020  to  review  the  status  of  availability  of  ventilators, thermometers,  PCR machines, diagnostics  kits  and  related  logistics  issues  and  to explore manufacturing of ventilators by domestic automobile companies.

- (v)         DoP  conducted  series  of  meetings  through  Video  conferencing  with  the officers/  officials  of  Central  Government  Ministries/  Departments/  Organisations, DCGI/ State Drug Controllers/ Pharma and Medical Device Associations, Pharma/ Medical Device Manufacturers and Air Cargo Units for ensuring availability/ stock of medicines  and  medical  devices  (PPE  kit,  Gloves,  Masks,  Hand  Sanitizers,  Face Shield, other essential medicines and logistics issues).
- (vi)       An inter-ministerial Committee was constituted by DoP on 06.02.2020 under the  chairmanship  of  Dr.  Eswara  Reddy,  Joint  Drugs  Controller,  Central  Drugs Standard Control Organization (CDSCO) to address the issue of drug security in the country. The committee submitted its report on 27.02.2020. The Committee reviewed the  situation  regarding  impact  on  import  of  APIs  and  KSMs  due  to  outbreak  of Corona  virus  and  identified  four  core  issues  viz.  (1)  Disruption  of  manufacturing activity in China due to holidays (2) Logistics issues (3) Restriction on movement of personnel, and (4) Availability of raw materials for manufacturing of APIs/KSMs. The committee observed that there could be major impact on import of certain APIs and KSMs which were manufactured in Hubei province in China.

(vii)       Based  on  the  recommendations  of  the  Committee,  DoP  issued  necessary instructions  to  National  Pharmaceutical  Pricing  Authority  (NPPA),  Drugs  Controller General of India (DCGI) and State Governments to ensure adequate supply of APIs and formulations at affordable prices in the market and to prevent black-marketing, illegal hoarding, creating artificial shortages in the country and recommended DGFT to  restrict  exports  of  13  API  and  formulations  made  using  these  APIs.  (On 03.03.2020 DGFT notified restriction on exports of 13 APIs and their corresponding formulations as a measure against the implications of COVID-19 outbreak in China.)

## B.         Historical  decision  to  ensure  domestic  manufacturing  of  critical  bulk drugs and medical devices.

A  Technical  Committee  was  constituted  by  DoP  on  02.03.2020  under  the chairmanship of Dr. Eswara Reddy, Joint Drugs Controller, Central Drugs Standard Control Organization (CDSCO)  to  make  recommendations  for  the  revival of fermentation  industry,  new  technologies  for  manufacturing  of  APIs  including  its backward integration, costing of the projects and identification of strategic business models.  On  the  basis  of  the  recommendations  of  the  committee,  Department  had prepared the following four schemes - two for promoting domestic manufacturing of Bulk  Drugs,  and  two  for  promoting  domestic  manufacturing  of  Medical  Devices; which were approved by the Union Cabinet on 20.03.2020.

- (i) Promotion of Bulk Drug Parks : to provide grant-in-aid to 3 Bulk Drug Parks for  creation  of  Common  Infrastructure  Facilities  (CIF)  with  a  maximum  limit  of Rs.1000 Crore per park or 70% of the project cost of CIF, whichever is less. The total  size  of  the  Scheme  is  Rs.3000  Crore  and  tenure  of  the  Scheme  will  be  five years (2020-21 to 2024-25).
- (ii) Production  Linked  Incentive  (PLI)  scheme : Under  the  scheme,  financial incentive is given to eligible manufacturers of 53 KSMs/Drug Intermediates and APIs on  their  incremental  sales  over  the  base  year (FY  2019-20)  for  6  years.  For fermentation  based  eligible  products,  incentive  for  the  first  four  years  (2023-24  to 2026-27) would be 20%, for fifth year (2027-28) 15%, and sixth year (2028-29) 5%, on incremental sale of KSMs/ Drug Intermediates/ APIs. For chemically synthesized eligible  products  incentive would  be  10%  on  incremental  sales  of  KSMs/Drug Intermediates/  APIs  for  6  years  (2022-23  to  2027-28).  A  total  outlay  of  Rs.  6,940 Crore has been approved for the scheme.
- (iii) Scheme  for  Promotion  of  Medical  Device  Parks :  The  total  size  of  the Scheme  is  Rs.400  Crore  and  tenure  of  the  Scheme  will  be  five  years  (202021 to 2024-25). The scheme will provide grant-in-aid to 4 Medical Device Parks with a maximum limit of Rs. 100 Crore per park or 70% of the project cost of Common Infrastructure  Facilities,  whichever  is  less.  In  case  of  hilly  states  and  North  East Region, the grant-in-aid would be Rs. 100 Crore per park or 90% of the project cost of  Common  Infrastructure  Facilities,  whichever  is  less.   The  assistance  under  the proposed scheme will be admissible for creation of Common Infrastructure Facilities such  as  Component  Testing  Centre,  Electro-magnetic  interference  laboratory, Biomaterial  /  Biocompatibility  testing  centre,  Medical  grade  low  vacuum  moulding, Cabinet moulding, injection moulding centres, 3D designing and printing for medical grade  products,  Sterilization  and  Toxicity  testing  centre,  Radiation  testing  centre etc.  The scheme would be implemented through a State Implementing Agency (SIA) to be formed by the concerned state government.

(iv) Production Linked Incentive Scheme for Promoting Domestic Manufacturing  of  Medical  Devices :  The  Cabinet  has  also  approved Production Linked  Incentive  (PLI)  scheme  for  promoting  domestic  manufacturing  of  medical devices with a financial outlay of Rs. 3420 Crore. The medical devices manufacturing sector faces lack of a level playing field vis-à-vis  competing economies. The sector suffers from a disability of around 12% to 15% on account of various  factors.  The  recently  approved  PLI  Scheme  will  provide  financial  incentive with an objective to boost domestic manufacturing and attract large investments in the  Medical  Device  sector.  The  Scheme  shall  extend  an  incentive  of  5%  on incremental  sales  (over  base  year)  of  goods  manufactured  in  India  and  covered under  target  segments,  to  eligible  companies,  for  a  period  of  five  (5)  years.  The tenure of the Scheme will be from 2020-21 to 2026-27.

## C.        Support to Industry during lockdown

The  lockdown  across  the  country  in  the  wake  of  the  COVID-19  pandemic  had resulted  in  supply  disruptions  even  though  pharmaceutical  and  medical  device industry was exempted by the government from the lockdown as they were included under  essential  services.  The  major  challenge  was  with  respect  to  transportation, especially inter-state movement of medicines and medical products and movement of labourers. In addition, there were other challenges in terms of non-availability of ancillary services such as availability of packing materials, courier services etc.

## D.        Actions initiated in the Department to address Logistics related issues

(i)         Regular meetings were  held with State Drug Controllers, Drug and medical devices  manufacturer's  Associations  and  Chemists  and  Pharmacists  Associations. Issues brought to knowledge of the department were assessed and resolutions given on  real  time  basis.  Cases  brought  out  by  Industry  Associations  &  general  public continuously taken up with the States/UTs over phone calls and e-mails and were resolved.

(ii)         Various  WhatsApp  groups  were  formed  to  tackle  issues  arising  out  of lockdown  e.g. group  of associations of  pharmaceutical  and  medical  devices manufacturers, group of distributors of AIOCD, group of Drug Controller General of India  with  the  state  drug  controllers,  group  of  automobile  companies  interested  in manufacturing ventilators, group of glove manufacturers, group of masks manufacturers,  overall  IMC  group  on  exports  of  medicines,  group  of  officers  from railways  and  postal  services  etc.  Many  issues  were  brought  to  the  knowledge  of department  through  these  WhatsApp  groups  which  were  flagged  to  concerned states/ departments for resolution.

(iii) A Control Room (with Phone No. 011-23389840 and email: helpdeskpharma@gov.in) was set up on 28.03.2020 in Department of Pharmaceuticals  for  handling  transport  and  logistics  services  related  issues  of industry engaged in providing essential services following the lockdown across the country.  A  total  of  277  cases  were  handled  from  29.03.2020  to  20.05.2020.  The cases received were related to the following issues viz. transportation of goods/medicines/ medical equipment; cargo/custom related issues; regulatory issues; shortage of workers, issue of e-pass to employees/workers etc.; availability of essential medicines; Inter-state transport issues; medical equipment manufacturing  and  manufacturing  restricted  /barred  in  some  states;  permission  to function  printing  and  packaging  units  required  by  drug  manufacturers.  The  issues raised  were  effectively  resolved;  required  information  provided;  some  issues  were forwarded to concerned authorities for redressal.

(iv) DoP  requested Ministry of Home  Affairs (MHA)  to issue necessary instructions to State Authorities for effective resolution of issues faced in production, distribution and management of critical, lifesaving essential medicines and medical devices including non-operational courier services and ancillary suppliers of inputs including  packaging  materials,  excipients,  utility  consumables  and  spare  parts  not recognized as essential services in the wake of lockdown for COVID -19. MHA was further  requested  to  take  suitable  effective  measures  to  prevent  any  shortage  of medicines  and  medical  devices  in  future  and  DoP  made  certain  suggestions  for tackling the situation including ferrying back contractual labourers from their native places;  treating  commercial  driving  license  as  a  pass  during  the  lock  down; sensitizing  local  authorities  of  the  need  to  restore  production  of  medicines  and medical devices, restoration of courier services etc.

(v)        DoP was in constant touch with Key Ministries/Depts. including Civil Aviation, Posts, Air Force, Railways, Customs for effective resolution of transport and logistics services related issues in ensuring availability of medicines across the country.

(vi) DoP conducted various meeting through video conferencing with representatives of major pharma and medical device associations to discuss latest issues/ challenges faced by them following lockdown for COVID  -19; to obtain the status  updated  from  the  industry  regarding  their  working  and  to  take  suggestions from them on tackling the situation.

(vii)       DoP  had  requested  all  Chief  Secretaries  of  States/UTs  to  ensure  that  all district  authorities  and  field  agencies  were  informed  that  no  separate  passes were required for through traffic of trucks and goods carriers including empty trucks etc., so that there was no ambiguity at the ground level and movement of through traffic of trucks and goods carriers including empty trucks was allowed without hindrance.

(viii)      Further,  DoP  along  with  NPPA  and  CDSCO  were  regularly  monitoring  the working  status  of  pharmaceutical  and  medical  device  manufacturing  units  and assessed  the situation, pre COVID and post COVID.

## E.         Letters  written  to  Ministries/  Departments/  States  etc.  by  Secretary (Pharma)

(i)         Secretary (Pharma) wrote to all the Chief Secretaries of States and UTs on 23.03.2020 to direct the authorities concerned to make necessary arrangements for issuance of IDs/Entry Passes so as to facilitate movement of the workers engaged in these essential activities.

(ii)        Secretary (Pharma) on 02.04.2020 also wrote to Secretary, Ministry of Home Affairs  to  issue  necessary  instructions  to  State  authorities  in  order  to  ensure availability  of  life  saving  essential  medicines  during  this  critical  time.  Further, Secretary (Pharma) vide DO dated 03.04.2020 to Secretary, Ministry of Home Affairs requested  for  issuing  appropriate  instructions  for  urgent  intervention  of  the  State authorities in the issues related to the supplies of ancillary goods and operation of courier services.

(iii)       Secretary (Pharma)  also wrote on 09.04.2020 to Secretary, Ministry of Home Affairs  suggesting  measures  to  prevent  shortage  of  medicines  in  the  domestic market, which included allowing pharma and medical device industry to ferry back their  contractual  labourers  from  their  native  places,  allowing  drivers  in  possession with  driving  license  of  a  commercial  vehicle  to  move  with  or  without  their  vehicle, addressing the apprehensions of drivers regarding ill treatment by the police and to motivate/incentivize (Insurance etc.) them, sensitizing State and District Authorities to the need of bringing back the production of pharma and medical device industry to its pre lockdown level and need to make courier services fully functional for ensuring movement of medicines and medical devices.

(iv)        Secretary  (Pharma)  on  24.04.2020 wrote  to  Secretary,  Ministry  of  Home Affairs  for  issuing  instructions  to  State  authorities  to  take  effective  measures  for enabling pharma units to work in full capacity and raise the production to reach the pre-lockdown level and avoid future shortages of medicines and medical devices in the country. List of ancillary services relating to pharma and medical device industry was also provided for circulation to State Authorities for their clarity.

(v)         The  interventions  of  the  Department  had  resulted  in  timely  issuance  of instructions/  advisories to State/Local  authorities ensuring  that the  production process in the pharmaceutical industry was not hampered and supply of essential medicines in the country was not adversely affected. As per the information provided by  CDSCO, of the  5891  manufacturing  units  operational  in  the  country  in  the  pre Covid-19  situation  only  3222  manufacturing  units  (55.1%)  were  operational  with 39.5% employees working and average daily production of 34.4% during mid-April 2020.  However,  the  situation  improved  since  then.  As  on  01.07.2020,  4797 manufacturing units (81.4%) were operational with 53.49% employees working and had an average daily production of 50.00%.

## F.         Empowered Group-3 ensured production, procurement and availability of essential medical equipment:

The  Empowered  Group-3  took  up  necessary  actions  for  ensuring  availability  and production of essential medical equipment, procurement, import and distribution. At the start of the pandemic, the country did not have or have very negligible number of manufactures  for  PPE  suit,  N-95  masks,  ventilators,  and  testing  kits.  The  Group worked hard to ensure that demand was increasingly fulfilled by domestic manufacturers with the following outcomes:

(i)         PPE KitsInitially the demand was being met through Imports only, but now more than 1200 companies are manufacturing PPE Kits.  More testing labs (10 from just one at the begining of the pandemic) have been added and new types of fabrics developed, supply chain nurtured and more manufacturers helped to validate their products.  The daily production capacity of PPEs has crossed more than 5 lakh per day.   The  county  has  become  the  second  largest  PPE  manufacturer  in  the  world. Export permission also has now been given.

(ii)        N-95 MaskThe production of N-95 Masks in the country was negligible and the demand was being largely met through imports. There is now sufficient number of producers in India. In addition, DRDO has developed two types of masks viz. N-97 & N-99 masks. The production capacity has been enhanced to about 3 lakhs per day.

(iii)        VentilatorsThe  country  had  almost  negligible  ventilators  manufacturing facilities.  Now  we  have  a  number  of  domestic  manufacturers  with  production capacity of more than 3 lakh per annum.  Government is procuring about 97 per cent of the orders from domestic manufacturers (for 58,850 ventilators out of total 60,848 ventilators).  Delivery has started meeting full requirement for management of Covid19.

(iv)       Diagnostic KitsIndia initially imported testing kits and polymer swabs. Now we  have  become  self-reliant  in  swab  availability  as  supply  chain  were  identified, nurtured  and  manufacturing  started  within  India.   With  no  indigenous  capacity  to manufacture RT-PCR based kits and Rapid Diagnostic kits for COVID-19 diagnosis, today the Indian manufacturers stand by the manufacturing capacity of 1334 million kits  per  annum  and  27  million  kits  per  annum  respectively.   Good  number  of domestic companies has also started manufacturing extraction kits, the weak link in testing, first time in India. There is likelihood of allowing exports of these items too.

## 2.         National Institutes of Pharmaceutical Education & Research (NIPERS)

NIPERs were in forefront in sensitizing the various stakeholders and public at large about  the  precautions  to  be  taken  for  controlling  spread  of  COVID.  The  Institutes also undertook various activities like distribution of sanitizers, masks etc.

- (i)         NIPERs at Ahmedabad, Guwahati and Hajipur have been assisting the State Governments  concerned  in  COVID-19  testing.  NIPER  Ahmedabad  has created  a Palliative Care Protocol (PCP), as supportive treatment for COVID-19 In association with  M/s  Troika  Pharma.  The  institute  is  developing a  device  quantum-dots  and conductivity-based biosensors for rapid COVID-19 testing, which would reduce the testing time to 5 mins and could be applied in mass screening. It is also developing new  formulation  of  HCQ  for  delivery  to  lungs.   NIPER  Hyderabad has  been instrumental in development and validation of homology model of potential targets of COVID-19 for screening of existing drugs and new chemical entities in collaboration with IIT Delhi. It is involved in screening of selected antiviral phytoconstituents and Natural chemical entities from Arisaema Genus against various targets of COVID 19. NIPER  Guwahati  has  designed,  developed  &  validated  a  3D-printed  multilayer antimicrobial  face  mask  to control  the  spread  of  novel  coronavirus.  NIPER Mohali  has  developed  Tisane (Herbal  Tea)  as  an  Immune  booster.  NIPERs  have also  contributed  11  COVID  related  publications.  NIPERs  have  signed  3  MoUs  for joint  collaborative  research  for  Covid19  with  the  agencies  and  partners  like  ESIC Medical College Hyderabad, HAL etc. Various webinars involving different experts organized regarding the challenges posed by the COVID 19 and possible solutions and application  of  different  combination  of  drugs  and  supplements  for  its  possible remedies along with immunity boosting.
- (ii)         Besides  these  activities,  NIPERs  have  also  undertaken  various  Research activities that are enumerated as under:

## a.         Ahmedabad

- (i)          Established  ICMR  approved COVID-19 Testing Facility and has conducted quality check & sample testing.
- (ii)        Conducted COVID-19 related webinar on 'Participation in lifestyle and public awareness program through Electronic Media'.
- (iii)       In the process of developing 'Quanum dot based diagnostic tests for COVID19'.
- (iv)       Developing new Nanoformulation of repurposing drugs for COVID-19.
- (v)         Research  on  Grazoprevir  as  a  probable  new  drug  for  COVID-19  to  target viral as well as host protein.
- (vi)       Working on development of Ayurveda based formulation as immunity booster against COVID-19.

## b.         Hyderabad

- (i)         Two Book Chapters were published entitled 'COVID-19 Outbreak: Update on Epidemiology,  Transmission  and  Treatment  Opportunities"  and  'Roles  of  Online Social Media Platforms and Artificial Intelligence in Diffusing the Impact of COVID-19
- as  Scientists  Finds  a  Cure'  in  the  Elsevier  Book  Series  on  'Drug  Discovery Updates'.
- (ii)        Developed noble effervescent formulation of an anti-aging agent.
- (iii)        Cycloencapsulated  and  rographolide  with  improved  physicochemical  and biological characteristics.
- (iv)       Toxicity and safety study was conducted in animal model for the formulation by industry LifeActivus Pvt. Ltd. and Supreme Industry for the treatment of COVID19.
- (v)        Technology Transfer Document between NIPER, Hyderabad, and Lifeactivus Private  Limited,  Hyderabad,  for  the  product  'An  Improved  Process  for  a  Noble Effervescent Formulation of an Anti-Aging Agent'.
- (vi)        Technology  Transfer  Document  between  NIPER,  Hyderabad,  and  Ambe Phytoextracts  Private  Limited,  New  Delhi,  for  the  product  'Cycloencapsulated andrographolide with improved physicochemical and biological characteristics'.
- (viii)     Published 13 research & review paper in reputed journals.
- (ix)       2 MoUs signed for collaborative research work with BBAU, Lucknow, Tenshi KSM Pvt Ltd. Bangalore and LifeActivus Pvt. Ltd., Hyderabad.
- (x)        Filled one Indian patent entitle 'A liquid formulation of chlorine for treatment of COVID-19 and other respiratory viral infection' Application No. 202041028506.

## c.         Raebareli

- (i)         In process of preparing a herbal formulation (in tablet) using various herbs as immune-booster during the treatment of Covid -19.
- (ii)        New compounds belonging to bisthiourea containing bisguanidine class were synthesized  and  remaining  compounds  in  this  series  are  being  synthesized  and purified. These compounds are likely to target the viral RNA of the COVID-19.
- (iii)       A cream based different hand sanitizer formulations using naturally occurring essential  oils  traditionally  acclaimed  for  microbicidal  activity  including  anti-viral activity.
- (iv)       Working on the development of a spray based coating solution to form film on surfaces  comes  in  frequent  contacts  to  prevent  the  growth  of  microorganisms including SARS-CoV-2.
- (v) Working on identification of promising antiviral phytoconstituents of Andrographis paniculata and evaluate their binding affinity against available targets using computational techniques.
- (vi)        Filed  patent  on ' Herbal  hand  sanitizer  hydrogel '  and  ' Coating  solution containing Sodium Chloride and Cetrimide '.
- (vii)       A  manuscript titled as ' Montelukast in combination with Remdesivir may be an Effective Therapeutic Strategy to Control SARS-CoV-2 induced COVID-19 ' has been submitted to the European Journal of Pharmacology and is under review.
- (viii)     Project entitled 'Development and evaluation of immunostimulatory activity of novel herbal formulation' under the scheme 'Anti-SARS-CoV-2/nCoV-2 virus studies using botanical ingredients and traditional formulations' in DBT-BIRAC, New Delhi, worth 38 lakhs (approximately) submitted in July, 2020.

## d.         Mohali

- (i)          Worked  with  Technology  Information,  Forecasting  &  Assessment  Council (TIFAC), DST for the preparation of the report on 'Active Pharmaceutical Ingredients-

Status,  Issues,  Technology  readiness  and  Challenges'  which  was  released  by Hon'ble Minister for S&T, Earth Sciences and Health and Family Welfare.

- (ii)         Research  publication  on  Covid  -  Structure-Based  Virtual  Screening  to Discover  Potential  Lead  Molecules  for  the  SARS-CoV-2  Main  Protease  published from the Institute.
- (iii)        Research  on  identification  and  analysis  the  structural  features  of  enzymes and proteins associated with SARS-CoV-24 initiated.
- (iv)       Concept note prepared for the synthesis of anti-viral agents and new process development for improved synthesis of anti-viral agents, e.g.; remdesivir.
- (v)         One  extramural  research  grant  for  Covid  research  submitted  to  a  funding agency.

## e.         Guwahati

- (i)         Published a review article on progression and treatment against COVID-19 in a peer-reviewed international journal (European journal of Pharmacology) having an impact factor more than 3.0.
- (ii)         Patented '3D printed face protecting device' signed for the mutual nondisclosure  agreement  &  finally  the  technology  is  licensed  to  Hindustan  Antibiotics Limited (HAL).
- (iii)        Computation  studies:  Molecules  which  showed good docking score against COVID  proteins  has  been  submitted  for  anti-viral  screening  to  RCB  laboratories, New Delhi.
- (iv)       Have Supercomputing facility through remote access with PARAM ISHAN to work on various drug development activities including COVID 19.

## f. Kolkata

- (i)         Hand sanitizer was prepared in the Institute laboratory and distributed among the faculties.
- (ii)         In-depth  Analysis,  Phytochemical  identification  and  Network pharmacologybased analysis of three important Indian medicinal plants, Nyctanthes arbor-tristis, Andrographis paniculata & Carica papaya for treating COVID-19 has been carried out by exploiting LC-MS.
- (iii)        Phytochemical  identification  and  Network  pharmacology-based  analysis  of Biogreen winner Capsules by LC-MS for treating COVID-19.
- (iv)        Manuscripts  related  to  Covid-19  research  submitted  to  the  International journals: a). Protease inhibitory effect of natural polyphenolic compounds on SARS CoV II: An in-silico study (Manuscript ID: molecules-908740) b).  Screening of FDA approved drugs of fungal origin that may interfere with SARS CoV II spike protein activation, viral RNA replication and post translational modification: an in silico study (Manuscript Number: JMGM-D-20-00252).
- (v)        In depth analysis of putative active compounds of three important medicinal plants Tinospora cordifol Ziziphus nummularia and Andrographis paniculatahas been carried out using Network Pharmacology based approach focusing.

## 3.         Bureau of Pharma PSUs of India (BPPI)

Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP)

- (i)          In  the  wake  of  COVID-19  crisis, Pradhan  Mantri  Bhartiya  Janaushadhi Pariyojana (PMBJP) has been rendering essential services to the nation. The stores remained  functional  during  lockdown  and  maintained  operations  as  part  of  their commitment  to  ensure  uninterrupted availability of  essential  medicines.  BPPI  has clocked  appreciable  sales turnover  of  Rs.  198.39  crore  in  the  first  four  months  of 2020-21 despite the lock down and testing times as compared to Rs. 103.92 crore achieved in the first four months of 2019-20.
- (ii)         BPPI  has  adequate  stock  of  the  medicines  currently  under  demand,  viz., Face  mask,  Hydroxychloroquine,  Paracetamol  and  Azithromycin.  BPPI  has  sold about  16  lacs Face  masks,  82  lacs  tablets  of  Hydroxychloroquine  in  the  month  of March to August, 2020. Further, orders for 40 lacs Hydroxychloroquine tablets has also  been  placed.  Envisioning  current  market  demand,  BPPI  has  also  placed purchase orders for procurement of these medicines so as to have enough stock for the next six months.
- (iii)       Further, India has always believed in sharing its resources and expertise with its friendly and partnering nations notwithstanding, its own domestic challenges and constraints. The Department has furthered the belief of 'Vasudhaiva Kutumbakam' and  has  so  far  supported  our  neighbouring  countries  in  their  fight  against  the pandemic by providing them stocks of many essential medicines through the Ministry of External Affairs. Complete details of the supplies made are as under: -

## Supply of medicines through Ministry of External Affairs

|   Sl. No. | Name of the Country   |   No. of Medicines supplied | Invoice Value   |
|-----------|-----------------------|-----------------------------|-----------------|
|         1 | Sri Lanka             |                          19 | Rs. 43,65,832/- |
|         2 | Mauritius             |                          26 | Rs. 39,98,147/- |
|         3 | Seychelles            |                          41 | Rs. 72,11,341/- |
|         4 | Nepal                 |                          36 | Rs. 75,15,409/- |
|         5 | Bhutan                |                           5 | Rs. 10,35,811/- |

## Supply of medicines to embassy of friendly countries directly by BPPI

|   Sl. No. | Name of the Country   |   No. of Medicines supplied | Invoice Value   |
|-----------|-----------------------|-----------------------------|-----------------|
|         1 | Uzbekistan            |                           2 | Free Supply     |

Supply of medicines through HLL Lifecare Limited (HLL) to MEA

|   Sl. No. | Name of the Party    |   No. of Medicines supplied | Invoice Value      |
|-----------|----------------------|-----------------------------|--------------------|
|         1 | HLL Lifecare Limited |                          24 | Rs. 10,59,58,939/- |

(iv)       The number of PMBJP stores has increased to 6599 as on 09.09.2020.

(v)        The Scheme has been approved with a budget of Rs. 490 cr. for the period 2020-21 to 2024- 25 with amount of incentives increased from existing Rs. 2.5 lakhs to  up  to  Rs.  5  lakh  to  be  given  @  15%  of  monthly  purchase  made  from  BPPI  by these  JAKs  subject  to  a  ceiling  of  Rs  15,000/-  per  month.  Further,  one-time incentives  of  Rs.  2.00  lakh  is  to  be  provided  to  the  stores  being  opened  in aspirational districts, North-Eastern states or by women/ divyang/ weaker sections of the society.

*****