NATIONAL PHARMACEUTICAL PRICING AUTHORITY

DEPARTMENT OF PHARMACEUTICALS
MINISTRY OF CHEMICALS & FERTILIZERS
GOVERNMENT OF INDIA

Vol.-IV | APRIL, 2022 A Bi-monthly e-Newsletter

 S.No. Description Page No.

CONTENTS 1.

2.
From Chairman’s Desk

Article by Pharma Expert

1

2-4

3. Regulatory News 5

4. International News 6

5. Other News and Events 7-8

6. Know Your Regulator / Sector 9

7. FAQs 10

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 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.
The Authority is a multi-member body consisting of a Chairperson, a Member Secretary and three ex-officio
members. Two of the three ex-officio members are from Department of Economic Affairs and Department of
Expenditure respectively and third member is Drug Controller General of India.
The Drugs (Prices Control) Order, 2013(DPCO, 2013) was notified on 15.05.2013 under the Essential
Commodities Act, 1955(EC Act, 1955) and is based on the broad guidelines of the National Pharmaceutical
Pricing Policy (NPPP), 2012. The three key principles of the NPPP-2012 are as below:
a. Essentiality of Drugs: The regulation of prices of drugs is on the basis of essentiality of drugs as per the
medicines under NLEM-2011, NLEM-2015 as amended vide S.O. th 701(E) dated 10 March, 2016 has been
incorporated as the First Schedule of DPCO 2013.
b. Control of Formulations prices only: The prices of formulations only are to be regulated and not the prices
of the Bulk Drugs and the resulting formulations as adopted in the Drug Policy 1994.
c. Market Based Pricing: The ceiling prices of medicines are fixed on Market Based Pricing (MBP)
methodology.

EDITORIAL BOARD DISCLAIMER:

Dr. Vinod Kotwal, Member Secretary This is an initiative by NPPA to report current affairs and events related to
Shri Manmohan Sachdeva, Adviser Pharmaceutical industry and the NPPA. This newsletter has been curated purely
Shri G. L. Gupta, Director for informative purposes and do not reflect the official policy or position of NPPA.
Shri Saurabh Bansal, Deputy Director This newsletter is not intended to be used for any commercial/official purposes.

You can also give your suggestions/ feedback at: [email protected]

 From
CHAIRMAN’S DESK
I am happy to bring to you the fourth issue of the NPPA bi-monthly
e-Newsletter.

Department of Pharmaceuticals organized the 7th edition of the

International conference on Pharma and Medical Devices sector
2022 from 25th to 27th April. The theme for India Pharma was: 'India
Pharma-Vision 2047: Transformative agenda for future' and for
India Medical Device, it was ‘Transforming Healthcare through
Innovation & Integrated Services'. This issue highlights the brief
summary of the conference.

This edition has an article written by Dr. Shafiqa Rasool and Dr.
Mohammad Ishaq Geer of University of Kashmir on “Coverage,
utilization and impact of Ayushman Bharat Scheme on access to
medicines in India”. The article explains how as a result of Ayushman
Shri Kamlesh Kumar Pant, IAS
Chairman Bharat scheme, the access including availability and affordability of
National Pharmaceutical Pricing Authority medicines in India has improved.
Department of Pharmaceuticals
Ministry of Chemicals & Fertilizers
Government of India I am also happy to share that NPPA has expanded its reach in one
more State i.e. Himachal Pradesh in March 2022 by setting up Price
Monitoring and Resource Units (PMRUs) there. Thus, the total tally of
PMRUs in the country has reached 23.

NPPA wishes good health to all its readers; stay safe, stay healthy and
follow all COVID appropriate behavior.

With best wishes

(Kamlesh Kumar Pant)

1
 ARTICLE BY PHARMA EXPERTS

COVERAGE, UTILIZATION AND IMPACT OF AYUSHMAN

BHARAT SCHEME ON ACCESS TO MEDICINES IN INDIA
Shafiqa Rasool, Mohammad Ishaq Geer*
Department of Pharmaceutical Sciences, University of Kashmir, Hazratbal, Srinagar-190006, J&K, India
*For Correspondence: Prof. Mohammad Ishaq Geer ([email protected])

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Abstract funded health insurance (PFHI) scheme covering

secondary and tertiary care hospitalization for the

A
yushman Bharat (AB) is a government most deprived 40 percent population of the country.
sponsored health insurance scheme that Around 1350 medical and surgical packages are
aims to cover about 100 million poor and covered under this scheme, which include about all
vulnerable people in India. It provides benefit cover secondary and most of the tertiary care procedures.
of Rs. 5 lakh per family per year with no cap on family As a result of Ayushman Bharat scheme, access
size and the services are portable across the country. including availability and affordability of medicines
This scheme was launched by the Govt. of India in the in India has improved significantly.
year 2018 as a progressive step towards achieving
Universal Health Coverage (UHC). It has two Introduction
interlinked components, namely Health and
Wellness Centres (HWCs) and the Pradhan Mantri Out-of-pocket expenditure (OOPE) on health in India
Jan Arogya Yojana (PMJAY). The former aims to is 62.6% of total health expenditure, which is one of
upgrade sub-centres and primary health centres to the highest in the world and nearly thrice of global
deliver comprehensive primary healthcare to the average of 20.5%. More than two-third of this OOPE
population whereas the latter is a national, publicly- is paid on consultation fees and medicines followed

2
 ARTICLE BY PHARMA EXPERTS
by diagnostic tests. In India more than 300 million These services were expanded keeping in view
people face catastrophic expenditures and around India’s high OOP expenditure. Government of India
50 million people are pushed into poverty every has allocated Rs. 3,200 crore and also envisages
year on account of OOPE on health. One of the contribution of private sector in the form of
main reasons for this is the limited access to corporate social responsibility (5,6). As of 21 March
healthcare services in public sector. The average 2022, a total of 74,947 AB-HWCs were operational
cost per hospitalization is Rs. 20,000 which is more which is set to reach the target of 1.5 lakh by
than annual consumer expenditure of nearly half of December 2022.
our population (1). OOP expenditure on medicines
alone is high and accounts for 70% of total out-of- The other component of Ayushman Bharat covers
pocket expenditure which is more than twice that of large section of the population. The number of
consultation fees and diagnostic services (2). people benefited are double the number benefited
from previously launched health schemes. Once
Ayushman Bharat-PMJAY was launched with an fully functional the benefits of HWCs are expected
aim to protect the population against these very to be available to 100% of population in India.
financial hardships. As per WHO-World Medicines HWCs together with AB-NHPS will be synergistic in
Situation Report of 2004, 65% of Indian population providing healthcare needs across all three levels of
lacked access to medicines at that time (3) but as a care and will also help in increasing accessibility,
result of AB-PMJAY scheme the access to medicines availability and affordability of healthcare and
has considerably improved in India. medicines (7).

Coverage and utilization of health services under Impact of AB PMJAY on access to health services
AB-PMJAY
Various studies on AB-PMJAY have reported mixed
Ayushman Bharat Mission is playing an important responses on financial risk protection. High value of
role in working towards achieving Universal Health greater than Rs. 30,000 and very high value claim of
Coverage (UHC). Unlike previous schemes like greater than Rs. 1,00,000 make up 32% and 9% of
Rashtriya Swasthya Bima Yojana (RSBY) and the PMJAY claim payouts respectively. This is indicative
Senior Citizen Health Insurance Scheme, the AB- of the fact that this scheme has enabled access to
PMJAY has no cap on family size and age (4). The ser vices that would other wise be OOP or
identification of the beneficiaries under this catastrophic to the individual. However, PMJAY
scheme is being done on the basis of the Socio- does not cover out-patient services that account
economic and caste census (SECC), 2011. The for around 60% to 70% of the total OOPE in India
centre–state financing mode is same as in the (8).
National Health Mission. Indian states running
similar schemes have been given an option to In a retrospective study conducted among 160
merge with PMJAY or run it in a parallel manner. patients registered at Ayushman Bharat cell of a
Srinagar-based tertiary care hospital namely
AB-PMJAY covers larger population, provides more SKIMS between 26th December, 2020 and 20th
comprehensive benefit package and incorporates February, 2021, every patient was found to have
a wider hospital network for healthcare delivery. received the benefits of the scheme as a result
The HWCs are committed to provide wider range of w h i c h t h e y h a d to pa y n o t h i n g f o r t h e i r
preventive, promotive, curative and rehabilitative hospitalization and there was no need for them to
healthcare services including treatment and sell their assets or borrow money for treatment
services for non-communicable diseases and thus bringing the prevalence of distress financing
chronic communicable diseases like tuberculosis. to zero level. This was found to be quite contrary to

3
 ARTICLE BY PHARMA EXPERTS
studies conducted by the same authors at the same India, the sixth largest economy and largest
centre before the launch of the scheme wherein democracy of the world has been improving its
prevalence of distress financing amongst cancer health-care facilities slowly since last few decades.
and chronic kidney disease patients was found to As India moves towards the path of UHC, the focus
be more than 70% (9,10,11). should be on reduction of burden due to non-
hospitalization care. High OOP spending on
Discussion and Conclusion medicine needs to be addressed. Use of medicines
should be rationalized and rational prescribing
India has made considerable progress in reducing
encouraged. To significantly reduce OOPE, the
maternal and child mortality under the national
provision for free medicines should be increased
h e a l t h m i s s i o n . Te n to f i f te e n y e a r s a g o
(The Indian Express, 2021). The utilization of
communicable diseases along with maternal and
manpower under Ayushman Bharat has been
nutritional disorders contributed to the major
proved to be successful by way of engagement and
disease burden. Doubling the life expectancy from
potential usage of nearly 1 million ASHA workers
31 years in 1947, when India got its independence
under the National Health Mission (NHM). The
to 68.3 years in 2017. However, in terms of health-
programme provides an innovative initiative of
care access and quality India still stands at 145th
building a highly impactful health model with low
position among 195 countries, lagging behind
cost along with the utilization of skilled workforce.
many countries (12).
All these facts prove that Ayushman Bharat has
been beneficial for the country (13).

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REFERENCES
1. Bhardwaj S. A study of Ayushman Bharat PM-JAY as an enabler of social upliftment. International Journal of Research in Humanities, Arts and Literature
2019: 7(3); 559-564.
2. The long road to Universal health coverage. The Indian Express dated April 24, 2022. (Available at: https://indianexpress.com/article/opinion/the-long-
road-to-universal-health-coverage/) (Accessed on 24.04.2022).
3. World Health Organization. (2004). The world medicines situation, 2nd ed. World Health Organization. WHO/EDM/PAR/2004.5. Available at:
https://apps.who.int/iris/bitstream/handle/10665/68735/WHO_EDM_PAR_2004.5.pdf?sequence=1&isAllowed=y (Accessed on 24.04.2022).
4. Indrani Gupta, Samik Chowdhury, Abhijit Roy, Ramandeep. Ayushman Bharat: Costs and Finances of the Prime Minister’s Jan Arogya Yojana. Economics
and Political Weekly 2020 (4): 36; 56-64.
5. Bajpai N, Wadhwa M. Health and wellness centers: expanding access to comprehensive primary healthcare in India, ICT Indian Working Paper No. 13 dated
July, 2019. (Available at: https://csd.columbia.edu/sites/default/files/content/docs/ICT%20India/Papers/ICT_India_Working_Paper_13.pdf) (Accessed
on 24.04.2022).
6. Vitsupakorn S, Bharali I, Kumar P, Yamey G, Mao W. Early experiences of PM-JAY in India: A narrative review. Duke Global Working Paper: 30 march 2021.
(Available at: https://centerforpolicyimpact.org/wp-content/uploads/sites/18/2021/02/PMJAY_FINAL.pdf) (Accessed on 24.04.2022)
7. Lahariya C. ‘Ayushman Bharat’ Program and Universal Health Coverage in India. Indian Pediatrics 2018:55;495-506.
8. Garg S, Bebarta KK, Tripathi N. Performance of India’s national publicly funded health insurance scheme, Pradhan Mantri Jan Arogaya Yojana (PMJAY), in
improving access and financial protection for hospital care: findings from household surveys in Chhattisgarh state. BMC Public Health (2020) 20:949
(https://doi.org/10.1186/s12889-020-09107-4).
9. Abas Khan, Farooq Jan, Haroon Rashid. Prevalence of distress financing and catastrophic health expenditure among end stage renal disease patients
attending a tertiary care teaching hospital of north India. Biomedical Journal of Scientific & Technical Research 2020: 32(4); 25133-35.
10. Abas Khan, Farooq A Jan, Haroon Rashid, Arshad Manzoor Najmi, Imtiyaz Ahmed Wani. Prevalence of distress financing and catastrophic health
expenditure in cancer patients: a study from India. European Journal of Pharmaceutical and Medical Research 2020;7(12); 384-386.
11. Abas Khan, Yatoo, G. H., Mohd Sarwar Mir. Impact of Ayushman Bharat scheme on the prevalence of distress financing and catastrophic health expenditure
among patients attending a tertiary care teaching hospital. Rivista Medicine 2021:1;11-15.
12. Mehta V. Ayushman Bharat Initiative: India’s answer to provide Universal Health Care. Journal of Medical Research and Innovation 2019;3(1):e000148.
13. Venkatesh U, Mogan KA, Mukesh Kumar, PreetyDoley, Jugal Kishore. Ayushman Bharat is a boon for the country. Motion International Journal of
Preventive, Curative & Community Medicine 2019:5(3);31-35.

44
 REGULATORY NEWS
News related to pricing of drugs

Ü As on 31.03.2022, over all 228 Authority fixed under DPCO, 2013 till 31st March, 2022.
meetings have been conducted and out of Ü Ceiling prices of 888 scheduled formulation
which 96 are under DPCO 2013. The 228th (National List of Essential Medicines, 2015)
(Overall). The 96th meeting of the Authority revised based on WPI @ 10.76607% (to be
under DPCO 2013 was held on 24.03.2022. applicable from 01.04.2022.
Ü Ceiling prices for 887 scheduled Details of Ceiling prices fixed for various
formulations (National List of Essential formulations in 96th Authority Meetings are as
Medicines, 2015) and Retail prices for 1873 follows:
non-scheduled formulations have been

Sl. Name of the Dosage form Unit Ceiling Revised Ceiling Price Category
No. Scheduled Formulation & Strength Price (Rs.) (Rs. W.e.f. 01.04.2022)
(1) (2) (3) (4) (5) (6) (7)
1 Framycetin Cream 0.5% 1 GM 1.07 1.19 Antibiotic

Ü Retail prices of 56 new drugs for various period of 5 years from the date of
pharmaceutical companies were fixed in the 96th commencement of its commercial production
meeting of the Authority under DPCO 2013 in the country subject to it being co-terminus
respectively. with the duration of Indian Patent.
Ü During the 96th meeting of the Authority under
Sl. Drug Extended Till Effective
DPCO 2013, the prices of following items were No. Order
also extended in public interest: 1 Heparin Injection 30.09.2022 or S.O. 1507€
Details of Retail prices fixed for various formulations 5000IU/ml and until further order dated
in 96th Authority Meetings are as follows: 1000IU/ ml whichever is earlier 30.03.2022
2 Liquid Medical Oxygen 30.06.2022 or S.O. 1508€
S. Therapeutic Total Type of Retail Price (LMO) and Oxygen until further order dated
No. group Number formulation Fixed Range Inhalation (Medicinal whichever is earlier 30.03.2022
(Rs.) gas) in cylinder
(1) (2) (3) (4) (5)
News related to pricing of Medical devices
1 Anti-Diabetic 30 Tablet 5.63 – 20.025
2 Antihypertensive 4 Tablet 9.94 – 15.67
Ü NPPA vide Gazette Notifications No. S.O.
3 Cardio Vascular 1 Tablet 30.38 1502(E), S. O. 1503(E), S. O. 1499(E) dated 30th
4 Hypertension 2 Tablet 4.465-6.697 March 2022 notified the revised ceiling price
5 Anti- bacterial 2 Infusion 1.32 – 7.42 of medical devices as per the Annual
6 Pain Analgesic 5 Tablet/Gel/ 1.52 – 40.18 Wholesale Price Index (WPI) @ 10.76607% as
Spray/Patch tabulated below:
7 Others 12 Tablet/ 3.27
Infusion/ SI. Medical Device Unit Ceiling price
Injection No. (in No.) (in Rs.)*
1 Bare Metal Stents 1 9373.03
Ü Exemption granted to M/s Serum Institute of
2 Drug Eluting Stents (DES) including 1 34128.13
India Private Limited under Para 32 (ii) of DPCO, metallic DES and Bioresorbable
2013 for their formulation “Pneumococcal Vascular Scaffold (BVS)/
Biodegradable Stents
Polysaccharide Conjugate Vaccine (Adsorbed)
IP (10-Valent) (PCV 10V)” in (i) single dose 3 Condoms 1 10.14

(0.5ml) vials, (ii) multi-dose (2.5ml) vial, and (iii) 4 IUD containing Copper 1 319.22
single dose (0.5ml) pre-filled syringes for a 5 Hormone releasing IUD 1 4295.01

5
INTERNATIONAL NEWS
FDA Approves First Generic of Symbicort to Treat death and hospitalization in patients with heart
Asthma and COPD (March 15,2022) failure and low ejection fraction.
Read more
The US, Food and Drug Administration approved
the first generic of Symbicort (budesonide and EMA establishes Cancer Medicines Forum with
formoterol fumarate dihydrate) Inhalation Aerosol academia to optimise cancer treatments in
for the treatment of two common pulmonary clinical practice (March 31, 2022)
health conditions: asthma in patients six years of
age and older; and the maintenance treatment of The EU, EMA, in collaboration with the European
airflow obstruction and reducing exacerbations for Organisation for Research and Treatment of
patients with chronic obstructive pulmonary Cancer (EORTC), has launched the Cancer
disease (COPD), including chronic bronchitis Medicines Forum (CMF). Bringing together
and/or emphysema. This complex generic drug- representatives from academic organisations and
device combination product, which is a metered- the European medicines regulatory network, the
dose inhaler, should not be used to treat acute forum aims at advancing research into optimising
asthma attacks. cancer treatments and will contribute to foster high
Read more standards in cancer care in the European Union (EU)
.
FDA Authorizes Second Booster Dose of Two Since its establishment in 1995, EMA has reviewed
COVID-19 Vaccines for Older and Immuno- and recommended for approval over 170 cancer
compromised Individuals (March 29, 2022) medicines that have gone on to play an important
role in the treatment and management of various
The U.S. Food and Drug Administration authorized types of cancers. The field of oncology has seen the
a second booster dose of either the Pfizer- emergence of major innovations in recent years,
BioNTech or the Moderna COVID-19 vaccines for including the arrival of personalised medicines,
older people and certain immunocompromised immunotherapies, and advanced therapy
individuals. The FDA previously authorized a single medicinal products. Such innovations have helped
booster dose for certain immunocompromised cancer patients across Europe by offering them
individuals following completion of a three-dose new tools in their fight against the disease.
primary vaccination series. This action will now However, at the time new medicines enter the
make a second booster dose of these vaccines market, there is an opportunity to improve many
available to other populations at higher risk for aspects with respect to their optimal use and
severe disease, hospitalization and death. integration into the existing array of treatments.
Emerging evidence suggests that a second Addressing these opportunities for treatment
booster dose of an mRNA COVID-19 vaccine optimisation may require the conduct of studies to
improves protection against severe COVID-19 and collect robust data to further guide clinical practice.
is not associated with new safety concerns.
Read more MHRA approves the Moderna COVID-19 vaccine
‘Spikevax’ for use in 6- to 11-year-olds (14 April
FDA Approves Treatment for Wider Range of 2022)
Patients with Heart Failure (February 24, 2022)
UK, MHRA (The Medicines and Healthcare
The U.S. Food and Drug Administration approved products Regulatory Agency) has approved an
Jardiance (empagliflozin) to reduce the risk of update to the current UK approval of the Moderna
cardiovascular death and hospitalization for heart COVID-19 Vaccine, or ‘Spikevax’, that allows its use
failure in adults. Jardiance was originally approved in Great Britain (GB) in 6- to 11-year-olds. This
by the FDA in 2014 as a supplement to diet and approval takes into account the extension to use in
exercise to improve glucose control in adults with children aged 6 to 11 years already approved by
type 2 diabetes. Jardiance is also approved to the European Medicines Agency on 2 March 2022,
reduce the risk of cardiovascular death in adults as the original GB licence for Spikevax in adults was
with type 2 diabetes and established approved by relying on the EU decision.
cardiovascular disease, and to reduce the risk of Read more

12
6
 OTHER NEWS AND EVENTS
NPPA sets up 23rd PMRU in Union Territory of Himachal Pradesh in
March, 2022

NPPA under Consumer Awareness, Publicity and Price Monitoring

(CAPPM) Scheme has so far set-up Price Monitoring and Resource Units
(PMRU) in 23 States/UTs. The 23rd PMRU was established in the State of
Himachal Pradesh on 22.03.2022. Now, NPPA has its presence in
following states/UTs viz. Kerala, Gujarat, Odisha, Rajasthan, Punjab,
Nagaland, Tripura, Uttar Pradesh, Mizoram, Jammu & Kashmir, Andhra
Pradesh, Haryana, Karnataka, Telangana, Maharashtra, Goa, Madhya
Pradesh, Chhattisgarh, Jharkhand, West Bengal, Puducherry, Ladakh
and Himachal Pradesh. This will help NPPA to trickle down the benefits
of DPCO, 2013 at grass-root level with the help of PMRU to ensure that
consumer at large is benefited.

Activities done by PMRU’s

During the month of February and March 2022, NPPA has organized six (6) webinars with different PMRUs,
details of which are as follows-
S. No. Date Subject of Webinar
1 24.02.2022 Webinar on “Guidance on Functioning of New PMRUs” with six PMRUs viz. Chhattisgarh,
Jharkhand, Madhya Pradesh, Puducherry, West Bengal and Ladakh.
2 15.03.2022 Webinar on “Functioning and Review of New PMRUs” for 11 PMRUs viz. Odisha, Rajasthan,
Andhra Pradesh, Karnataka, Telangana, Maharashtra, Goa, Chhattisgarh, Jharkhand, West
Bengal and Puducherry
3 16.03.2022 Webinar on “Functioning and Review of New PMRUs” for 11 PMRUs viz. Kerala, Gujarat, Punjab,
Haryana, Uttar Pradesh, Madhya Pradesh, Nagaland, Mizoram, Tripura, Ladakh and Jammu &
Kashmir.
4 25.03.2022 Webinar with PMRU Ladakh to assist them to commence functioning.
5 30.03.2022 Webinar with PMRUs introducing them IPDMS 2.0
6 31.03.2022 Webinar with PMRU Himachal Pradesh on “Guidance on Functioning of New PMRUs”

7
 OTHER NEWS AND EVENTS
7th EDITION OF INTERNATIONAL CONFERENCE ON
PHARMA AND MEDICAL DEVICES SECTOR 2022 Speaking on the occasion Shri Bhagwanth Khuba,
Union Minister of State of Chemicals and Fertilisers
The 7th edition of International conference on noted that India is the pharma hub of the world with
Pharma & Medical Device 2022 was organized by India's production being 5th in the world. He further
the Department of Pharmaceuticals, Ministry of noted that the Indian Medical sector currently
Chemicals & Fertilizers, Govt of India with the standing at $11 billion and is likely to reach $50
Federation of Indian Chambers of Commerce and billion by 2025.
Industry (FICCI) during 25-27 April 2022.The annual
flagship three-day conference was held at Dr M s . S . A pa r n a , S e c re t a r y, D e pa r t m e n t of
Ambedkar International Centre, New Delhi. Pharmaceuticals while addressing the event
emphasized the need to build an ecosystem for
Union Minister for Chemicals & Fertilizers and innovation in medical devices and drugs along-
Health & Family Welfare, Dr. Mansukh Mandaviya with enhanced industry-academia linkages.
inaugurated the International conference on
Pharma and Medical Devices sector 2022 on 25th At the inaugural ceremony, three knowledge
April 2022 in the presence of Shri Bhagwanth documents- ‘Impact of the pharma industry on the
Khuba, Minister of State for Chemicals and Indian ecosystem in the post- COVID era’, ‘Enabling
Fertilisers. New and Renewable Energy, and other Growth and innovation in the Indian Medical
dignitaries. Dr. V.K. Paul, Member, NITI Aayog, Ms. S. Devices Sector’ and a ‘Compilation of important
Aparna, Secretary, Department of Pharmaceuticals, speeches by CEOs’ were also released by the Union
Dr. Balram Bhargava, Director General, ICMR, senior Minister. In addition to this, Dr. Mansukh
officials from government, FICCI and Invest India Mandaviya also chaired two roundtable
and CEOs of various Pharma and medical devices conferences with the Pharma and Medical Devices
companies were also present at the conference. CEOs after the inaugural ceremony.

Addressing the event, Dr. Mansukh Mandaviya, On day two of the conference, Shri Rajesh
Union Minister of Health and Family Welfare and Bhushan, Secretary, Department of Health and
Chemicals and Fertilizers highlighted that the Family Welfare Health Secretary and Ms. S. Aparna,
government has been working relentlessly to Secretary, Department of Pharmaceuticals chaired
increase the number of doctor s, medical a panel discussion with the pharmaceuticals
institutions, health infrastructure including industry CEOs in the presence of Shri Anurag Jain,
hospital, tertiary care centres, health and wellness Secretary, DPIIT on the theme 'Indian Pharma
centres in the country. “Conferences like India Vision 2047'. Shri Kamlesh Kumar Pant, Chairman,
Pharma and India Medical Device 2022 provide a NPPA was also part of the panel discussion in the
platform for industry, academia and policy makers sessions on “Building Resilient Supply Chains” and
to brainstorm and draft a plan for the next 25 years “R&D and innovation in Medtech: Some Success
for the sector,” he added. Stores”

8
 KNOW YOUR REGULATOR/SECTOR

UNDERSTANDING INDIAN DRUG MARKET

As per the provisions of DPCO 2013, Drugs are categorized as scheduled and non-scheduled formulation.
Further, prices of certain Non-scheduled drugs are fixed under Para 19 of DPCO, 2013. During 2021-22, the
market share of various categories of drugs is as follows:

ROW LABELS SCHEDULED NON-SCHEDULED PRICE FIXED GRAND

DRUGS DRUGS IN PARA-19 TOTAL
Market share in terms of Revenue 17.45% 80.49% 2.06% 100.00%
Market share in terms of Quantity sold 31.09% 67.65% 1.26% 100.00%

The share of above Drug categories for each Drug group is as follows:

ROW LABELS SCHEDULED NON-SCHEDULED PRICE FIXED GRAND

DRUGS DRUGS IN PARA-19 TOTAL
ANTI MALARIALS 58.02% 41.98% - 100.00%
ANTI-NEOPLASTICS 51.21% 48.79% - 100.00%
HORMONES 43.05% 56.95% - 100.00%
CARDIAC 20.33% 67.14% 12.53% 100.00%
ANTI-INFECTIVES 32.44% 67.56% - 100.00%
NEURO / CNS 24.44% 75.56% - 100.00%
BLOOD RELATED 23.64% 76.36% - 100.00%
OPHTHAL / OTOLOGICALS 19.37% 80.63% - 100.00%
VACCINES 18.77% 81.23% - 100.00%
PAIN / ANALGESICS 16.72% 83.28% - 100.00%
GYNAECOLOGICAL 13.01% 86.99% - 100.00%
GASTRO INTESTINAL 12.88% 87.12% - 100.00%
ANTI DIABETIC 7.14% 89.37% 3.49% 100.00%
RESPIRATORY 10.58% 89.42% - 100.00%
DERMA 5.39% 94.61% - 100.00%
VITAMINS / MINERALS / NUTRIENTS 4.83% 95.17% - 100.00%
OTHERS 3.29% 96.71% - 100.00%
UROLOGY 1.67% 98.33% - 100.00%
SEX STIMULANTS / REJUVENATORS - 100.00% - 100.00%
STOMATOLOGICALS - 100.00% - 100.00%
Grand Total 17.45% 80.49% 2.06% 100.00%

Source: Pharmatrac database, March 2022

9
• Whether any approval is required from NPPA for
launching a Drug?

No, approval of NPPA is not required for launching a

Drug. However, where an existing manufacturer of a
Scheduled drug launches a new drug, such existing
manufacturer shall apply to NPPA for obtaining Retail
Price, prior to the launch of such new drug.

• Does New Drug mean all newly launched drugs?

No. Under DPCO, 2013, New Drug means a

formulation launched by an existing manufacturer by
combining a scheduled drug with another drug or by
changing the strength or dosages or both of a
scheduled drug.

• Is Retail Price and Maximum Retail Price (MRP) one

and the same thing?

No. Retail Price under DPCO, 2013 means the Price

given by NPPA for a New Drug. The manufacturer of a
New Drug can fix the MRP up to Retail Price plus local
taxes and duties as applicable.

• Whether Retail Price is to be obtained by an

existing manufacturer in case NPPA has already
fixed the Retail Price of such formulation for some
other manufacturer?

Yes, Retail Price needs to be obtained by all existing

manufacturers in respect of all New Drugs separately.

• What if a manufacturer launches a New Drug

without obtaining Retail Price from NPPA?

` In such a case, the Retail Price shall be fixed by NPPA

and the overcharged amount shall be recovered
from the manufacturer along with interest and
penalty. Further, action can also be taken under
Section 7 of the Essential Commodities Act, 1955.

10
Feedback and
Complaint Redressal

Grievance Redressal

Pharma Jan Samadhan: A web enabled system for

grievance redressal – catering to consumers,
distributors, dealers, retailers.

Information Dissemination

Pharma Sahi Daam: One can easily search

brand name, composition, ceiling price and
MRP of the formulation – available to public.
Seminars and Workshops conducted by
NPPA and by PMRUs

Collaboration with State

Governments
PMRU: To help NPPA to monitor notified
prices and ensure availability of medicines.
To spread awareness regarding the pricing of
drugs, etc.

11
 NATIONAL PHARMACEUTICAL PRICING AUTHORITY
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