Paracetamol is not Banned,
says Health Minister
·
The Ministry of Health and Family
Welfare has informed that the Central Drugs Standard Control Organisation is
not in receipt of information about rumours regarding drug paracetamol ban
·
The National Pharmaceutical Pricing
Authority (NPPA) under the Department of Pharmaceuticals fixes and monitors the
prices of drugs, including OTC drugs, under the Drugs (Prices Control) Order,
2013 (“DPCO, 2013”)
Ministry
of Health and Family Welfare
regarding Paracetamol,
drug pricing, and essential drug availability:
·
The Central Drugs Standard Control
Organisation (CDSCO) confirms:
o Paracetamol is not banned in India.
o Some Fixed Dose Combinations (FDCs) involving
Paracetamol have been banned.
o The list
of banned combinations is available on CDSCO’s website: www.cdsco.gov.in.
Under the Drugs (Prices Control) Order, 2013
(DPCO, 2013), the National
Pharmaceutical Pricing Authority (NPPA) regulates prices:
·
Ceiling
price fixed for drugs listed in the National
List of Essential Medicines (NLEM).
·
Prices
revised annually based on Wholesale
Price Index (WPI).
·
Applicable
to all manufacturers, importers, and marketers.
·
NPPA
sets retail price
for formulations that are:
o New combinations
o Changed strength/dosage of NLEM drugs
·
Applicable
only to the applicant manufacturer.
·
Price
hike limited to 10%
annually.
·
NPPA
monitors Maximum Retail
Price (MRP) to ensure compliance.
To
reduce out-of-pocket
expenditure, the Government supports States/UTs to:
·
Provide
free essential medicines
at public health facilities (including rural PHCs).
·
Support
covers:
o Procurement and distribution
o Quality assurance, warehousing,
and grievance redressal
o Promotion of Standard Treatment Guidelines
o Rollout of Drugs and Vaccine Distribution Management System (DVDMS)
for real-time monitoring
o Central dashboard enables nationwide supply chain monitoring
Recommended
facility-wise EML
for public healthcare institutions:
|
Facility
Type |
No.
of Essential Medicines |
|
Sub
Health Centres (SHCs) |
106 |
|
Primary
Health Centres (PHCs) |
172 |
|
Community
Health Centres (CHCs) |
300 |
|
Sub-District
Hospitals |
318 |
|
District
Hospitals |
381 |
·
States
may expand these
lists based on local needs.
·
Active
rate contracts for 697 formulations
·
1,152
registered indenters
(govt. hospitals, PHCs, etc.)
·
Drugs
can be ordered four times
a year via MSO-DVDMS
application
The
Ministry of Health and Family Welfare has informed that the Central Drugs
Standard Control Organisation is not in receipt of information about such
rumours. It has further informed that the drug Paracetamol is not banned in the
country, although in the recent past various Fixed Dose Combinations, including
such combinations of Paracetamol with other drugs, have been banned in the
country, and the list of all such banned combinations is available on the
website of the Central Drugs Standard Control Organisation (www.cdsco.gov.in ).
The
National Pharmaceutical Pricing Authority (NPPA) under the Department of
Pharmaceuticals fixes and monitors the prices of drugs, including OTC drugs,
under the Drugs (Prices Control) Order, 2013 (“DPCO, 2013”), in the following
manner:
i.
For
formulations that are listed in the National List of Essential Medicines issued
by the Department of Health and Family Welfare and incorporated in the First
Schedule to DPCO, 2013, including OTC formulations, NPPA fixes the ceiling
price and revises them annually based on the Wholesale Price Index (all
commodities). All manufactures, importers and marketers of scheduled medicines
are required to sell their products within the ceiling price (plus applicable
local taxes) fixed.
ii.
For
new drugs (i.e., formulations launched by existing manufacturers of a medicine
listed in NLEM by combining it with another drug, or by changing the strength
or dosage or both of such medicine), including OTC drugs, NPPA fixes the retail
price. Such retail price is applicable to the applicant manufacturer and
marketer, who are required to sell these drugs within the retail price fixed.
iii.
For
other non-scheduled formulations, including non-scheduled OTC formulations,
manufacturers are required not to increase the maximum retail price (MRP) of
such formulations launched by them by more than 10% of MRP during the preceding
12 months, and NPPA monitors their MRP with a view to ensure the same.
The
Ministry of Health and Family Welfare has informed that to ensure availability
of essential drugs and reduce out-of-pocket expenditure of patients visiting
the public health facilities, including government hospitals and rural primary
health centres, Government has rolled out the Free Drugs Service Initiative
under the National Health Mission. Under this, financial support is provided to
States and Union territories for provision of free essential medicines in
public health facilities based on the requirements posed by them in their
Programme Implementation Plans within their overall resource envelope for the
said Mission. Support under the said initiative is available for procurement of
drugs and strengthening or setting up of robust systems of procurement, quality
assurance, supply chain management and warehousing, prescription audit and
grievance redressal, and for the dissemination of standard treatment guidelines
and establishment of the information-technology enabled platform named Drugs
and Vaccine Distribution Management System (DVDMS), which is used for
monitoring the actual status of procurement and availability of essential
medicines. To facilitate monitoring of supply chain management activity at the
national level, a central dashboard has been developed. Some States have also
implemented the roll-out of the DVDMS portal till Sub Health Centres for
monitoring the status of procurement and availability of essential medicines.
The
Ministry of Health and Family Welfare has recommended facility-wise Essential
Medicines List to be made available at public healthcare facilities, including
government hospitals and rural primary health centres. The recommended
Essential Medicines List for Sub Health Centres, Primary Health Centres,
Community Health Centres, Sub-District Hospitals and District Hospitals consist
of 106, 172, 300, 318 and 381 drugs respectively, with flexibility to States to
add more medicines.
To
ensure uninterrupted supply chain of essential drugs in government hospitals
and rural health facilities, the Medical Stores Organisation (MSO) / Government
Medical Store Depots (GMSDs) has active rate contracts for 697 drug
formulations. MSO has 1,152 registered indenters across India, including
government hospitals and rural primary health centres, who may place demands
for supply of drugs to MSO/GMSDs through MSO-DVDMS application software four
times in a financial year.
This
information was given by the Union Minister of State for Chemicals and
Fertilizers Smt Anupriya Patel in Rajya Sabha in
reply to a question on 5 August, 2025.