Drugs (Prices Control) Order, 2013 Amends to Simplify Pricing,
Compliance and Record-Keeping
·
The Ministry of Chemicals & Fertilizers has
notified the Drugs (Prices Control) Amendment Order, 2026 [S.O.
3516(E)], amending the Drugs (Prices Control) Order (DPCO), 2013.
·
The amendment came into force on 30 June 2026,
the date of its publication in the Official Gazette.
Key
Amendments
·
The Government can now fix separate ceiling or
retail prices for the same drug based on:
o
Packaging type,
o
Pack size,
o
Dosage compliance,
o
Contents (liquid, gaseous or other forms), and
o
Therapeutic rationale, provided the drug conforms
to prescribed standards.
·
For scheduled formulations already available in the
market before a ceiling price notification, a manufacturer's overcharging
liability will be limited to the stock held by distributors or retailers
found selling above the notified price, provided the manufacturer has complied
with prescribed price dissemination requirements.
·
Existing manufacturers launching the same new
drug within 12 months of the Government fixing its retail price will no
longer be required to submit a fresh price application. Instead, they must inform
the Government within one month of launch using the newly introduced Form
IA.
·
Manufacturers launching a new scheduled drug at a
price higher than the latest Government-notified retail price will be
liable to:
o
Deposit the overcharged amount,
o
Pay interest from the date of overcharging, and
o
Face applicable penalties.
Price
Revision Compliance
·
To limit overcharging liability, manufacturers must
demonstrate adequate efforts to communicate revised prices by:
o
Circulating revised price lists to dealers and
retailers within two weeks;
o
Publishing advertisements in at least two
national newspapers;
o
Issuing revised or supplementary price lists in Form
V/Form VI;
o
Uploading revised price notifications on the
company's website; and
o
Providing batch-wise production and stock details.
·
Manufacturers are required to issue price lists
and supplementary price lists to State Drug Controllers and the Central
Government, clearly referring to the relevant Government order or Gazette
notification.
Record-Keeping
Requirements
·
Manufacturers must maintain records relating to:
o
Sales of Active Pharmaceutical Ingredients
(APIs)/bulk drugs,
o
Sales of formulation units and packs, and
o
Other records specified by the Government,
for at least seven financial years immediately preceding the current
financial year.
·
Where proceedings are initiated under the DPCO,
such records must be preserved until the proceedings are finally concluded.
New
Compliance Form
·
A new Form IA has been introduced for
manufacturers/importers to intimate the Government regarding the launch of
new drugs, including details such as formulation, composition, launch date,
pack size, therapeutic category, launch price and latest notified Government
price.