Drug Price Control Order explained for pharma compliance
India's Drug Price Control Order regulates medicine prices. Learn how DPCO 1995 differs from DPCO 2013 and what scheduled formulations mean for pricing.
The Drug Price Control Order, or DPCO, is India's framework for regulating medicine prices. DPCO 2013 moved control away from the older DPCO 1995 bulk-drug approach and towards essential-medicine formulations. The Government described the newer method as market-based pricing in its December 2013 review. NPPA's December 2024 newsletter explains the shift to formulation prices, rather than bulk-drug prices.
For a pharmaceutical compliance team, the distinction affects which source answers a pricing question. NPPA's historical bulk-drug list explains the older framework. It does not establish today's coverage or the permitted price of a particular formulation. Those checks require the operative Schedule, relevant amendments and applicable NPPA price notification.
What does DPCO mean in pharmacy?
DPCO stands for Drugs (Prices Control) Order. The official title of the newer framework is the Drugs (Prices Control) Order, 2013, as listed in NPPA's document register.
Searches for "DPCO Act" refer to this framework, but DPCO is an Order rather than a separate Act. The Government's 22 July 2022 explanation identifies the Essential Commodities Act, 1955 as its legal basis. It also identifies the National Pharmaceutical Pricing Authority, or NPPA, as the administering authority attached to the Department of Pharmaceuticals.
The full form is the same in pharmacy, medical and pharmaceutical-jurisprudence discussions. In a compliance record, use the official title and identify the relevant paragraph or notification. Calling a provision a "section of the DPCO Act" confuses the Order with its parent legislation.
What changed between DPCO 1995 and DPCO 2013?
The older framework linked price control to listed bulk drugs and formulations containing them. NPPA's legacy FAQ describes that approach. Read it as an explanation of the historical system, rather than a current list of controlled medicines.
The Government's 19 December 2013 review described earlier DPCOs, including DPCO 1995, as cost-based. It described the newer approach as market-based. This is the main pricing distinction between the two frameworks.
There was also a change in the focus of control. NPPA's December 2024 newsletter explains the policy of regulating formulation prices, rather than bulk-drug prices and the resulting formulations under the older policy. An old bulk-drug entry therefore cannot answer a formulation-pricing question by itself.
For essential medicines, Schedule I is the relevant starting point. The Government's February 2025 explanation connects that Schedule with the National List of Essential Medicines, NLEM 2022. NPPA's document register separately lists the November 2022 amendment labelled NLEM 2022. Check the formulation's Schedule entry, not just whether its active ingredient appears in a familiar medicine list.
Why does the historical list show 76 bulk drugs?
NPPA's List of Bulk Drugs Under DPCO 1995 contains 76 numbered entries. It starts with sulphamethoxazole and ends with mefenamic acid. The page also records subsequent deletions, so the numbering needs to be read with its footnote.
Two entries carry asterisks: No. 56, amikacin sulphate, and No. 76, mefenamic acid. The footnote states that they were deleted by SO 626(E), dated 2 September 1997. Sulphamethoxazole does not carry that deletion marker.
Use this page to document the history of the DPCO 1995 list. Do not describe it as 76 medicines controlled today, or assume every numbered entry remained controlled throughout that regime. The page is dated 5 September 2018, but its subject remains the historical framework.
Scheduled and non-scheduled formulations under DPCO 2013
A formulation's status determines which pricing route to examine. The Government's 30 July 2024 explanation distinguishes formulations included in Schedule I from those outside it. It says both categories fall within DPCO 2013.
| Scheduled formulations | Non-scheduled formulations |
|---|---|
| Included in Schedule I. | Not included in Schedule I. |
| NPPA fixes ceiling prices, as explained by the Government in February 2025. | Manufacturers may set the initial MRP. Later increases stay subject to monitoring. |
| The February 2025 explanation says branded and generic manufacturers must sell within the ceiling plus applicable GST. | The same explanation describes a limit on MRP increases over the preceding 12 months. |
Sources: Government explanations of July 2024 and February 2025.
What does the 10% explanation mean?
In its 7 February 2025 release, the Government said non-scheduled manufacturers must not increase MRP by more than 10% during the preceding 12 months. The July 2024 explanation identifies paragraph 20 as the non-scheduled monitoring provision.
"Preceding 12 months" means a rolling period in the February 2025 explanation. Do not read that wording as permission to reset the increase each January. Nor does the explanation establish a right to apply that increase to scheduled medicines. Their ceiling-price route is different.
These are dated government explanations. Before using the percentage for a price decision, check the operative provisions and subsequent amendments. A dated explanation is useful context, but it does not replace the legal text applicable to the proposed change.
Does non-scheduled mean unregulated?
No. The February 2025 release also describes possible public-interest ceiling prices. Do not assume non-scheduled products can never face a ceiling. Separately, the release describes manufacturer- or marketer-specific retail prices for a DPCO-defined "new drug."
Keep initial MRP setting separate from later increases. The February 2025 explanation permits manufacturers to set initial MRPs for non-scheduled formulations, while still describing limits on subsequent increases. Neither statement supports treating those formulations as outside DPCO altogether.
Which documents should a compliance team check?
Start with the question being answered. For historical bulk-drug coverage, use the DPCO 1995 list and its deletion footnote. For a formulation's pricing status, check the operative Schedule and relevant amendments, then the NPPA notification for that formulation. A medicine name alone does not settle whether every strength or dosage form is covered.
The document date can cause confusion. NPPA's register lists a DPCO 2013 consolidation amended up to 25 May 2023. It also lists the 13th DPCO 2013 Amendment dated 30 June 2026. The Department of Pharmaceuticals Acts register lists that consolidation and a 2026 amendment. The 2023 text isn't a complete November 2026 legal text on its own. A later website date does not make an older consolidation current. A register entry shows that an amendment exists, not what each provision does.
If the team classifies a formulation as scheduled, keep the Schedule reference beside the ceiling-price notification. If it classifies the formulation as non-scheduled, record that basis before assessing an MRP increase. Keep the old bulk-drug list with the history: it can explain an earlier assessment, but it cannot support a new price decision. Date each government explanation, so a later reviewer does not treat a 2024 or February 2025 release as the consolidated Order.
Search labels such as "DPCO 2017" or "Drug Price Control Order 2020" do not name an instrument by themselves. Use the official registers, then read the instrument.
For a plain-language starting point, RegAffairs AI answers this DPCO question with source citations. The applicable formulation price comes from the relevant NPPA notification, read with the operative Schedule and amendments.