As B.Pharm students, understanding the Objectives of Drugs Price Control Order (DPCO) 2013 is essential for grasping pharmaceutical pricing, public health policy, and regulatory compliance. DPCO 2013 aims to ensure affordable access to essential medicines by setting ceiling prices, preventing unjustified profit margins, and promoting transparency in the drug market. Key elements include identification of scheduled formulations, role of NPPA, methods for price fixation and revision, and safeguards against market exploitation. Mastery of these objectives helps future pharmacists navigate pricing regulations, support rational drug use, and contribute to equitable healthcare delivery. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. What is the primary objective of DPCO 2013?
- To encourage exports of pharmaceutical formulations
- To ensure affordable access to essential medicines
- To regulate clinical trial approvals
- To set manufacturing quality standards
Correct Answer: To ensure affordable access to essential medicines
Q2. Which authority is responsible for implementing DPCO 2013 in India?
- Central Drugs Standard Control Organization (CDSCO)
- Pharmaceuticals Export Promotion Council (Pharmexcil)
- National Pharmaceutical Pricing Authority (NPPA)
- Drug Controller General of India (DCGI)
Correct Answer: National Pharmaceutical Pricing Authority (NPPA)
Q3. Under DPCO 2013, “scheduled formulations” refers to:
- All medical devices sold in India
- Formulations listed for price control by the government
- Only injectable formulations
- Herbal and traditional medicines
Correct Answer: Formulations listed for price control by the government
Q4. DPCO 2013 primarily uses which method to fix ceiling prices for scheduled formulations?
- Cost-plus method based on manufacturer’s declared costs
- Reference price method based on simple average of market prices
- Market-based ceiling price using average of prices of brands with at least 1% market share
- International reference pricing based on OECD countries
Correct Answer: Market-based ceiling price using average of prices of brands with at least 1% market share
Q5. The NPPA determines ceiling price by taking the average price of how many top priced brands? (per DPCO 2013 methodology)
- The single highest priced brand
- All brands available in the market
- Brands having market share of at least 1%
- Top five brands irrespective of market share
Correct Answer: Brands having market share of at least 1%
Q6. Which list is commonly referenced for selecting essential medicines under DPCO 2013?
- WHO Model List of Essential Medicines only
- National List of Essential Medicines (NLEM)
- Indian Pharmacopeia Supplement
- FDA Orange Book
Correct Answer: National List of Essential Medicines (NLEM)
Q7. DPCO 2013 replaced which older price control order?
- Drugs Price Control Order (DPCO) 1995
- Essential Commodities Order 2001
- Pharma Pricing Order 2009
- There was no previous order
Correct Answer: Drugs Price Control Order (DPCO) 1995
Q8. Which of the following is NOT an objective of DPCO 2013?
- To prevent exploitation by manufacturers through excessive pricing
- To ensure uniform quality of all pharmaceutical products
- To increase transparency in price fixation
- To make essential medicines affordable and accessible
Correct Answer: To ensure uniform quality of all pharmaceutical products
Q9. Under DPCO 2013, how often can NPPA revise ceiling prices through government notification?
- Only once every ten years
- As and when required based on market/industry changes
- Every month without restriction
- Never; prices are permanent
Correct Answer: As and when required based on market/industry changes
Q10. Which factor is explicitly considered by NPPA while calculating ceiling price under DPCO 2013?
- Manufacturer’s production cost data submitted confidentially
- Average retail price to wholesalers without any selection
- Overall market-based price of comparable formulations
- International wholesale price indices only
Correct Answer: Overall market-based price of comparable formulations
Q11. DPCO 2013 aims to balance which two major public policy goals?
- Maximizing government revenue and minimizing drug use
- Promoting exports and restricting imports
- Ensuring affordability and maintaining availability of medicines
- Strict price controls and banning private pharmacies
Correct Answer: Ensuring affordability and maintaining availability of medicines
Q12. Which of the following is a direct consequence of fixing ceiling prices under DPCO 2013?
- All branded drugs become generic
- Manufacturers must not sell above the ceiling price for scheduled formulations
- Manufacturers get tax exemptions automatically
- Clinical efficacy tests are abolished
Correct Answer: Manufacturers must not sell above the ceiling price for scheduled formulations
Q13. What role does the National List of Essential Medicines (NLEM) play in DPCO 2013?
- NLEM is irrelevant to DPCO and not referenced
- NLEM helps identify formulations for potential price control
- NLEM sets manufacturing quality standards only
- NLEM lists vitamins and supplements excluded from DPCO
Correct Answer: NLEM helps identify formulations for potential price control
Q14. Under DPCO 2013, which term best describes the price set by NPPA that manufacturers cannot exceed?
- Reserve price
- Ceiling price
- Wholesale margin
- Suggested retail price
Correct Answer: Ceiling price
Q15. Which stakeholder is directly impacted by DPCO 2013 obligations to apply revised prices within a specified time?
- Clinical research organizations
- Drug manufacturers and marketers
- Medical colleges only
- Patent examiners
Correct Answer: Drug manufacturers and marketers
Q16. One objective of DPCO 2013 is to promote transparency. Which practice by NPPA supports this?
- Keeping ceiling price calculations confidential
- Publishing price fixation methodologies and notifications publicly
- Allowing only industry insiders to view price lists
- Fixing prices through closed-door meetings
Correct Answer: Publishing price fixation methodologies and notifications publicly
Q17. DPCO 2013 includes provisions for non-scheduled formulations. Which statement is true?
- Non-scheduled formulations are automatically exempt from all controls forever
- Non-scheduled formulations may be brought under control if deemed essential
- Non-scheduled formulations cannot be sold in India
- Non-scheduled formulations must follow international pricing only
Correct Answer: Non-scheduled formulations may be brought under control if deemed essential
Q18. Which of the following best describes the rationale for using market-based pricing in DPCO 2013?
- To ensure prices match international retail rates
- To derive ceiling prices reflecting prevailing domestic market dynamics
- To allow collusion among manufacturers
- To ignore consumer affordability
Correct Answer: To derive ceiling prices reflecting prevailing domestic market dynamics
Q19. Under DPCO 2013, penalties for overcharging a scheduled formulation are imposed by:
- State pharmacy councils
- National Pharmaceutical Pricing Authority (NPPA) or courts on NPPA reference
- World Health Organization
- District magistrates only
Correct Answer: National Pharmaceutical Pricing Authority (NPPA) or courts on NPPA reference
Q20. When calculating ceiling price, NPPA may consider price of which of the following formulations?
- Only the cheapest generics available
- Only imported brands above 50% market share
- All brands of the same formulation and strength meeting market share criteria
- Prices of unrelated therapeutic groups
Correct Answer: All brands of the same formulation and strength meeting market share criteria
Q21. Which of the following is an expected benefit of DPCO 2013 for public health?
- Reduced access to essential medicines due to price caps
- Improved affordability leading to better adherence to treatments
- Higher out-of-pocket costs for patients
- Restriction of generic competition
Correct Answer: Improved affordability leading to better adherence to treatments
Q22. Under DPCO 2013, how are combination products treated for price fixation?
- Combination products are always excluded from price control
- They are assessed based on therapeutic equivalence and market data to determine inclusion
- They are priced based solely on active pharmaceutical ingredient (API) cost
- They are automatically controlled if any single component is controlled
Correct Answer: They are assessed based on therapeutic equivalence and market data to determine inclusion
Q23. Which component is NOT directly part of the NPPA’s ceiling price formula approach under DPCO 2013?
- Weighted average price of qualifying brands
- Inclusion of retailer and wholesaler margins after ceiling setting
- Consideration of price notified by NPPA historically
- Direct use of manufacturer’s profit declaration without market data
Correct Answer: Direct use of manufacturer’s profit declaration without market data
Q24. DPCO 2013 encourages rational pricing. Which pharmacist action aligns with this objective?
- Prescribing the most expensive brand irrespective of need
- Substituting with therapeutically equivalent, affordable options when appropriate
- Refusing to stock scheduled formulations
- Altering formulation composition to evade control
Correct Answer: Substituting with therapeutically equivalent, affordable options when appropriate
Q25. Which of the following statements about DPCO 2013 and exports is correct?
- DPCO ceiling prices apply to exports and restrict foreign sales
- Exports are outside the scope of DPCO domestic ceiling prices but domestic supply remains regulated
- DPCO bans all exports of scheduled formulations
- Exports set the domestic ceiling price automatically
Correct Answer: Exports are outside the scope of DPCO domestic ceiling prices but domestic supply remains regulated
Q26. How does DPCO 2013 address new drug formulations that enter the market after notification?
- They are immediately scheduled without assessment
- They may be assessed and added to the scheduled list if essential and meeting criteria
- They are permanently exempt from any future price control
- They must be developed only by public sector units
Correct Answer: They may be assessed and added to the scheduled list if essential and meeting criteria
Q27. One of the objectives of DPCO 2013 is to check unreasonable profit margins. Which mechanism helps achieve this?
- Allowing unlimited retail markups
- Fixing ceiling prices and monitoring market compliance
- Removing all competition from the market
- Subsidizing only multinational companies
Correct Answer: Fixing ceiling prices and monitoring market compliance
Q28. Who can challenge NPPA’s decisions on price fixation under DPCO 2013?
- No one; NPPA decisions are absolute and unreviewable
- Only the central government can challenge
- Manufacturers or stakeholders can approach courts or tribunals for review
- Only foreign companies can challenge
Correct Answer: Manufacturers or stakeholders can approach courts or tribunals for review
Q29. DPCO 2013 emphasizes access to essential medicines. Which policy complements this aim in the Indian context?
- Promotion of irrational fixed-dose combinations
- National List of Essential Medicines (NLEM) and public procurement
- Restriction of generic manufacturing
- Exclusive patents for all small molecule drugs
Correct Answer: National List of Essential Medicines (NLEM) and public procurement
Q30. For a B.Pharm student, understanding the objectives of DPCO 2013 is important because:
- It only affects industrial chemistry and has no clinical relevance
- It informs ethical dispensing, pricing compliance, and public health impact
- It replaces the need to learn pharmacology
- It mandates pharmacists to set their own arbitrary prices
Correct Answer: It informs ethical dispensing, pricing compliance, and public health impact
I am a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. I hold a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research. With a strong academic foundation and practical knowledge, I am committed to providing accurate, easy-to-understand content to support pharmacy students and professionals. My aim is to make complex pharmaceutical concepts accessible and useful for real-world application.
Mail- Sachin@pharmacyfreak.com