Understanding Definitions under DPCO 2013 is essential for B.Pharm students preparing for regulatory affairs, pharmacy practice and drug price compliance. This introduction clarifies core terms — DPCO 2013, NPPA, scheduled formulation, ceiling price, price to retailer (PTR), NLEM 2011, scheduled drug, MRP and essential medicines — and explains regulatory scope, enforcement and practical implications for manufacturers, wholesalers and retailers. Emphasis is on precise statutory meanings, how ceilings are determined, what constitutes overcharging, and the role of NPPA in monitoring and recovery. These focused definitions will strengthen your conceptual foundation for pricing policy and compliance. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. What is the primary purpose of DPCO 2013?
- To regulate the trade margins of retailers only
- To control prices of scheduled formulations and protect consumer access to essential medicines
- To ban the sale of all non-scheduled drugs
- To endorse marketing strategies for pharmaceutical companies
Correct Answer: To control prices of scheduled formulations and protect consumer access to essential medicines
Q2. Which authority is responsible for implementation and enforcement of DPCO 2013?
- Central Drugs Standard Control Organization (CDSCO)
- Ministry of Health and Family Welfare
- National Pharmaceutical Pricing Authority (NPPA)
- State Drug Controllers
Correct Answer: National Pharmaceutical Pricing Authority (NPPA)
Q3. Under DPCO 2013, what is a “scheduled formulation”?
- A formulation that is exported only
- A formulation included in the National List of Essential Medicines (NLEM 2011) with specified strength and dosage form
- Any new drug introduced after 2013
- A formulation sold exclusively through hospital pharmacies
Correct Answer: A formulation included in the National List of Essential Medicines (NLEM 2011) with specified strength and dosage form
Q4. What does “ceiling price” mean in the context of DPCO 2013?
- The maximum retail price a consumer can be charged including taxes
- The minimum price at which a drug must be sold to hospitals
- The maximum price at which a scheduled formulation can be sold by the manufacturer/wholesaler to the retailer (price to retailer)
- The recommended price for marketing by manufacturers
Correct Answer: The maximum price at which a scheduled formulation can be sold by the manufacturer/wholesaler to the retailer (price to retailer)
Q5. Which list is used by DPCO 2013 to identify medicines for price control?
- Indian Pharmacopoeia (IP)
- National Formulary of India (NFI)
- National List of Essential Medicines (NLEM 2011)
- WHO Essential Medicines List exclusively
Correct Answer: National List of Essential Medicines (NLEM 2011)
Q6. What is the difference between MRP and Price to Retailer (PTR)?
- MRP is the price charged to the retailer; PTR is price printed on pack
- MRP is a wholesale price; PTR is the consumer price
- MRP is the maximum retail price printed for consumers; PTR is the price at which manufacturer/wholesaler sells to the retailer
- They are identical under DPCO 2013
Correct Answer: MRP is the maximum retail price printed for consumers; PTR is the price at which manufacturer/wholesaler sells to the retailer
Q7. Which of the following is a statutory role of NPPA under DPCO 2013?
- Issuing manufacturing licenses to drug companies
- Fixing ceiling prices for scheduled formulations and monitoring their compliance
- Approving clinical trial protocols
- Conducting drug quality testing in laboratories
Correct Answer: Fixing ceiling prices for scheduled formulations and monitoring their compliance
Q8. A “non-scheduled formulation” under DPCO 2013 refers to:
- A formulation included in NLEM 2011
- A formulation not listed in NLEM 2011 and therefore not subject to scheduled price controls
- A formulation that has been banned from sale
- A formulation priced exclusively by NPPA
Correct Answer: A formulation not listed in NLEM 2011 and therefore not subject to scheduled price controls
Q9. Which parameter is primarily considered when determining whether two products are comparable for ceiling price calculation?
- Brand reputation
- Strength and dosage form (same formulation)
- Manufacturer size
- Marketing spend
Correct Answer: Strength and dosage form (same formulation)
Q10. What action can NPPA take if a manufacturer overcharges beyond the ceiling price?
- Grant a retrospective price increase
- Recover the overcharged amount and impose penalties as per provisions
- Authorize continued sale at overcharged price for six months
- Transfer the case to local police without financial recovery
Correct Answer: Recover the overcharged amount and impose penalties as per provisions
Q11. Which of the following best describes “scheduled drug” in DPCO 2013 terminology?
- Any drug registered with CDSCO irrespective of list inclusion
- A drug composition or formulation that appears in NLEM 2011 and is thus subject to price regulation
- Only injectable formulations
- Any over-the-counter (OTC) medicine
Correct Answer: A drug composition or formulation that appears in NLEM 2011 and is thus subject to price regulation
Q12. What does “formulation” specifically mean under DPCO 2013 definitions?
- The brand name used for marketing
- The combination of active ingredient, strength and dosage form
- The method of packaging only
- The sale channel of the product
Correct Answer: The combination of active ingredient, strength and dosage form
Q13. Which of the following would classify a Fixed Dose Combination (FDC) as a scheduled formulation?
- If the FDC is manufactured by a multinational company
- If the FDC appears in NLEM 2011 with specified strength and dosage form
- If the FDC is sold only in government hospitals
- If the FDC is a nutraceutical
Correct Answer: If the FDC appears in NLEM 2011 with specified strength and dosage form
Q14. Which statement about the scope of DPCO 2013 is correct?
- It regulates prices of all imported drugs only
- It applies to scheduled formulations specified under NLEM 2011 and empowers NPPA to fix ceiling prices
- It sets production quotas for manufacturers
- It controls advertising budgets of drug companies
Correct Answer: It applies to scheduled formulations specified under NLEM 2011 and empowers NPPA to fix ceiling prices
Q15. Under DPCO 2013, who is primarily responsible for ensuring that the sale price to a retailer does not exceed the ceiling price?
- The retailer alone
- The manufacturer or marketer who sells to the retailer
- The consumer
- The advertising agency
Correct Answer: The manufacturer or marketer who sells to the retailer
Q16. Which of the following is considered an “essential medicine” in the context of DPCO?
- Any cosmetic product
- A medicine listed in NLEM intended to meet priority health care needs
- A herbal supplement marketed for wellness
- A veterinary medicine
Correct Answer: A medicine listed in NLEM intended to meet priority health care needs
Q17. What is meant by “overcharging” under price control regulations?
- Charging less than the production cost
- Selling a scheduled formulation to the retailer at a price higher than the notified ceiling price
- Offering discounts to consumers
- Exporting a drug at a higher price
Correct Answer: Selling a scheduled formulation to the retailer at a price higher than the notified ceiling price
Q18. Which of the following is NOT a direct function of NPPA?
- Fixing ceiling prices for scheduled formulations
- Monitoring prices and availability of controlled drugs
- Issuing marketing approvals for new drugs
- Recovering overcharged amounts from manufacturers
Correct Answer: Issuing marketing approvals for new drugs
Q19. How does DPCO 2013 identify comparable products for setting a ceiling price?
- Based on similar packaging color
- Based on same active ingredient, strength and dosage form
- Based on company turnover
- Based on year of launch only
Correct Answer: Based on same active ingredient, strength and dosage form
Q20. What document typically displays the MRP that a consumer pays?
- Price list from NPPA
- Invoice only
- Printed MRP on the product pack/container
- Manufacturer internal memo
Correct Answer: Printed MRP on the product pack/container
Q21. If a formulation is removed from NLEM, what is the immediate implication under DPCO 2013?
- It automatically becomes a banned product
- It may cease to be a scheduled formulation and may no longer be subject to ceiling price controls
- It must be sold only to hospitals
- Its manufacturing license is revoked
Correct Answer: It may cease to be a scheduled formulation and may no longer be subject to ceiling price controls
Q22. Which governmental action notifies DPCO 2013?
- Notification by the Central Government under the Essential Commodities Act
- State legislature act
- Order by the World Health Organization
- Directive from individual manufacturers
Correct Answer: Notification by the Central Government under the Essential Commodities Act
Q23. What role does NLEM 2011 play in drug price regulation?
- It prescribes clinical trial procedures
- It lists essential medicines which determine scheduled formulations for price control
- It sets the retail margins for pharmacies
- It controls import tariffs on medicines
Correct Answer: It lists essential medicines which determine scheduled formulations for price control
Q24. Which of the following factors is directly used by NPPA when computing ceiling price for a scheduled formulation?
- Average PTR of all brands of the same strength and dosage form
- Manufacturing cost of the largest manufacturer only
- Profit margins declared by retailers
- Advertising expenditure of manufacturers
Correct Answer: Average PTR of all brands of the same strength and dosage form
Q25. Under DPCO 2013, who can be held liable for sale at prices above the ceiling?
- Only retailers
- Manufacturers, marketers and wholesalers who sell to retailers above the ceiling price
- Only the transporters
- Consumers who pay more
Correct Answer: Manufacturers, marketers and wholesalers who sell to retailers above the ceiling price
Q26. What is the immediate consumer-level indicator that a product is regulated under price control?
- The product is available only by prescription
- The product pack may show MRP but consumer awareness of price control is from NPPA notices and public lists
- The packaging will be in a specific color mandated by NPPA
- The product will be distributed free of cost
Correct Answer: The product pack may show MRP but consumer awareness of price control is from NPPA notices and public lists
Q27. Which statement about scheduled formulations and brands is correct?
- Only the innovator brand of a scheduled formulation is regulated
- All brands of the same scheduled formulation are subject to the ceiling price policy
- Only generic brands are regulated under DPCO 2013
- Brands with less than one year of sales are exempt
Correct Answer: All brands of the same scheduled formulation are subject to the ceiling price policy
Q28. Which of the following best describes the NPPA’s power regarding price revision?
- NPPA cannot revise prices once fixed
- NPPA can revise ceiling prices based on statutory procedures and market data
- NPPA can unilaterally fix retail margins
- NPPA sets prices for all non-drug consumer goods
Correct Answer: NPPA can revise ceiling prices based on statutory procedures and market data
Q29. What does MRP stand for and indicate?
- Maximum Retail Price; the maximum price printed on the pack at which the consumer can buy the product
- Minimum Resale Price; the lowest price allowed for wholesalers
- Market Reference Price; a suggested trade price
- Manufacturer Recommended Profit; guidance for pricing
Correct Answer: Maximum Retail Price; the maximum price printed on the pack at which the consumer can buy the product
Q30. Which enforcement mechanism is commonly used by NPPA when irregularities are detected?
- Issuing marketing authorization to new companies
- Recovery of overcharged amounts from the offending parties and imposing penalties
- Shutting down all pharmacies nationwide
- Granting tax exemptions to manufacturers
Correct Answer: Recovery of overcharged amounts from the offending parties and imposing penalties
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.
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