D&MR Act, Prevention of Cruelty to Animals Act & DPCO 2013
Syllabus & Topics
- 1Drugs & Magic Remedies Act 1954 – Objectives: (1) Prevent misleading advertisements relating to drugs and magic remedies. (2) Prohibit advertisements claiming miraculous cures for diseases listed in the Schedule. (3) Control false claims regarding drugs’ efficacy. The Act applies to ALL forms of advertising — print, radio, TV, outdoor, and now digital/social media.
- 2D&MR Act – Key Definitions: ‘Advertisement’ includes any notice, circular, label, wrapper or other document and any announcement by any means. ‘Drug’ has the same meaning as in D&C Act + Ayurvedic, Siddha, Unani medicines. ‘Magic Remedy’ includes talisman, mantra, kavacha, or any other charm that claims to possess miraculous powers for diagnosis, cure, or prevention of disease.
- 3D&MR Act – Prohibited Advertisements (Section 3): No person shall take part in publication of any advertisement referring to any drug that gives false impression about its nature, composition, or effects; is misleading; makes false claims about curing any disease. Schedule lists 54 diseases/conditions for which NO drug advertisement is permitted: includes cancer, diabetes, epilepsy, heart disease, blindness, baldness, sexual impotence.
- 4D&MR Act – Exempted Advertisements (Section 14): Exemptions: (1) Advertisements to registered medical practitioners. (2) Signs/labels on registered pharmacies. (3) Drug trade circulars to wholesale/retail dealers. (4) Reference books and pharmacopoeias. (5) Government publications. (6) Journal articles of scientific nature.
- 5D&MR Act – Offences & Penalties: First offence: imprisonment up to 6 months or fine or both. Subsequent offence: imprisonment up to 1 year or fine or both. If advertisement is published in newspaper/periodical, the editor, publisher, and proprietor are all liable unless they prove they had no knowledge.
- 6Prevention of Cruelty to Animals Act 1960 – Objectives: (1) Prevent infliction of unnecessary pain or suffering on animals. (2) Amend law relating to prevention of cruelty to animals. (3) Establish the Animal Welfare Board of India. (4) Regulate the performance of experiments on animals. Important: does NOT ban animal experiments but regulates them strictly.
- 7CPCSEA: Committee for the Purpose of Control and Supervision of Experiments on Animals – statutory body under the Act. Functions: (1) Register establishments conducting animal experiments. (2) Inspect registered establishments. (3) Approve experimental protocols. (4) Ensure compliance with guidelines. (5) Power to suspend or revoke registration.
- 8Institutional Animal Ethics Committee (IAEC): Every establishment using animals must constitute an IAEC. Composition: biological scientist, two scientists from different disciplines, a veterinarian, a CPCSEA nominee (social worker), and the head of institution. Functions: approve/review all animal experiment proposals, ensure 3R principles (Replacement, Reduction, Refinement), maintain records.
- 9CPCSEA Guidelines – Breeding, Experiments, Records: Only purpose-bred animals from registered breeders. Standard housing, feeding, and veterinary care. Anesthesia mandatory during painful procedures. Post-experimental care until recovery or humane euthanasia. Detailed records of all animals (acquisition, experiments performed, disposition) maintained and submitted to CPCSEA. Transfer of animals between institutions requires prior CPCSEA approval.
- 10Offences & Penalties – PCA Act: Treating animals cruelly: first offence fine ₹10-50, subsequent fine ₹25-100 or imprisonment up to 3 months. Performing experiments without CPCSEA registration: registration revoked + prosecution. Violating CPCSEA guidelines: suspension of registration, seizure of animals.
- 11DPCO 2013 – Objectives & Background: Drug Price Control Order issued under the Essential Commodities Act, 1955. Objective: Ensure essential medicines remain affordable and accessible. Administered by the National Pharmaceutical Pricing Authority (NPPA), an independent body under the Department of Pharmaceuticals. Replaces DPCO 1995 with a market-based pricing approach.
- 12DPCO 2013 – Key Definitions: ‘Scheduled Formulation’ = formulation listed in the NLEM (National List of Essential Medicines). ‘Non-scheduled Formulation’ = not in NLEM. ‘Ceiling Price’ = maximum price fixed by NPPA for scheduled formulations based on simple average of all brands with ≥1% market share. ‘Retail Price’ = price to consumer including manufacturer’s price + trade margin (not exceeding 16% for scheduled drugs).
- 13DPCO 2013 – Pricing Mechanism: Ceiling price for scheduled formulations = Simple average of prices of all brands having ≥1% market share of that particular formulation (weighted by moving annual turnover). No company can sell above ceiling price. For new drugs: NPPA may fix price based on cost-based formula. Annual price increase: linked to WPI (Wholesale Price Index) — maximum 10% for non-scheduled drugs under Para 20.
- 14National List of Essential Medicines (NLEM): List of essential medicines whose prices are controlled under DPCO 2013. Current NLEM 2022: includes 384 drugs across 27 therapeutic categories. Covers antibiotics, antihypertensives, antidiabetics, vaccines, etc. Revised periodically by a government committee. Selection based on: disease burden in India, safety, efficacy, and cost-effectiveness.
- 15NPPA – Functions & Powers: (1) Fix/revise ceiling prices of scheduled formulations. (2) Monitor prices of non-scheduled formulations. (3) Implement and enforce DPCO provisions. (4) Recover overcharged amounts from companies. (5) Maintain data on drug production and prices. (6) Advise government on drug pricing policy. NPPA can fix even non-scheduled drug prices in ‘extraordinary circumstances’ (e.g., Coronary Stents, Knee Implants capped at 70-80% reduction).
Learning Objectives
Exam Prep Questions
Q1. Can Pharmaceutical Companies Advertise Prescription Drugs to the Public?
Under the Drugs and Magic Remedies (Objectionable Advertisements) Act 1954, pharmaceutical companies are not allowed to advertise prescription drugs directly to the general public. Medicines listed under Schedule H and Schedule X cannot be promoted through public advertisements because they require medical supervision. Additionally, the Drugs and Cosmetics Act 1940 prohibits misleading or false drug advertisements. Only over-the-counter (OTC) medicines may be advertised to the public, and even then the claims must be truthful and not exaggerated. However, promotion of prescription drugs to registered medical practitioners through medical representatives, scientific meetings, and medical journals is permitted.
Q2. What Are the 3Rs in Animal Experimentation?
The ethical principles of animal experimentation are guided by the “3Rs,” which are enforced by the Committee for the Purpose of Control and Supervision of Experiments on Animals. Replacement refers to the use of alternative methods such as in-vitro techniques, computer simulations, or cell cultures instead of animals whenever possible. Reduction means minimizing the number of animals used while still obtaining scientifically valid results. Refinement involves modifying experimental procedures to reduce pain, suffering, or distress to animals by using proper anesthesia, humane endpoints, and improved animal care.
Q3. How Does NPPA Fix Ceiling Prices for Medicines?
National Pharmaceutical Pricing Authority determines the ceiling price for essential medicines listed in the National List of Essential Medicines. According to the Drugs Price Control Order 2013, the ceiling price is calculated as the simple average of the prices of all brands with at least 1% market share, based on market data obtained from sources such as IQVIA. Retailers are allowed a maximum trade margin of about 16% on scheduled formulations. For non-scheduled drugs, companies may increase prices by a maximum of 10% per year, although NPPA can intervene in exceptional situations in the public interest.
Q4. What Is the Difference Between Scheduled and Non-Scheduled Formulations?
Scheduled formulations are medicines included in the National List of Essential Medicines and are therefore subject to strict price regulation under the Drugs Price Control Order 2013. The NPPA sets a ceiling price for these medicines, and manufacturers cannot sell them above that price. Non-scheduled formulations are drugs that are not included in the NLEM. Their prices are not directly fixed by NPPA, but manufacturers are allowed to increase the price only up to 10% per year. NPPA monitors these drugs and may intervene if prices rise excessively.
Q5. What Is the Penalty for Selling Drugs Above the Ceiling Price?
If a pharmaceutical company sells a scheduled formulation above the ceiling price fixed under the Drugs Price Control Order 2013, it must immediately reduce the price to the approved level. The company must also deposit the overcharged amount along with interest (approximately 15% per annum) with the National Pharmaceutical Pricing Authority. In serious cases, prosecution may also occur under the Essential Commodities Act 1955, which may result in imprisonment of up to seven years.